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  • OxyContin
    (Oxycodone HCl) - Purdue Pharma

    BOXED WARNING

    Exposes users to risks of addiction, abuse, and misuse, leading to overdose and death; assess each patient's risk prior to prescribing and monitor regularly for development of these behaviors/conditions. Serious, life-threatening, or fatal respiratory depression may occur; monitor during initiation or following a dose increase. Crushing, dissolving, or chewing tab can cause rapid release and absorption of potentially fatal dose; instruct patients to swallow tab whole. Accidental ingestion, especially by children, can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome; advise pregnant women of the risk and ensure availability of appropriate treatment. Concomitant use of CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in oxycodone overdose; monitor patients receiving concomitant CYP3A4 inhibitors/inducers.

    View FDA-Approved Full Prescribing Information for OxyContin

    THERAPEUTIC CLASS

    Opioid analgesic

    DEA CLASS

    CII

    INDICATIONS

    Management of severe pain that requires daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

    ADULT DOSAGE

    Adults: Initial: First Opioid Analgesic/Nonopioid Tolerant: 10mg q12h. Conversion from Other Oral Oxycodone Formulations: 1/2 of total daily dose q12h. Conversion from Other Opioids: D/C all other around-the-clock opioids when therapy is initiated. Initial: 10mg q12h. Conversion from Transdermal Fentanyl: 10mg q12h for each 25mcg/hr fentanyl transdermal patch; administer dose 18 hrs following removal of patch. Titrate: Individualize dose. May increase total daily dose by 25-50% of current dose every 1-2 days. Hepatic Impairment: Initial: 1/3 to 1/2 the usual starting dose followed by careful dose titration. Renal Impairment: Follow conservative dose initiation and adjust accordingly. Discontinuation: Use gradual downward titration. Elderly: Reduce starting dose to 1/3 to 1/2 the usual dose in debilitated, nonopioid tolerant patients. Refer to PI for further dosage information.

    HOW SUPPLIED

    Tab, Extended-Release: 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg

    CONTRAINDICATIONS

    Significant respiratory depression, acute or severe bronchial asthma in unmonitored settings or in the absence of resuscitative equipment, known or suspected paralytic ileus and GI obstruction.

    WARNINGS/PRECAUTIONS

    Reserve use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for management of chronic pain. 60mg and 80mg tabs, a single dose >40mg, or a total daily dose >80mg are only for use in opioid-tolerant patients. Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. Consider alternative nonopioid analgesics in patients with significant chronic obstructive pulmonary disease (COPD) or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. May cause severe hypotension, orthostatic hypotension, and syncope; increased risk in patients whose ability to maintain BP has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressants. Avoid with circulatory shock. Monitor patients who may be susceptible to intracranial effects of carbon dioxide retention for signs of sedation and respiratory depression when initiating therapy. Therapy may obscure clinical course in patient with head injury. Avoid with impaired consciousness or coma. Difficulty in swallowing tab, intestinal obstruction, and exacerbation of diverticulitis reported; consider alternative analgesic in patients who have difficulty swallowing or have underlying GI disorders that may predispose them to obstruction. May cause spasm of sphincter of Oddi and increase in serum amylase; monitor patients with biliary tract disease. May aggravate convulsions and induce/aggravate seizures. May impair mental or physical abilities. Urine drug test may not detect oxycodone reliably. Not recommended for use immediately prior to labor.

    ADVERSE REACTIONS

    Respiratory depression, constipation, N/V, somnolence, dizziness, pruritus, headache, dry mouth, asthenia, sweating, apnea, respiratory arrest, circulatory depression, hypotension.

    DRUG INTERACTIONS

    See Boxed Warning. Respiratory depression, hypotension, and profound sedation or coma may occur with CNS depressants (eg, sedatives, anxiolytics, neuroleptics); if coadministration is required, consider dose reduction of one or both agents. Monitor use in elderly, cachectic, and debilitated patients when coadministered with other drugs that depress respiration. May enhance neuromuscular blocking action of true skeletal muscle relaxants and increase respiratory depression. CYP3A4 inhibitors (eg, erythromycin, ketoconazole, ritonavir) may increase levels of oxycodone and prolong opioid effects; these effects could be more pronounced with concomitant use of CYP2D6 and 3A4 inhibitors. CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin) may decrease levels and cause lack of efficacy, or development of abstinence syndrome. If coadministration is necessary, use with caution when initiating oxycodone treatment in patients currently taking, or discontinuing CYP3A4 inhibitors/inducers. Mixed agonist/antagonists (eg, pentazocine, nalbuphine, butorphanol) or partial agonist (buprenorphine) may reduce analgesic effect or precipitate withdrawal symptoms; avoid coadministration. May reduce efficacy of diuretics and lead to acute urinary retention. Anticholinergics or other medications with anticholinergic activity may increase risk of urinary retention and/or severe constipation and lead to paralytic ileus.

    PREGNANCY

    Category C, not for use in nursing.

    MECHANISM OF ACTION

    Full opioid agonist; not established. Specific CNS opioid receptors have been identified throughout the brain and spinal cord and are thought to play a role in analgesic effect.

    PHARMACOKINETICS

    Absorption: Oral bioavailability (60-87%). Administration of variable doses resulted in different parameters. Distribution: Vd=2.6L/kg (IV); plasma protein binding (45%); crosses placenta; found in breast milk. Metabolism: Extensive; via CYP3A mediated N-demethylation to noroxycodone and CYP2D6 mediated O-demethylation to oxymorphone; noroxycodone and noroxymorphone (major metabolites). Elimination: Urine; T1/2=4.5 hrs.

    ASSESSMENT

    Assess for abuse/addiction risk, pain intensity, prior opioid therapy, opioid tolerance, respiratory depression, drug hypersensitivity, pregnancy/nursing status, possible drug interactions, or any other conditions where treatment is contraindicated or cautioned.

    MONITORING

    Monitor for respiratory depression (especially within first 24-72 hrs of initiation), hypotension, seizures/convulsions, and other adverse reactions. Monitor BP and serum amylase levels. Routinely monitor for signs of misuse, abuse, and addiction. Periodically reassess the continued need for therapy.

    PATIENT COUNSELING

    Inform that use of drug can result in addiction, abuse, and misuse; instruct not to share with others and to take steps to protect from theft or misuse. Inform patients about risk of respiratory depression. Advise to store securely and dispose unused tabs by flushing down the toilet. Inform female patients of reproductive potential that prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome and instruct to inform physician if pregnant or planning to become pregnant. Inform that potentially serious additive effects may occur when used with CNS depressants, and not to use such drugs unless supervised by healthcare provider. Instruct about proper administration instructions. Inform that drug may cause orthostatic hypotension, syncope, impair the ability to perform potentially hazardous activities; advise to not perform such tasks until they know how they will react to medication. Advise of potential for severe constipation, including management instructions. Advise how to recognize anaphylaxis and when to seek medical attention.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Swallow tab whole; do not crush, dissolve, or chew. Do not pre-soak, lick, or wet tab prior to placing in mouth. Take 1 tab at a time with enough water. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F).