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    While George's online drugstore is out of commission, rogue pharmacies remain, enabling Americans to illegally buy narcotics and other addictive drugs.
    In fact, Internet pill peddlers never had it so good: A Palm Beach Post review of sites found they're aided by major companies, a loophole in a well-intentioned law and an abundance of offshore havens stretching from Ukraine to China.
    These online sellers have homegrown ties. Sites examined by The Post typically relied on a U.S. Web support operation. In addition, social media such as Facebook and Twitter are used to hawk drugs, and rogue pharmacies are as close as a search on Google.
    More troubling, a rise in Internet narcotics purchases is expected as regional pill mills shutter and addicts scramble for other sources of such popular and deadly narcotics as oxycodone. That's a particular concern for Florida: Prescription drug overdoses caused more deaths than traffic accidents in the state last year.
    "Crack down on pill mills, and people will go to the 'Net because it's an easy source - and they deliver to your front door," said Dr. Bryan Liang, vice president of Partnership for Safe Medicines, an advocacy group.
    "Online sales are on the rise over the past year," confirmed Ira Levy of Sunrise Detox, a substance abuse treatment center. "We've seen it grow."
    Despite the surge, it's against federal law to possess narcotics without a valid prescription - or to sell them online without such a prescription. Sites examined by The Post did offer to sell without a prescription, though. Others provided a cursory written or oral "exam" with a physician, or sold access to other sites that directly sell drugs without a face-to-face consultation with a doctor.
    "I found 10 sites in 10 minutes," said Sean Ryan, an addiction specialist at West Palm Beach's Hanley Center. "Basically, you can buy anything online."
    Covering tracks
    Take Medsindia.com. Tap a few keys, and Medsindia promises you can pick up 120 pills of Darvocet, a painkiller banned in the United States and Europe, for $238.80. No proof of a prescription is needed.
    Tijuana Pharmacy offers 10 tabs of OxyContin for $450. Foreign Drugstores Online advertises access to pharmacies selling morphine, 30 tabs for $100.
    Despite the foreign-sounding names, they're not entirely offshore. Foreign Drugstores Online has an address traceable to a strip mall in Pasadena, Calif.
    Medsindia's contact person, according to its website registration, is Larry Burstein, who lists a Wyoming phone number. The company that maintains the website's online address is based in Virginia. Identified in 10-year-old media reports as a former traveling salesman from Buffalo, N.Y., a Larry Burstein previously operated an "international" online drug information website from a home in Sarasota.
    Burstein doesn't live there, according to the current occupant, and calls to the Wyoming number weren't answered.
    Online 'Where's Waldo?'
    That's not to say foreign interests aren't involved, especially from Russia. "Mike Gorbachev" from Kiev, Ukraine, is the point person for dumbangelmagazine.com, which heavily marketed Soma, a prescription tranquilizer. Dumbangel brings an Internet buyer to another site, which accepts the drug orders. That site is linked by an international watchdog group to Yambo Financials, shadowy Russian-based spammers who specialize in child, incest and animal pornography as well as financial scams and pharmaceuticals.
    More often, determining where the site originates is a mystery worthy of Where's Waldo?
    Take Pharmacy4Pills. The company that handled its Web registration appears to be a corporation in the Bahamas; its Internet address is handled by a company in Pennsylvania; and the contact person is in Vanuatu, a tiny South Pacific archipelago - using a disconnected Atlanta phone number.
    Neither are mail shipping labels any guarantee of location. Liang points out pharmacies may ship drugs to one customer using another customer's return address.
    "It's a bit of an underground world," said Alina Halloran, a vice president with OpSec Security, another anti-counterfeiting concern whose clients include pharmaceutical firms - but not so underground that a dedicated drug-seeker can't find plenty of sites.
    After all, said Mathea Falco, founder of Drug Strategies, a Washington-based research foundation, "They want to be found."
    Googling for drugs
    Major U.S. companies have denounced rogue online pharmacy operations only to be caught up in the business. Both Mastercard and Visa were advertised as accepted at certain pharmacies examined by The Post. Some use the U.S. mail. Godaddy.com, an online domain-hosting service, played a legal part in getting the Yambo-connected pharmacy up and running.
    Google has a role, as well. The search engine giant recently agreed to pay $500 million to settle charges that it advertised online Canadian pharmacies targeting consumers in the United States. Years prior to the settlement, Google had adopted a self-imposed ban on advertising by rogue pharmacies, which is separate from search engine results. "It won't say 'Buy Vicodin here,' " then-Google executive Sheryl Sandberg said at the time. And ads don't.
    However, using those exact words, the Google search engine pulls up lists of online pharmacy sites offering Vicodin without a prescription.
    It's not just U.S.-based search engines linking to rogue pharmacies.
    "Currently, the problem is the social media, Twitter and Facebook," Liang said. "Months ago, we did a search on Facebook and Twitter looking for online drugs. We found them," he said, but not in great numbers. "Well, six to eight months later we checked again and they had infiltrated everywhere."
    The Post easily found Facebook sites hawking Vicodin, Soma and Valium. Twitter sites offered ads for OxyContin and methadone.
    A spokeswoman for Facebook said of the sites, "We remove them when we learn about them," alerted in part from self-reporting by Facebook's 800 million users who "keep an eye out for illegal content." Twitter did not respond to written requests for comment.
    As for Google, a company spokeswoman said, "Search results are a reflection of the content of the Web." The search engine can remove content, but doesn't do so "except in narrow cases," such as child pornography.
    Not every site that claims to take Mastercard actually does, a company spokesman said. When the credit-card issuer becomes aware of illicit activity, it cuts them off. And Mastercard and Visa don't have direct links to the sites, a Visa spokesman emphasized. Rather, it's the financial institutions doing business with the card issuers.
    Web support key
    Rogue pharmacies have other U.S. help. Of 24 sites examined by The Post, 20 had either a U.S. link or Web support service provided by U.S. companies.
    In a suburb outside New Orleans, for instance, Directnic Inc. handles certain web operations of Primerxoffer.com. Primerxoffer advertises that it will link customers to no-prescription sales of such items as Valium and Soma. Primerxoffer has been linked to a Middle-Eastern organized crime ring, said John Horton, a former Bush White House anti-drug crusader and founder of LegitScript, which tracks online pharmacies.
    To understand the key role web support companies play, consider domain name servers. Such services link the name of a site, such as Medsindia.com, to the site's numerical address, known as the IP address. Without such links, it is almost impossible for Internet surfers to find their way to a site.
    Domain name service companies have the ability to "freeze" a site's name for years at a time, effectively shutting it down. "It's like throwing sand in the wheels," said Drug Strategies' Falco. "The more sand, the harder it is to operate."
    But some companies won't act, Halloran said. "They will say they're not interested in the problem, it's not their problem, they're just assigning domain names," she said.
    Private company assistance in shuttering the sites is all the more important because law enforcement faces sizeable hurdles in running down Internet pharmacies. For one thing, they vanish and then pop up again under another name with dizzying speed. "They're like desert flowers; they bloom for a moment and disappear," Falco said.
    No prescription needed
    The online sale of narcotics without a prescription was supposed to have been remedied by the 2008 passage of the Ryan Haight Act, named after a California teenager who fatally overdosed after buying Vicodin over the Internet.
    Among other things, the act has made it illegal to sell certain drugs online without a prescription obtained in a face-to-face consultation with a doctor.
    Haight never saw a doctor. Neither did Robin Bartlett, 44, a Sarasota mother of two who died in 2003 after buying 4,000 doses from 19 pharmacies in the last four months of her life.
    Frequently, rogue online pharmacies simply offer customers the option of an online consultation with a doctor or filling out a questionnaire which, they promise, will be reviewed by a doctor. Here's how Arkansas-based PharmacySources.com recently described it: "The consultations are very stress free and usually last from 5 to 15 minutes. Depending on your needs, (doctors) usually prescribe between 60-360 (per month) hydrocodone based meds, such as Vicodin, Norco, Lorcet, or whatever medication that you may need with a refill for 3-6 months."
    The new law doesn't make it illegal to buy narcotics online, though other laws make it illegal to either possess or attempt to possess them without a valid prescription. The law sets sales rules for pharmacies, including those overseas that sell to Americans.
    Enforcing the new law, Robert Hill, chief of the Drug Enforcement Administration's pharmaceutical investigations section, said last year, "We've pretty much pushed them (rogue pharmacies) off domestic soil."
    "Well that's not true, it's just not true," Horton responded. "We find (rogue pharmacies) all the time."
    Horton and LegitScript have catalogued more than 1,000 rogue pharmacies, he said. Records gathered by OpSec conclude that the number of pharmacies dispensing meds without a prescription actually grew between 2008 and 2009.
    Even if true, pushing online pharmacies offshore may not be much of a victory: DEA Administrator Michele Leonhart conceded in congressional testimony in May that, "The problem has not been resolved with regard to foreign-based Internet pharmacies."
    Pill-mill connection
    Clearing out pain clinics that have plagued South Florida remains the DEA's priority, said Gary Hobbs, a supervisory agent. "You may have a leaking water pipe in the basement that needs to be fixed, but if there is also a break in the water main, which one would you fix first?" Hobbs said.
    Palm Beach County State Attorney Michael McAuliffe, who has led the local fight to shutter pain clinics, said the issue is on his office's radar, but, he pointed out, when the transactions are international in scope, it becomes a federal issue, to be addressed by the DEA.
    Meanwhile, even brick-and-mortar pill mills have gotten in on the act. "We have actually seen evidence that pain clinics are also doing enormous Internet business behind the counter," Halloran said.
    One example: In August, federal charges were filed against four local businesses, including Palm Beach Life Extension and the Health and Rejuvenation Clinic, both in Palm Beach Gardens, and Millenium Health Services in Stuart.
    There, prosecutors say, an array of controlled drugs were being illegally sold. At Millenium, steroids were being sold over the Internet, the indictment charges.
    Horton can foresee a day when the number of web support services willing to tolerate such rogue pharmacies dwindles - but not right away. Sales are such profitable ventures, he said, "there's incentive for bad actors to continue to set up as many of these sites as often as they can."

