OXYCONTIN  - oxycodone hydrochloride tablet 
Lake Erie Medical DBA Quality Care Products LLC

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Oxycontin 80 mg

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

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.


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 analgesic is needed for an extended period of time.

OxyContin is NOT intended for use as a prn analgesic.

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 TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant 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.

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.


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).


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:

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: 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)

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 ADMINISTRATIONGeneral 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 ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED 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 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)the general condition and medical status of the patient;(2)the daily dose, potency, and kind of the analgesic(s) the patient has been taking;(3)the reliability of the conversion estimate used to calculate the dose of oxycodone;(4)the patient's opioid exposure and opioid tolerance (if any);(5)the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (6)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.

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, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only. A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant 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.

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.

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.

©2006, 2007, 2009 Purdue Pharma L.P.

Purdue Pharma L.P.
Stamford, CT 06901-3431

U.S. Patent Numbers 5,508,042 and 7,129,248

September 8, 2009

301371-0C

PATIENT INFORMATIONOXYCONTIN® CII
(Oxycodone HCl Controlled-Release) Tablets

(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®?

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 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:

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®?

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®?

What are the Possible Side Effects of OxyContin®?

Call your doctor or get medical help right away if

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

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.

©2006, 2007, 2009 Purdue Pharma L.P.

* 60 mg, 80 mg, and 160 mg for use in opioid-tolerant patients onlyWARNING:

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

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 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 analgesic is needed for an extended period of time.

OxyContin Tablets are NOT intended for use as a prn analgesic.

OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

OXYCONTIN - oxycodone hydrochloride tablet, film coated, extended release 
Purdue Pharma LP

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MEDICATION GUIDE

OXYCONTIN (ox-e-KON-tin) CII
(oxycodone hydrochloride controlled-release)
Tablets

Read this Medication Guide before you start taking OxyContin and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about OxyContin?

  • OxyContin is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.
  • Prevent theft, misuse and abuse. Keep OxyContin in a safe place, to keep it from being stolen. OxyContin can be a target for people who misuse or abuse prescription medicines or street drugs.
  • Never give OxyContin to anyone else, even if they have the same symptoms you have. It may harm them and even cause death.
  • Before taking OxyContin, tell your doctor if you or a family member have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental illness.

What is OxyContin?

Who should not take OxyContin?

Do not take OxyContin if you:

What should I tell my healthcare provider before taking OxyContin?

OxyContin may not be right for you. Before taking OxyContin, tell your doctor if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sometimes the doses of medicines that you take with OxyContin may need to be changed if used together.

Do not take other medicines without talking to your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you take OxyContin.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist.

How should I take OxyContin?

What should I avoid while taking OxyContin?

What are the possible side effects of OxyContin?

OxyContin can cause serious side effects, including:

The most common side effects of OxyContin include:

Some of these side effects may decrease with continued use. Talk with your healthcare provider if you continue to have these side effects. These are not all the possible side effects of OxyContin. For a complete list, ask your healthcare provider or pharmacist.

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including OxyContin, and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking OxyContin.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.

How should I store OxyContin?

General information about OxyContin
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OxyContin for a condition for which it was not prescribed. Never give your OxyContin to other people even if they have the same symptoms you have.

Selling or giving away OxyContin may harm others, even causing death, and is against the law.

This Medication Guide summarizes the most important information about OxyContin. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about OxyContin that is written for health professionals. For more information about OxyContin, go to www.purduepharma.com or call 1-888-726-7535.


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OXYCONTIN 
oxycodone hydrochloride   tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)49999-857 (59011-107)
Route of AdministrationORALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE80 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIO METHACRYLATE COPOLYMER TYPE A 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 400 
POVIDONE 
SODIUM HYDROXIDE 
SORBIC ACID 
STEARYL ALCOHOL 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
FD&C BLUE NO. 2 
HYDROXYPROPYL CELLULOSE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorgreenScore no score
ShapeROUNDSize11mm
FlavorImprint Code 80;OC
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
149999-857-9090 BOTTLE In 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02055308/28/2010

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIOperations
Purdue Pharmaceuticals LP132080875manufacture
Establishment
NameAddressID/FEIOperations
Lake Erie Medica DBA Quality Care Products LLC831276758repack
Revised: 08/2010Lake Erie Medical DBA Quality Care Products LLC