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ROXICODONE
Narcotic analgesics
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Drug Name:

ROXICODONE CII

Generic Name and Formulations:
Oxycodone HCl 5mg, 15mg, 30mg; scored tabs.

Company:
Mallinckrodt, Inc.

Therapeutic Use:

Indications for ROXICODONE:

Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations Of use:

Reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics or opioid combination products) have not been tolerated, are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Adult:

Use lowest effective dose for shortest duration. Individualize. ≥18yrs: Opioid-naïve: initially 5–15mg every 4–6 hours as needed. Renal or hepatic impairment: initiate at lower dose; monitor. Conversion to/from other opioids or combination products: see full labeling. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually by 25–50% every 2–4 days.

Children:

<18yrs: not established.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Warnings/Precautions:

Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug or alcohol abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants.

Interactions:

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs (eg, phenelzine, tranylcypromine, linezolid): not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue Roxicodone if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 and CYP2D6 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.

Pharmacological Class:

Opioid agonist.

Adverse Reactions:

Nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, somnolence; respiratory depression, severe hypotension, syncope.

Generic Availability:

YES

How Supplied:

Tabs—100

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