    OxyContin contains oxycodone which is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

    OxyContin can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
    OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
    OxyContin Tablets are not intended for use on an as needed basis.
    Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
    OxyContin 60 mg, 80 mg, and 160 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant or sedating effects of opioids.
    Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction.
    OxyContin must be swallowed whole and must not be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.
    The concomitant use of OxyContin with all cytochrome P450 3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir) may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse effects and may cause potentially fatal respiratory depression. Patients receiving OxyContin and a CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.

    DESCRIPTION
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets are an opioid analgesic supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:

    The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
    Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin.
    The 10 mg tablets also contain: hydroxypropyl cellulose.
    The 15 mg tablets also contain: black iron oxide, yellow iron oxide, and red iron oxide.
    The 20 mg tablets also contain: polysorbate 80 and red iron oxide.
    The 30 mg tablets also contain: polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide.
    The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide.
    The 60 mg tablets also contain: polysorbate 80 and FD&C Red No. 40 Aluminum Lake
    The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide.
    The 160 mg tablets also contain: FD&C blue No. 2 and polysorbate 80.
    OxyContin® 10 mg, 20 mg, 40 mg, and 80 mg Tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.
    OxyContin® 15 mg, 30 mg, and 60 mg Tablets are not described in the USP but are tested using USP Dissolution Test 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.

    CLINICAL PHARMACOLOGY
    Oxycodone is a pure agonist opioid whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, hydromorphone, fentanyl, codeine, and hydrocodone. Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, and cough suppression, as well as analgesia. Like all pure opioid agonist analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/antagonists or non-opioid analgesics, where there is a limit to the analgesic effect with increasing doses. With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression.

    Central Nervous System
    The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.
    Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation.
    Oxycodone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia.
    Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of OxyContin® overdose (See OVERDOSAGE).

    Gastrointestinal Tract And Other Smooth Muscle
    Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

    Cardiovascular System
    Oxycodone may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

    Concentration – Efficacy Relationships
    Studies in normal volunteers and patients reveal predictable relationships between oxycodone dosage and plasma oxycodone concentrations, as well as between concentration and certain expected opioid effects, such as pupillary constriction, sedation, overall "drug effect", analgesia and feelings of "relaxation".
    As with all opioids, the minimum effective plasma concentration for analgesia will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. As a result, patients must be treated with individualized titration of dosage to the desired effect. The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance.

    Concentration – Adverse Experience Relationships
    OxyContin® Tablets are associated with typical opioid-related adverse experiences. There is a general relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse experiences such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation is altered by the development of tolerance to opioid-related side effects, and the relationship is not clinically relevant.
    As with all opioids, the dose must be individualized (see DOSAGE AND ADMINISTRATION), because the effective analgesic dose for some patients will be too high to be tolerated by other patients.

    PHARMACOKINETICS AND METABOLISM
    The activity of OxyContin Tablets is primarily due to the parent drug oxycodone. OxyContin Tablets are designed to provide controlled delivery of oxycodone over 12 hours.
    Cutting, breaking, chewing, crushing or dissolving OxyContin Tablets eliminates the controlled delivery mechanism and results in the rapid release and absorption of a potentially fatal dose of oxycodone.
    Oxycodone release from OxyContin Tablets is pH independent. Oxycodone is well absorbed from OxyContin Tablets with an oral bioavailability of 60% to 87%. The relative oral bioavailability of OxyContin to immediate-release oral dosage forms is 100%. Upon repeated dosing in normal volunteers in pharmacokinetic studies, steady-state levels were achieved within 24-36 hours. Dose proportionality and/or bioavailability has been established for the 10 mg, 20 mg, 40 mg, 80 mg, and 160 mg tablet strengths for both peak plasma levels (Cmax) and extent of absorption (AUC). Oxycodone is extensively metabolized and eliminated primarily in the urine as both conjugated and unconjugated metabolites. The apparent elimination half-life of oxycodone following the administration of OxyContin® was 4.5 hours compared to 3.2 hours for immediate-release oxycodone.

    Absorption
    About 60% to 87% of an oral dose of oxycodone reaches the central compartment in comparison to a parenteral dose. This high oral bioavailability is due to low pre-systemic and/or first-pass metabolism. In normal volunteers, the t˝ of absorption is 0.4 hours for immediate-release oral oxycodone. In contrast, OxyContin Tablets exhibit a biphasic absorption pattern with two apparent absorption half-lives of 0.6 and 6.9 hours, which describes the initial release of oxycodone from the tablet followed by a prolonged release.

    Plasma Oxycodone by Time
    Dose proportionality has been established for the 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for both peak plasma concentrations (Cmax) and extent of absorption (AUC) (see Table 1 below). Another study established that the 160 mg tablet is bioequivalent to 2 x 80 mg tablets as well as to 4 x 40 mg for both peak plasma concentrations (Cmax) and extent of absorption (AUC) (see Table 2 below). Given the short half-life of elimination of oxycodone from OxyContin®, steady-state plasma concentrations of oxycodone are achieved within 24-36 hours of initiation of dosing with OxyContin Tablets. In a study comparing 10 mg of OxyContin every 12 hours to 5 mg of immediate-release oxycodone every 6 hours, the two treatments were found to be equivalent for AUC and Cmax, and similar for Cmin (trough) concentrations.

    TABLE 1 Mean [% coefficient variation] Regimen Dosage Form AUC
    (ng•hr/mL)† Cmax
    (ng/mL) Tmax
    (hrs) Trough Conc.
    (ng/mL)

    Single
    Dose 10 mg OxyContin 100.7 [26.6] 10.6 [20.1] 2.7 [44.1] n.a.
    20 mg OxyContin 207.5 [35.9] 21.4 [36.6] 3.2 [57.9] n.a.
    40 mg OxyContin 423.1 [33.3] 39.3 [34.0] 3.1 [77.4] n.a.
    80 mg OxyContin* 1085.5 [32.3] 98.5 [32.1] 2.1 [52.3] n.a.

