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  • OxyContin
    (Oxycodone HCl) - Purdue Pharma

    BOXED WARNING

    Contains oxycodone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit; assess each patient's risk for opioid abuse or addiction prior to prescribing. Routinely monitor for signs of misuse, abuse, and addiction. Respiratory depression, including fatal cases, may occur even when used as recommended; proper dosing and titration are essential. Should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation or following a dose increase. Swallow tab intact; crushing, dissolving, or chewing tab may cause rapid release and absorption of potentially fatal dose. Accidental ingestion, especially in children, can result in a fatal overdose.

    View FDA-Approved Full Prescribing Information for OxyContin

    THERAPEUTIC CLASS

    Opioid analgesic

    DEA CLASS

    CII

    INDICATIONS

    Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period.

    ADULT DOSAGE

    Adults: Initial: First Opioid Analgesic: 10mg q12h. Conversion from Other Oral Oxycodone: 1/2 of total daily dose q12h. Conversion from Other Opioids: Begin with 1/2 of the estimated daily requirement, then divide into 2 doses taken 12 hrs apart; provide rescue medication (eg, immediate-release oxycodone) to manage inadequate analgesia. Conversion from Transdermal Fentanyl: 10mg q12h for each 25mcg/hr fentanyl transdermal patch 18 hrs following removal of patch. Titrate: May increase total daily dose by 25-50% of current dose every 1-2 days, or each time an increase is clinically indicated. Hepatic Impairment: Start at 1/3 to 1/2 the usual starting dose followed by careful dose titration. Renal Impairment: Follow conservative dose initiation and adjust accordingly. Discontinuation: Gradual downward titration; avoid abrupt discontinuation.

    HOW SUPPLIED

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

    CONTRAINDICATIONS

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

    WARNINGS/PRECAUTIONS

    Not for use as PRN analgesic, for acute or mild pain, pain not expected to persist for an extended period, pain in immediate postoperative period (first 24 hrs following surgery) for patients not previously taking the drug, and postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or postoperative pain is expected to be moderate to severe and persist for an extended period. 60mg and 80mg tabs, a single dose >40mg, or a total daily dose >80mg are only for use in opioid-tolerant patients. 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 patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. May cause severe hypotension, including orthostatic hypotension and syncope, in ambulatory patients; monitor for signs of hypotension after dose initiation or titration. Avoid with circulatory shock. Monitor for signs of sedation and respiratory depression in patients susceptible to the intracranial effects of carbon dioxide retention (eg, those with increased intracranial pressure [ICP] or brain tumors). 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 are at risk for underlying GI disorders resulting in small GI lumen. May cause spasm of sphincter of Oddi and increase in serum amylase; monitor for worsening of symptoms in patients with biliary tract disease (eg, acute pancreatitis). May aggravate convulsions with convulsive disorders and may induce or aggravate seizures in some clinical settings. May impair mental or physical abilities. Not recommended for use immediately prior to and during labor.

    ADVERSE REACTIONS

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

    DRUG INTERACTIONS

    Respiratory depression, hypotension, and profound sedation or coma may occur with other CNS depressants (eg, tranquilizers, general anesthetics, alcohol); when combination is contemplated, start oxycodone at 1/3 to 1/2 the usual dose and use lower dose of the concomitant CNS depressant. May enhance neuromuscular blocking action of true skeletal muscle relaxants and increase respiratory depression. CYP3A4 inhibitors, such as macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), and protease inhibitors (eg, ritonavir) may increase levels of oxycodone, prolonging opioid effects. Decreased levels with CYP450 inducers (eg, rifampin, carbamazepine, phenytoin). CYP2D6 inhibitors (eg, quinidine, fluoxetine) may block the partial metabolism to oxymorphone. Mixed agonist/antagonist analgesics (eg, pentazocine, nalbuphine, butorphanol) may reduce analgesic effect and/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 B, not for use in nursing.

    MECHANISM OF ACTION

    Pure µ-receptor 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: 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: Extensively via CYP3A and 2D6 into noroxycodone (major metabolite), noroxymorphone (active major metabolite), and oxymorphone (active metabolite). Elimination: Urine; T1/2=4.5 hrs.

    ASSESSMENT

    Assess for risk factors for drug abuse or addiction, pain type/severity, prior opioid therapy, opioid tolerance, respiratory depression, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, asthma, GI obstruction, renal/hepatic impairment, pregnancy/nursing status, possible drug interactions, or any other conditions where treatment is contraindicated or cautioned.

    MONITORING

    Monitor for respiratory depression, sedation, CNS depression, aggravation/induction of seizures/convulsions, increase in ICP, hypotension/syncope, symptoms of worsening biliary tract disease, tolerance, physical dependence, and other adverse reactions. Monitor BP and serum amylase levels. Routinely monitor for signs of misuse, abuse, and addiction.

    PATIENT COUNSELING

    Inform that the drug has potential for abuse; instruct not to share with others and to take steps to protect from theft or misuse. Discuss the risk of respiratory depression. Inform that accidental exposure may result in serious harm or death; advise to store securely and dispose unused tabs by flushing down the toilet. Inform that the concomitant use of alcohol can increase the risk of life-threatening respiratory depression. Instruct to not consume alcoholic beverages, or take prescription and OTC products that contain alcohol, during treatment. Inform that drug may cause orthostatic hypotension and syncope. Inform that drug may 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. Instruct to inform physician if pregnant or planning to become pregnant.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Swallow tab intact; do not cut, 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).