    Multiple
    Dose 10 mg OxyContin
    Tablets q12h 103.6 [38.6] 15.1 [31.0] 3.2 [69.5] 7.2 [48.1]
    5 mg immediate-
    release q6h 99.0 [36.2] 15.5 [28.8] 1.6 [49.7] 7.4 [50.9]
    TABLE 2 Mean [% coefficient variation] Regimen Dosage Form AUC∞
    (ng•hr/mL)† Cmax
    (ng/mL) Tmax
    (hrs) Trough Conc.
    (ng/mL)
    † for single-dose AUC = AUC0-inf; for multiple-dose AUC = AUC0-T
    * data obtained while volunteers received naltrexone which can enhance absorption
    Single
    Dose 4 x 40 mg
    OxyContin* 1935.3 [34.7] 152.0 [28.9] 2.56 [42.3] n.a.
    2 x 80 mg
    OxyContin* 1859.3 [30.1] 153.4 [25.1] 2.78 [69.3] n.a.
    1 x 160 mg
    OxyContin* 1856.4 [30.5] 156.4 [24.8] 2.54 [36.4] n.a.
    OxyContin® is NOT INDICATED FOR RECTAL ADMINISTRATION. Data from a study involving 21 normal volunteers show that OxyContin Tablets administered per rectum resulted in an AUC 39% greater and a Cmax 9% higher than tablets administered by mouth. Therefore, there is an increased risk of adverse events with rectal administration.

    Food Effects
    Food has no significant effect on the extent of absorption of oxycodone from OxyContin. However, the peak plasma concentration of oxycodone increased by 25% when a OxyContin 160 mg Tablet was administered with a high-fat meal.

    Distribution
    Following intravenous administration, the volume of distribution (Vss) for oxycodone was 2.6 L/kg. Oxycodone binding to plasma protein at 37°C and a pH of 7.4 was about 45%. Once absorbed, oxycodone is distributed to skeletal muscle, liver, intestinal tract, lungs, spleen, and brain. Oxycodone has been found in breast milk (see PRECAUTIONS).

    Metabolism
    Oxycodone hydrochloride is extensively metabolized to noroxycodone, oxymorphone, noroxymorphone, and their glucuronides. The major circulating metabolite is noroxycodone. Noroxycodone is reported to be a considerably weaker analgesic than oxycodone. Oxymorphone, although possessing analgesic activity, is present in the plasma only in low concentrations. The correlation between oxymorphone concentrations and opioid effects was much less than that seen with oxycodone plasma concentrations. The analgesic activity profile of other metabolites is not known.
    CYP3A mediated N-demethylation (to noroxycodone) is the primary metabolic pathway of oxycodone with a lower contribution from CYP2D6 mediated O-demethylation (to oxymorphone). Therefore, the formation of these and related metabolites can, in theory, be affected by other drugs (see Drug-Drug Interactions).

    Excretion
    Oxycodone and its metabolites are excreted primarily via the kidney. The amounts measured in the urine have been reported as follows: free oxycodone up to 19%; conjugated oxycodone up to 50%; free oxymorphone 0%; conjugated oxymorphone ≤ 14%; both free and conjugated noroxycodone have been found in the urine but not quantified. The total plasma clearance was 0.8 L/min for adults.

    Special Populations
    Elderly
    The plasma concentrations of oxycodone are only nominally affected by age, being 15% greater in elderly as compared to young subjects.

    Gender
    Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on a body weight adjusted basis. The reason for this difference is unknown.

    Renal Impairment
    Data from a pharmacokinetic study involving 13 patients with mild to severe renal dysfunction (creatinine clearance <60 mL/min) show peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher, respectively, and AUC values for oxycodone, noroxycodone, and oxymorphone 60%, 50%, and 40% higher than normal subjects, respectively. This is accompanied by an increase in sedation but not by differences in respiratory rate, pupillary constriction, or several other measures of drug effect. There was an increase in t˝ of elimination for oxycodone of only 1 hour (see PRECAUTIONS).

    Hepatic Impairment
    Data from a study involving 24 patients with mild to moderate hepatic dysfunction show peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher, respectively, than normal subjects. AUC values are 95% and 65% higher, respectively. Oxymorphone peak plasma concentrations and AUC values are lower by 30% and 40%. These differences are accompanied by increases in some, but not other, drug effects. The t˝ elimination for oxycodone increased by 2.3 hours (see PRECAUTIONS).

    Drug-Drug Interactions (see PRECAUTIONS)
    CYP3A mediated N-demethylation is the principal metabolic pathway of oxycodone with a lower contribution from CYP2D6 mediated O-demethylation and can be affected by drugs affecting cytochrome P450 enzymes. Drugs that inhibit CYP3A4 activity, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations. For example, a published study showed that the co-administration of the antifungal drug, voriconazole, increased oxycodone AUC and Cmax by 3.6 and 1.7 fold, respectively. Similarly, CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone and, therefore, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone. A published study showed that the co-administration of rifampin, a drug metabolizing enzyme inducer, decreased oxycodone (oral) AUC and Cmax by 86% and 63%, respectively.
    Oxycodone is metabolized in part by cytochrome P450 2D6 to oxymorphone which represents less than 15% of the total administered dose. This route of elimination may be blocked by a variety of drugs (e.g., certain cardiovascular drugs including amiodarone and quinidine as well as polycyclic anti-depressants). However, in a study involving 10 subjects using quinidine, a known inhibitor of cytochrome P450 2D6, the pharmacodynamic effects of oxycodone were unchanged. The genetic expression of CYP2D6 may have some influence in the pharmacokinetic properties of oxycodone.
    The in vitro drug-drug interaction studies with noroxymorphone using human liver microsomes showed no significant inhibition of CYP2D6 and CYP3A4 activities which suggests that noroxymorphone may not alter the metabolism of other drugs that are metabolized by CYP2D6 and CYP3A4, and such blockade has not been shown to be of clinical significance with oxycodone.

    Pharmacodynamics
    A single-dose, double-blind, placebo- and dose-controlled study was conducted using OxyContin® (10, 20, and 30 mg) in an analgesic pain model involving 182 patients with moderate to severe pain. Twenty and 30 mg of OxyContin were superior in reducing pain compared with placebo, and this difference was statistically significant. The onset of analgesic action with OxyContin occurred within 1 hour in most patients following oral administration.

    CLINICAL TRIALS
    A double-blind placebo-controlled, fixed-dose, parallel group, two-week study was conducted in 133 patients with chronic, moderate to severe pain, who were judged as having inadequate pain control with their current therapy. In this study, 20 mg OxyContin q12h but not 10 mg OxyContin q12h decreased pain compared with placebo, and this difference was statistically significant.

    INDICATIONS AND USAGE
    OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
    OxyContin is not intended for use on an as needed basis.
    Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for HealthCare Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society.
    OxyContin is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OxyContin is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

    CONTRAINDICATIONS
    OxyContin® is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. OxyContin is contraindicated in any patient who has or is suspected of having paralytic ileus.

    WARNINGS
    OxyContin must be swallowed whole and must not be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin Tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.
    OxyContin 60 mg, 80 mg, and 160 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory- depressant effects of opioids.
    Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
    Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

    Misuse, Abuse and Diversion of Opioids
    Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
    Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
    OxyContin has been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death (see WARNINGS and DRUG ABUSE AND ADDICTION).
    Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.
    Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

    Interactions with Alcohol and Drugs of Abuse
    Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

    DRUG ABUSE AND ADDICTION
    OxyContin® contains oxycodone, which is a full mu-agonist opioid with an abuse liability similar to morphine and is a Schedule II controlled substance. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.
    Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. There is a potential for drug addiction to develop following exposure to opioids, including oxycodone. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.
    "Drug-seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
    Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. OxyContin, like other opioids, has been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
    Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
    OxyContin consists of a dual-polymer matrix, intended for oral use only. Abuse of the crushed tablet poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. With parenteral abuse, the tablet excipients, especially talc, can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

    Respiratory Depression
    Respiratory depression is the chief hazard from oxycodone, the active ingredient in OxyContin®, as with all opioid agonists. Respiratory depression is a particular problem in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.
    Oxycodone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

    Head Injury
    The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, intracranial lesions, or other sources of pre-existing increased intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.

    Hypotensive Effect
    OxyContin may cause severe hypotension. There is an added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Oxycodone may produce orthostatic hypotension in ambulatory patients. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

    PRECAUTIONS
    General
    Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.
    Use of OxyContin® is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.
    The administration of oxycodone may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

    Interactions with other CNS Depressants
    OxyContin should be used with caution and started in a reduced dosage (1/3 to 1/2 of the usual dosage) in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual doses of OxyContin.

    Interactions with Mixed Agonist/Antagonist Opioid Analgesics
    Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.

    Ambulatory Surgery and Postoperative Use
    OxyContin is not indicated for pre-emptive analgesia (administration pre-operatively for the management of postoperative pain).
    OxyContin is not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.
    OxyContin is not indicated for pain in the postoperative period if the pain is mild or not expected to persist for an extended period of time.
    OxyContin is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (See American Pain Society guidelines).
    Patients who are already receiving OxyContin® Tablets as part of ongoing analgesic therapy may be safely continued on the drug if appropriate dosage adjustments are made considering the procedure, other drugs given, and the temporary changes in physiology caused by the surgical intervention (see DOSAGE AND ADMINISTRATION).
    OxyContin and other morphine-like opioids have been shown to decrease bowel motility. Ileus is a common postoperative complication, especially after intra-abdominal surgery with opioid analgesia. Caution should be taken to monitor for decreased bowel motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented.

    Use in Pancreatic/Biliary Tract Disease
    Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.

    Tolerance and Physical Dependence
    Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
    The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
    In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).

    Driving and Operating Machinery
    OxyContin may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Caution patients accordingly.

    Information for Patients/Caregivers
    If clinically advisable, patients receiving OxyContin Tablets or their caregivers should be given the following information by the physician, nurse, pharmacist, or caregiver:
    1.Patients should be aware that OxyContin Tablets contain oxycodone, which is a morphine-like substance.
    2.Patients should be advised that OxyContin Tablets were designed to work properly only if swallowed whole. OxyContin Tablets will release all their contents at once if cut, broken, chewed, crushed, or dissolved; resulting in a risk of fatal overdose.
    3.Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
    4.Patients should be advised not to adjust the dose of OxyContin® without consulting the prescribing professional.
    5.Patients should be advised that OxyContin may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
    6.Patients should not combine OxyContin with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.
    7.Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
    8.Patients should be advised that OxyContin is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
    9.Patients should be advised that they may pass empty matrix "ghosts" (tablets) via colostomy or in the stool, and that this is of no concern since the active medication has already been absorbed.
    10.Patients should be advised that if they have been receiving treatment with OxyContin for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the OxyContin dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.
    11.Patients should be instructed to keep OxyContin in a secure place out of the reach of children. When OxyContin is no longer needed, the unused tablets should be destroyed by flushing down the toilet.
    Use in Drug and Alcohol Addiction
    OxyContin is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.

    Drug-Drug Interactions
    Opioid analgesics, including OxyContin®, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
    Inhibitors of CYP3A4:
    Since the CYP3A4 isoenzyme plays a major role in the metabolism of oxycodone, co-administration of drugs that inhibit CYP3A4 activity, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations. A published study showed that the co-administration of the antifungal drug, voriconazole, increased oxycodone AUC and Cmax by 3.6 and 1.7 fold, respectively. Although clinical studies have not been conducted with other CYP3A4 inhibitors, the expected clinical results would be increased or prolonged opioid effects. If co-administration with OxyContin is necessary, caution is advised when initiating therapy with, currently taking, or discontinuing CYP450 inhibitors. These patients should be evaluated at frequent intervals and dose adjustments considered until stable drug effects are achieved.
    Inducers of CYP3A4:
    CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone and, therefore, may cause increased clearance of the drug, which could lead to a decrease in oxycodone plasma concentrations, lack of efficacy, or, possibly, development of abstinence syndrome in a patient who had developed physical dependence to oxycodone. A published study showed that the co-administration of rifampin, a drug metabolizing enzyme inducer, decreased oxycodone (oral) AUC and Cmax by 86% and 63%, respectively. If co-administration with OxyContin is necessary, caution is advised when initiating therapy with, currently taking, or discontinuing CYP450 inducers. These patients should be evaluated at frequent intervals and dose adjustments considered until stable drug effects are achieved.
    Inhibitors of CYP2D6:
    Oxycodone is metabolized in part to oxymorphone via cytochrome P450 2D6. While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs including amiodarone and quinidine as well as polycyclic antidepressants), such blockade has not yet been shown to be of clinical significance during oxycodone treatment.

    Use with CNS Depressants
    OxyContin, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, centrally acting anti-emetics, tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma may result. No specific interaction between oxycodone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate.

    Carcinogenesis, Mutagenesis, Impairment of Fertility
    Studies of oxycodone to evaluate its carcinogenic potential have not been conducted.
    Oxycodone was not mutagenic in the following assays: Ames Salmonella and E. coli test with and without metabolic activation at doses of up to 5000 µg, chromosomal aberration test in human lymphocytes in the absence of metabolic activation at doses of up to 1500 µg/mL and with activation 48 hours after exposure at doses of up to 5000 µg/mL, and in the in vivo bone marrow micronucleus test in mice (at plasma levels of up to 48 µg/mL). Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation in the human chromosomal aberration test (at greater than or equal to 1250 µg/mL) at 24 but not 48 hours of exposure and in the mouse lymphoma assay at doses of 50 µg/mL or greater with metabolic activation and at 400 µg/mL or greater without metabolic activation.

    Pregnancy
    Teratogenic Effects - Category B: Reproduction studies have been performed in rats and rabbits by oral administration at doses up to 8 mg/kg and 125 mg/kg, respectively. These doses are 3 and 46 times a human dose of 160 mg/day, based on mg/kg basis. The results did not reveal evidence of harm to the fetus due to oxycodone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

    Labor and Delivery
    OxyContin® is not recommended for use in women during and immediately prior to labor and delivery because oral opioids may cause respiratory depression in the newborn. Neonates whose mothers have been taking oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.

    Nursing Mothers
    Low concentrations of oxycodone have been detected in breast milk. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped. Ordinarily, nursing should not be undertaken while a patient is receiving OxyContin because of the possibility of sedation and/or respiratory depression in the infant.

    Pediatric Use
    Safety and effectiveness of OxyContin have not been established in pediatric patients below the age of 18. It must be remembered that OxyContin Tablets cannot be crushed or divided for administration.

    Geriatric Use
    In controlled pharmacokinetic studies in elderly subjects (greater than 65 years) the clearance of oxycodone appeared to be slightly reduced. Compared to young adults, the plasma concentrations of oxycodone were increased approximately 15% (see PHARMACOKINETICS AND METABOLISM). Of the total number of subjects (445) in clinical studies of OxyContin, 148 (33.3%) were age 65 and older (including those age 75 and older) while 40 (9.0%) were age 75 and older. In clinical trials with appropriate initiation of therapy and dose titration, no untoward or unexpected side effects were seen in the elderly patients who received OxyContin. Thus, the usual doses and dosing intervals are appropriate for these patients. As with all opioids, the starting dose should be reduced to 1/3 to 1/2 of the usual dosage in debilitated, non-tolerant patients. Respiratory depression is the chief hazard in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.

    Laboratory Monitoring
    Due to the broad range of plasma concentrations seen in clinical populations, the varying degrees of pain, and the development of tolerance, plasma oxycodone measurements are usually not helpful in clinical management. Plasma concentrations of the active drug substance may be of value in selected, unusual or complex cases.

    Hepatic Impairment
    A study of OxyContin in patients with hepatic impairment indicates greater plasma concentrations than those with normal function. The initiation of therapy at 1/3 to 1/2 the usual doses and careful dose titration is warranted.

    Renal Impairment
    In patients with renal impairment, as evidenced by decreased creatinine clearance (<60 mL/min), the concentrations of oxycodone in the plasma are approximately 50% higher than in subjects with normal renal function. Dose initiation should follow a conservative approach. Dosages should be adjusted according to the clinical situation.

    Gender Differences
    In pharmacokinetic studies, opioid-naive females demonstrate up to 25% higher average plasma concentrations and greater frequency of typical opioid adverse events than males, even after adjustment for body weight. The clinical relevance of a difference of this magnitude is low for a drug intended for chronic usage at individualized dosages, and there was no male/female difference detected for efficacy or adverse events in clinical trials.

    ADVERSE REACTIONS
    The safety of OxyContin® was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received OxyContin in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day.
    Serious adverse reactions which may be associated with OxyContin Tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock (see OVERDOSAGE).
    The non-serious adverse events seen on initiation of therapy with OxyContin are typical opioid side effects. These events are dose-dependent, and their frequency depends upon the dose, the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia.
    In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid. Many of these adverse events will cease or decrease in intensity as OxyContin therapy is continued and some degree of tolerance is developed.
    Clinical trials comparing OxyContin with immediate-release oxycodone and placebo revealed a similar adverse event profile between OxyContin and immediate-release oxycodone. The most common adverse events (>5%) reported by patients at least once during therapy were:
    TABLE 3 OxyContin
    (n=227) Immediate-Release
    (n=225) Placebo
    (n=45)
    (%) (%) (%)
    Constipation (23) (26) (7)
    Nausea (23) (27) (11)
    Somnolence (23) (24) (4)
    Dizziness (13) (16) (9)
    Pruritus (13) (12) (2)
    Vomiting (12) (14) (7)
    Headache (7) (8) (7)
    Dry Mouth (6) (7) (2)
    Asthenia (6) (7) -
    Sweating (5) (6) (2)
    The following adverse experiences were reported in OxyContin®-treated patients with an incidence between 1% and 5%. In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups.
    The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience.
    Blood and lymphatic system disorders: lymphadenopathy
    Cardiac disorders: palpitations (in the context of withdrawal)
    Ear and labyrinth disorders: tinnitus
    Endocrine disorders: syndrome of inappropriate antidiuretic hormone secretion (SIADH)
    Eye disorders: abnormal vision
    Gastrointestinal disorders: dental caries, dysphagia, eructation, flatulence, gastrointestinal disorder, ileus, increased appetite, stomatitis
    General disorders and administration site conditions: chest pain, edema, facial edema, malaise, pain, peripheral edema, thirst, withdrawal syndrome (with and without seizures)
    Hepatobiliary disorders: cholestasis
    Immune system disorders: anaphylactic or anaphylactoid reaction (symptoms of)
    Infections and infestations: pharyngitis
    Injury, poisoning and procedural complications: accidental injury
    Investigations: hyponatremia, increased hepatic enzymes, ST depression
    Metabolism and nutrition disorders: dehydration
    Musculoskeletal and connective tissue disorders: neck pain
    Nervous system disorders: abnormal gait, amnesia, hyperkinesia, hypertonia (muscular), hypesthesia, hypotonia, migraine, paresthesia, seizures, speech disorder, stupor, syncope, taste perversion, tremor, vertigo
    Psychiatric disorders: agitation, depersonalization, depression, emotional lability, hallucination
    Renal and urinary disorders: dysuria, hematuria, polyuria, urinary retention, urination impaired
    Reproductive system and breast disorders: amenorrhea,decreased libido, impotence
    Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration
    Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis, urticaria
    Vascular disorders: vasodilation

    OVERDOSAGE
    Acute overdosage with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, and death.
    Deaths due to overdose have been reported with abuse and misuse of OxyContin®, by ingesting, inhaling, or injecting the crushed tablets. Review of case reports has indicated that the risk of fatal overdose is further increased when OxyContin is abused concurrently with alcohol or other CNS depressants, including other opioids.
    In the treatment of oxycodone overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
    The pure opioid antagonists such as naloxone or nalmefene are specific antidotes against respiratory depression from opioid overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. In patients who are physically dependent on any opioid agonist including OxyContin, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.

    DOSAGE AND ADMINISTRATION
    General Principles
    OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.
    OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissloved OxyContin® Tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.
    One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).
    Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.
    OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.
    Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

    Initiation of Therapy
    It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:
    (1)
    risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression;
    (2)
    the age, general condition and medical status of the patient;
    (3)
    the daily dose, potency, and kind of the analgesic(s) the patient has been taking;
    (4)
    the reliability of the conversion estimate used to calculate the dose of oxycodone;
    (5)
    the patient's opioid exposure and opioid tolerance (if any);
    (6)
    the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and
    (7)
    the balance between pain control and adverse experiences.
    Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).
    For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.
    Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.
    1.Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone.
    2.When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin.
    3.Round down to a dose which is appropriate for the tablet strengths available.
    4.Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated.
    5.No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy.
    TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. For patients receiving high-dose parenteral opioids, a more conservative conversion is warranted. For example, for high-dose parenteral morphine, use 1.5 instead of 3 as a multiplication factor.
    (Mg/Day Prior Opioid x Factor = Mg/Day Oral
    Oxycodone)
    Oral Prior Opioid Parenteral Prior Opioid
    Oxycodone 1 --
    Codeine 0.15 --
    Hydrocodone 0.9 --
    Hydromorphone 4 20
    Levorphanol 7.5 15
    Meperidine 0.1 0.4
    Methadone 1.5 3
    Morphine 0.5 3
    In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.
    OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

    Conversion from Transdermal Fentanyl to OxyContin
    Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

    Managing Expected Opioid Adverse Experiences
    Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.
    Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.
    Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

    Individualization of Dosage
    Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.
    If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.
    If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.
    During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

    Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)
    OxyContin 60 mg, 80 mg, and 160 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant, or sedating effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
    Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
    One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

    Supplemental Analgesia
    Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

    Maintenance of Therapy
    The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.
    During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

    Cessation of Therapy
    When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

    Conversion from OxyContin to Parenteral Opioids
    To avoid overdose, conservative dose conversion ratios should be followed.

    SAFETY AND HANDLING
    OxyContin Tablets are solid dosage forms that contain oxycodone which is a controlled substance. Like morphine, oxycodone is controlled under Schedule II of the Controlled Substances Act.
    OxyContin has been targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

    HOW SUPPLIED
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets 10 mg are round, unscored, white-colored, convex tablets imprinted with OC on one side and 10 on the other. They are supplied as follows:
    NDC 59011-100-10: child-resistant closure, opaque plastic bottles of 100
    NDC 59011-100-20: unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets 15 mg are round, unscored, gray-colored, convex tablets imprinted with OC on one side and 15 on the other. They are supplied as follows:
    NDC 59011-815-10: child-resistant closure, opaque plastic bottles of 100
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets 20 mg are round, unscored, pink-colored, convex tablets imprinted with OC on one side and 20 on the other. They are supplied as follows:
    NDC 59011-103-10: child-resistant closure, opaque plastic bottles of 100
    NDC 59011-103-20: unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets 30 mg are round, unscored, brown-colored, convex tablets imprinted with OC on one side and 30 on the other. They are supplied as follows:
    NDC 59011-830-10: child-resistant closure, opaque plastic bottles of 100
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets 40 mg are round, unscored, yellow-colored, convex tablets imprinted with OC on one side and 40 on the other. They are supplied as follows:
    NDC 59011-105-10: child-resistant closure, opaque plastic bottles of 100
    NDC 59011-105-20: unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets 60 mg are round, unscored red-colored, convex tablets imprinted with OC on one side and 60 on the other. They are supplied as follows:
    NDC 59011-860-10: child-resistant closure, opaque plastic bottles of 100
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets 80 mg are round, unscored, green-colored, convex tablets imprinted with OC on one side and 80 on the other. They are supplied as follows:
    NDC 59011-107-10: child-resistant closure, opaque plastic bottles of 100
    NDC 59011-107-20: unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton
    OxyContin® (oxycodone hydrochloride controlled-release) Tablets 160 mg are caplet-shaped, unscored, blue-colored, convex tablets imprinted with OC on one side and 160 on the other. They are supplied as follows:
    NDC 59011-109-10: child-resistant closure, opaque plastic bottles of 100
    NDC 59011-109-20: unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton

    Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
    Dispense in tight, light-resistant container.
    Healthcare professionals can telephone Purdue Pharma’s Medical Services Department
    (1-888-726-7535) for information on this product.

    CAUTION
    DEA Order Form Required.
    ©2010 Purdue Pharma L.P.
    Purdue Pharma L.P.
    Stamford, CT 06901-3431
    U.S. Patent Numbers 5,508,042 and 7,129,248
    April 16, 2010
    301371-0D

    PATIENT INFORMATION
    OXYCONTIN® CII
    (Oxycodone HCl Controlled-Release) Tablets
    OxyContin® Tablets, 10 mg
    OxyContin® Tablets, 15 mg
    OxyContin® Tablets, 20 mg
    OxyContin® Tablets, 30 mg
    OxyContin® Tablets, 40 mg
    OxyContin® Tablets, 60 mg
    OxyContin® Tablets, 80 mg
    OxyContin® Tablets, 160 mg
    Read this information carefully before you take OxyContin® (ox-e-CON-tin) tablets. Also read the information you get with your refills. There may be something new. This information does not take the place of talking with your doctor about your medical condition or your treatment. Only you and your doctor can decide if OxyContin is right for you. Share the important information in this leaflet with members of your household.
    What Is The Most Important Information I Should Know About OxyContin®?
    •Use OxyContin the way your doctor tells you to.
    •Use OxyContin only for the condition for which it was prescribed.
    •OxyContin is not for occasional ("as needed") use.
    •Swallow the tablets whole. Do not cut, break, crush, dissolve, or chew them before swallowing. OxyContin® works properly over 12 hours only when swallowed whole. If a tablet is cut, broken, crushed, dissolved, or chewed, the entire 12 hour dose will be absorbed into your body all at once. This can be dangerous, causing an overdose, and possibly death.
    •Keep OxyContin® out of the reach of children. Accidental overdose by a child is dangerous and may result in death.
    •Prevent theft and misuse. OxyContin contains a narcotic painkiller that can be a target for people who abuse prescription medicines. Therefore, keep your tablets in a secure place, to protect them from theft. Never give them to anyone else. Selling or giving away this medicine is dangerous and against the law.
    What is OxyContin®?
    OxyContin® is a tablet that comes in several strengths and contains the medicine oxycodone (ox-e-KOE-done). This medicine is a painkiller like morphine. OxyContin treats moderate to severe pain that is expected to last for an extended period of time. Use OxyContin regularly during treatment. It contains enough medicine to last for up to twelve hours.
    Who Should Not Take OxyContin®?
    Do not take OxyContin® if
    •your doctor did not prescribe OxyContin® for you.
    •your pain is mild or will go away in a few days.
    •your pain can be controlled by occasional use of other painkillers.
    •you have severe asthma or severe lung problems.
    •you have had a severe allergic reaction to codeine, hydrocodone, dihydrocodeine, or oxycodone (such as Tylox, Tylenol with Codeine, or Vicodin). A severe allergic reaction includes a severe rash, hives, breathing problems, or dizziness.
    •you had surgery less than 12 - 24 hours ago and you were not taking OxyContin just before surgery.
    Your doctor should know about all your medical conditions before deciding if OxyContin is right for you and what dose is best. Tell your doctor about all of your medical problems, especially the ones listed below:
    •trouble breathing or lung problems
    •head injury
    •liver or kidney problems
    •adrenal gland problems, such as Addison’s disease
    •convulsions or seizures
    •alcoholism
    •hallucinations or other severe mental problems
    •past or present substance abuse or drug addiction
    If any of these conditions apply to you, and you haven’t told your doctor, then you should tell your doctor before taking OxyContin.
    If you are pregnant or plan to become pregnant, talk with your doctor. OxyContin may not be right for you. Tell your doctor if you are breast-feeding. OxyContin will pass through the milk and may harm the baby.
    Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. They may cause serious medical problems when taken with OxyContin, especially if they cause drowsiness.
    How Should I Take OxyContin®?
    •Follow your doctor’s directions exactly. Your doctor may change your dose based on your reactions to the medicine. Do not change your dose unless your doctor tells you to change it. Do not take OxyContin more often than prescribed.
    •Swallow the tablets whole. Do not cut, break, crush, dissolve, or chew before swallowing. If the tablets are not whole, your body will absorb too much medicine at one time. This can lead to serious problems, including overdose and death.
    •If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once unless your doctor tells you to.
    •In case of overdose, call your local emergency number or Poison Control Center right away.
    •Review your pain regularly with your doctor to determine if you still need OxyContin.
    •You may see tablets in your stools (bowel movements). Do not be concerned. Your body has already absorbed the medicine.
    If you continue to have pain or bothersome side effects, call your doctor.
    Stopping OxyContin. Consult your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms. You should not stop taking OxyContin all at once if you have been taking it for more than a few days.
    After you stop taking OxyContin, flush the unused tablets down the toilet.
    What Should I Avoid While Taking OxyContin®?
    •Do not drive, operate heavy machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. OxyContin can make you sleepy.
    •Do not drink alcohol while using OxyContin. It may increase the chance of getting dangerous side effects.
    •Do not take other medicines without your doctor’s approval. Other medicines include prescription and non-prescription medicines, vitamins, and supplements. Be especially careful about products that make you sleepy.
    What are the Possible Side Effects of OxyContin®?
    Call your doctor or get medical help right away if
    •your breathing slows down
    •you feel faint, dizzy, confused, or have any other unusual symptoms
    Some of the common side effects of OxyContin® are nausea, vomiting, dizziness, drowsiness, constipation, itching, dry mouth, sweating, weakness, and headache. Some of these side effects may decrease with continued use.
    There is a risk of abuse or addiction with narcotic painkillers. If you have abused drugs in the past, you may have a higher chance of developing abuse or addiction again while using OxyContin.
    These are not all the possible side effects of OxyContin. For a complete list, ask your doctor or pharmacist.
    General Advice About OxyContin
    •Do not use OxyContin for conditions for which it was not prescribed.
    •Do not give OxyContin to other people, even if they have the same symptoms you have. Sharing is illegal and may cause severe medical problems, including death.
    This leaflet summarizes the most important information about OxyContin. If you would like more information, talk with your doctor. Also, you can ask your pharmacist or doctor for information about OxyContin that is written for health professionals.
    ©2010 Purdue Pharma L.P.
    Purdue Pharma L.P.
    Stamford, CT 06901-3431
    April 16, 2010
    301371-0D





    Oxycontin, A Good Drug Gone Bad? by admin on: August 19th, 2011

    When it was first approved for sale in 1995, Oxycontin looked to be the ultimate prescription painkiller that contains a synthetic version of morphine. Though it initially seemed a safer drug, ultimately, just like other opiods, it proved to be highly addictive.
    Oxycontin was thought to be ideal for people who could never find real relief for extreme pain. With its time release formulation, Oxycontin can be taken once daily and bring solace to people suffering from chronic conditions like arthritis all day long. The catch, however, is that its users very quickly build up a tolerance to the drug and its euphoric effects. And the withdrawal from Oxcycontin brings symptoms as horrifying as a boat ride on the river Styx, followed by a walk through the flames of Hades.
    The dosing directions for Oxycontin state clearly that the tablets should be taken whole and not crushed, as ingesting the pills in crushed form will give a huge, immediate rush of the drugs’ much sought after euphoric effects. And so, of course, many drug users proceed to crush the pills to reach the high they seek.
    One of the attractions of Oxycontin is that the drug’s “high” comes without obvious signs of intoxication. Users say the high is incredible. So much so, in fact, that many heroin users gravitate to use of the drug because chewing it brings a similar high as heroin, without all the preparation involved. Many of the Oxcycontin tablets initially prescribed for elderly patients seeking pain relief found their way onto the drug black market, where they were crushed and sold for a large profit to addicts.
    Oxcycontin’s manufacturer, Purdue Pharma, has attempted to alter the drug’s formula to reduce the impact of the medication that comes from crushing the tablets. Today the tablets are sold with a strict warning regarding the dangers of addiction to Oxycontin. Whether that warning is actually adhered to by all patients is another story.






























    Comments 61 Comments
    1. mainsail's Avatar
      mainsail -
      Florida has long been the nation's center of the illegal sale of prescription drugs. Doctors here bought 89 percent of all the Oxycodone sold in the country last year. At its peak, so many out-of-staters flocked to Florida to buy drugs at pain clinics that the state earned the nickname "Oxy-Express"But now, with tougher laws, law enforcement has moved aggressively this year to shut down pain clinics; in the past year, more than 400 clinics were either shut down or closed their doors.
    1. mainsail's Avatar
      mainsail -
      Prosecutors have indicted dozens of so-called 'pill mill' operators and nearly 80 doctors have seen their licenses suspended for prescribing mass quantities of pills without clear medical need.New laws are also cutting off distribution. As of July 2011, Florida doctors are barred, with a few exceptions, from dispensing large numbers of narcotics and addictive medicines, like Oxycodone, in their offices or clinics. As a result, doctors' purchases of Oxycodone, which reached 32.2 million doses in the first six months of 2010, fell by 97 percent in the same period this year. The ban was phased in beginning last October, with a limit on the number of pills a doctor could dispense
    1. mainsail's Avatar
      mainsail -
      "We had no tough laws in place; now we do, " said Pam Bondi, Florida's attorney general. Law enforcement agencies are also keeping a closer eye on pharmacies. Now, background checks are required for owners and employees. Violators, whether they are pharmacists, doctors or clinic owners, face stiffer and swifter penalties if they prescribe legal narcotic drugs to people who do not need them or without following required steps.As a result, the price on the street of illegally sold Oxycodone has shot up to $15 per pill, from $8.
    1. mainsail's Avatar
      mainsail -
      Federal, state and local law enforcement officials have worked to increase the number of arrests and major indictments. They are dealing with doctors and clinic operators as they would large criminal enterprises, using racketeering laws.In a rare move, a Florida doctor who worked at a pain clinic was charged with murder by Palm Beach County prosecutors after a patient died of an overdose in 2009, a few hours after the doctor prescribed him 210 pain pills. Charging a doctor and a clinic owner with homicide "was a game changer,' said a Palm beach County sheriff. "You are not going to get a slap on the wrist. You are looking at life in prison."There are still several hundred pain clinics in Florida, with many of them now migrating to central and northern Florida, to cities like Jacksonville, where the crackdown, until recently, has been less intense. In October of this year, the state will start a prescription drug monitoring system that will give pharmacies seven days to record the sales of drugs like Oxycodone.
    1. mainsail's Avatar
      mainsail -
      The current atmosphere is one of aggressive prescription pill crackdowns. What happens if a person who is legally prescribed Oxycodone by a well meaning doctor or pharmacist gets caught selling it on the street? Or if that person happens to take too many pills and dies of an overdose? The police will find out where that person got it from and come down hard on the doctors, pharmacists and pain clinic owners, even if they may have done nothing wrong. Every procedure will be scrutinized. The doctor's judgment will be second guessed. They will be called "drug dealers in white coats" and indicted with racketeering laws.
    1. mainsail's Avatar
      mainsail -
      1. Toothless, inbred zombies wandering South Florida in search of "pain clinics", where oxycodone prescriptions are handed out like Halloween candy. Known pillbilly states consist of: Kentucky, Tennessee, Ohio and West Virginia.Look, there's another truck load of pillbillys from Kentucky pulling into the pain clinic parking lot.
    1. mainsail's Avatar
      mainsail -
      Patient assistance programs (PAPs) are programs created by drug companies, such as PURDUE PHARMA, to offer free or low cost drugs to individuals who are unable to pay for their medication. These Programs may also be called indigent drug programs, charitable drug programs or medication assistance programs. Most of the best known and most prescribed drugs can be found in these programs. All of the major drug companies have patient assistance programs, although every company has different eligibility and application requirements.The PURDUE PHARMA patient assistance program offers free medication to people who otherwise cannot afford their medications. Patients must meet financial and other program specific criteria to be eligible for assistance.
    1. mainsail's Avatar
      mainsail -
      At Purdue, we realize that the cost of prescription medications is one of the most important issues consumers face. We want to help patients obtain appropriate care including the medications prescribed by their healthcare professional.The Purdue Individual Patient Assistance Program provides certain medications at no cost to qualified low-income patients who do not have prescription drug coverage. Eligibility for this program is based on an individual's income in relation to the Federal Poverty Level and other criteria. The program is administered by Express Scripts Specialty Distribution Services, a subsidiary of Express Scripts. Applications to the program must be requested by a patient's prescribing physician using the information below. Contact Information:

      Purdue Patient Assistance ProgramP.O. Box 66547St. Louis, MO 63166-6547(800) 599-6070Hours of Operation:Monday-Friday, 9:00 a.m. to 5:00 p.m. Central Time
    1. mainsail's Avatar
      mainsail -
      The OxyContin Lies

      One of Mahatma Gandhi's largest challenges in getting the British people and government to listen to his demands for the freedom of India was the repeated statements from the British that they were doing good for the Indian people and if they left, then India would be unable to function. Of course, this was untrue and India has proven that it can not only rule itself but also prosper. However, Gandhi needed the weight of world opinion to help force Britain to cede independence to India.He said:An error does not become truth by reason of multiplied propagation, nor does truth become error because nobody sees it. Purdue Pharma and their paid stooges from the “pain organizations” say:
      • Their drug is safer than alternatives (For this lie they paid a $680 million fine and pled guilty to a felony);
      • Only addicts have problems with OxyContin;
      • People who die from OxyContin overdoses did it to themselves;
      • There are many people in pain who need OxyContin;
      • OxyContin treats pain;
      • There are no alternatives to OxyContin.
    1. mainsail's Avatar
      mainsail -
      The TRUTH About OxyContin

      They hope that none of us will see the truth:
      • OxyContin is pharmaceutical grade heroin;
      • OxyContin is just as deadly and addictive as heroin;
      • OxyContin kills even when taken as prescribed;
      • OxyContin makes addicts even when taken as prescribed;
      • OxyContin does not treat pain but acts as an anesthesia and blocks the feelings of pain—the cause of the pain just gets worse.
      • OxyContin can kill if someone not opioid tolerant, takes one pill;
      • OxyContin addiction is creating many new users of heroin because heroin is cheaper;
      • OxyContin competition has forced many heroin dealers to increase their purity of heroin from 20% to 80% so that users could get similar highs and driven down the price of heroin;
      • OxyContin is given out like aspirin by many medical doctors;
      • OxyContin has become the chosen drug for the drug-dealing doctors in “pain mills” that will give a prescription for OxyContin if you have the cash;
      • OxyContin, if banned, could easily be replaced by other drugs.
    1. mainsail's Avatar
      mainsail -
      Shannon is now in a vegetative stateOxyContin is a disgusting and dangerous substance and I fully support and encourage the ban! After reviving my best friend Shannon who died on my floor and is now in a vegetative state 9 months later, reading all this information I find on the internet I'm astonished that OxyContin was ever released. My friend overdosed after being prescribed OxyContin for a broken leg for god sake.... You don't need a drug as powerful as heroin for just a broken bone. Instead of wasting time making and releasing more OxyContin, I'd like someone from the drug company to come and see Shannon in his ward and start working on a treatment for people like Shannon and start correcting the horrible mess that this drug has caused. We all make mistakes but the only way we get past them is by fixing them. Thank God for people like you for setting up this site. God bless you Shannon we miss you brother!!!
    1. mainsail's Avatar
      mainsail -
      My brother went to sleep and never woke up On Sept 18, 2009 I lost my 31 year old brother after he went to sleep and never woke up. A former drug addict he had been clean for many years. About 6 years ago he was in a car accident and had major issues with his back as a result. The drug of choice was OxyContin. Within a year he was a full blown addict and over the past 5 years he spiraled further and further out of control. Upon his death we found not 1, but 5 unfilled prescriptions for this drug along with Roxycontin that had been written by various doctors in his hometown in FL. He died alone in his bed because once again he had fought and gotten violent with his wife who left for the weekend to protect her and his 2 young children. The morning he died his wife returned home and allowed his 3 year daughter to climb on the bed to kiss her father before she left for preschool, not realizing he had been dead for hours. This is not only a crime but a travesty. With enough money and a few complaints anyone can get access to this medicine. How many more have to die before something is done about this?
    1. mainsail's Avatar
      mainsail -
      The drug has an absolute mind of its own I find it very strange when people say "Well, if you take OxyContin properly, you won't get addicted to it." Look, people cannot change their own physiologic make-up. If someone with an injury is prescribed OxyContin, there is a chance that this person is unaware of how addicted to the drug they will mentally and physically become. The drug has an absolute mind of its own. It does not discriminate class, race, intelligence, gender or income. I am guilty of using the drug for illicit reasons. Look, I was at a low point in my life. But I have had a very rough several years fighting the horrid cravings OxyContin causes. Do you think Heroin should be legal for pain patients? If not, then do your homework. Bayer Pharmaceuticals used to manufacture heroin. The same way Purdue Pharmaceuticals manufactures OxyContin. Either come up with a more sophisticated way of distributing OxyContin to the people who need it, create a less addictive form of the drug, or BAN it. Thousands of people are enslaved by it, and just as many have lost their lives because addiction is put entirely on the addict. Yet we let Purdue Pharmaceuticals get away with a fine and a slap on the wrist? Please. This drug is a demon, and has no business being so widely available. Addiction is a disease, not a character flaw.
    1. mainsail's Avatar
      mainsail -
      . Make the choice to stop this madness! This drug should be taken off the market, it has and is taking lives daily. I understand that some people that are using these are doing so non-prescribed, but they and many others that are taking them prescribed are becoming addicted to this powerful nightmare. I have watched personally the pain that it has caused my husband and my family through the powerful addiction!!!! It makes people become someone that they are not. It drives their mind to make desperate decisions because of the power of this horrible drug. I understand that there are people that are in unbearable amounts of pain that this drug keeps them from suffering until their death, but unfortunately not every doctor out there is making the right choice on prescribing it and we can’t control all the doctors in the world, but what we can control is what drugs are on the market, and this is one that SHOULD NOT BE. It is way too addicting and has taken too many lives and destroyed too many families, so please make the choice to stop this madness
    1. mainsail's Avatar
      mainsail -
      I would be happy to testify about my loved one's problems Last week I attended a mental health support group meeting in Ft. Lauderdale, and a member shared the suicide of his sister, who had been a successful attorney, until she'd been in an automobile accident and prescribed OxyContin. He said that his sister's personality since then had been like night and day. Her life so changed, that she gave up in despair and took her own life the week of Christmas, 2009. This is not an isolated story. My own mother became chemically dependent upon OxyContin during the holidays in 2007. I was asked to help transfer her care to pain management. Sadly, another physician has maintained her on OxyContin, despite my stated concerns, and her ongoing mental and physical deterioration. Again, my family's story is not unique. It is time for this drug to be taken off the market. It was designed for end-of-life suffering, not ongoing chronic management of pain. Its addictive qualities are well-documented. Families dealing with addiction and substance abuse, and then having to endure the detox and subsequent personality changes/criminal activity of loved ones should be enough to have this drug taken off the market. For more information, I would be happy to testify about my loved one's ongoing problems and incarceration in Broward County Felony Mental Health Court, for assault with a deadly weapon, drug possession, criminal driving, all while under the influence of OxyContin and its abuse and criminal diversion.
    1. mainsail's Avatar
      mainsail -
      Why is heroin illegal and OxyContin isn't???I work in the pharmacy industry. I have seen firsthand the people and families who have been ruined by OxyContin. These people are not addicts out looking for a fix. These are honest, hardworking people who became ill or got hurt and were prescribed OxyContin by a doctor. It is AMAZINGLY easy for someone to obtain OxyContin from a doctor but when people want to come OFF of the drug the doctors are much less willing to help. I have heard MANY stories of physicians REFUSING to help a patient come off of the drugs that their prescriptions have caused an addiction to. The physicians just want to stop prescribing cold turkey or continue writing scripts. They REFUSE to prescribe Suboxone or aid the patient. This drug is a great pain reliever, I imagine heroin is great at relieving pain as well. Why is heroin illegal and OxyContin isn't??? They seem to have EXACTLY the same effect on people and their lives.
    1. mainsail's Avatar
      mainsail -
      One son is dead, another in prison, because of OxyContinOxyContin is the grim reaper in disguise. My youngest son passed away three years ago relating back to OxyContin, had he not been prescribed Oxy by a doctor, he would not have gotten addicted. Also my other son was prescribed Oxy and he too became addicted and currently is serving time in prison because of this powerful urge to use this drug. Nothing good comes from this pain medicine even when used as it is intended. It takes a person's dignity, then their soul, then their life and when this happens the family slowly dies too. The bad outweighs the good, even doctors aren't spared, no one is safe as long as OxyContin is on the market. I have suffered so much because of OxyContin, during the use of the drug by my sons and the aftermath it has left. Save someone else's child, it is too late for mine.
    1. mainsail's Avatar
      mainsail -
      My cousin overdosed on Oxycontin in July 8, 2005 at age 29. On July 5, 2006, not even one year later my sister died of an Oxycontin overdose at age 21. My brother went to prison for 3 years during December of 2007 at age 31 because of an Oxycontin addiction. My mother took her own life November 6, 2009 (last Thanksgiving) at age 57 because she couldn't handle the loss of her daughter who is also my closest sister. This drug has ripped my family apart causing severe pain and suffering that will never go away. I'm not blind to see the Oxycontin, methadone, and Xanax being prescribed like candy. It's an epidemic that needs to be stopped. I serve our country in the military, and this is how the country serves me
    1. mainsail's Avatar
      mainsail -
      I lost my son, my only child to this "Demon Drug" on 11/22/2009. My son was only 26 years old. He had everything going for himself, 3 successful years of college behind him. Made Dean's List every semester and was only 1 year away from earning his BA in Marketing/Business Management. I fought the battle of Oxy addiction with my son for 5+ plus years. I made a promise to myself that I would never turn my back on my son and to never stop believing in him. This "Demon Drug of the Millennium" is taking the lives of thousands of our youth! How many more young lives must be taken before our government puts a stop to it! ... This is truly an epidemic that is running rampant throughout the United States and other countries as well. I could go on and on about OxyContin, but the bottom line is that I will never see his bright smile, touch his face, feel his big strong arms hug me, or hear my son's voice ever again. I will never see him be the man he wanted to be, graduate from college, marry, living his life happy and successfully, and I will never be able to experience the joy of being a grandmother. What I have to look forward to is living with this big hole inside of me that will never go away, nor can it ever be filled. I am left here to live my life alone and grieve for my son for the rest of my life... Every day I wake up missing him, going to bed every night missing him, I cry for him always. Please use me in anyway necessary in your crusade of trying to ban this "Demon Drug". Respectfully, "A mother mourning the loss of her only son and only child"
    1. mainsail's Avatar
      mainsail -
      Generic Name: PREGABALIN - ORALPronounced: (pree-GAH-ba-lin)Lyrica Oral Uses

      This medication is used to treat pain caused by nerve damage due to diabetes and shingles (herpes zoster) infection. It is also used to treat pain in people with fibromyalgia.It is also used with other medications to treat certain types of seizures (partial onset seizures).Lyrica Oral How To Use

      Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using pregabalin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth, usually twice or three times a day, or as directed by your doctor. You may take it with or without food. When you start this medication, your dosage will probably need to be increased slowly by your doctor to reduce side effects, especially dizziness or drowsiness. Your dosage is based on your medical condition and response to therapy.Use this medication regularly in order to get the most benefit from it. This drug works best when the amount of medicine in your body is kept at a constant level. Therefore it is best to take pregabalin at evenly spaced intervals throughout the day and night.Do not stop taking this drug suddenly without your doctor's approval since seizures may come back, or you may have a withdrawal reaction.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as difficulty sleeping, nausea, headache and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.