ROXICODONE Dosage & Rx Info | Uses, Side Effects

Roxicodone Generic Name & Formulations

Legal Class

CII

General Description

Oxycodone HCl 15mg, 30mg; scored tabs.

Pharmacological Class

Opioid agonist.

How Supplied

Tabs—100

Manufacturer

Mallinckrodt, Inc.

Generic Availability

YES

Mechanism of Action

Oxycodone is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Although the precise mechanism of the analgesic action is unknown, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Roxicodone Indications

Indications

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

Limitations of Use

Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration), reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics, opioid combination products) are not tolerated or inadequate to provide analgesia. Should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Roxicodone Dosage and Administration

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 (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.

Children

<18yrs: not established.

Roxicodone Contraindications

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.

Roxicodone Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Roxicodone: Addiction, abuse, and misuse. Life-threatening respiratory depression. Accidental ingestion. Risks from concomitant use with benzodiazepines or other CNS depressants. Neonatal opioid withdrawal syndrome. Opioid analgesic risk evaluation and mitigation strategy (REMS). Cytochrome P450 3A4 interaction.

Roxicodone Warnings/Precautions

Warnings/Precautions

Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression esp. during initiation or following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. 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.

REMS

YES

Roxicodone Pharmacokinetics

Distribution

Volume of distribution (after IV admin): 2.6 L/kg. Plasma protein bound: ~45%.

Metabolism

Hepatic (CYP3A4).

Elimination

Renal. Half-life: 3.5–4 hours. Clearance: 0.8 L/min (adults).

Roxicodone Interactions

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 closely; consider prescribing naloxone if concomitant use is warranted. 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, cyclobenzaprine, metaxalone, 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/or 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.

Roxicodone Adverse Reactions

Adverse Reactions

Nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, somnolence; respiratory depression, orthostatic hypotension, syncope, OIH and allodynia.

Roxicodone Clinical Trials

See Literature

Roxicodone Note

Not Applicable

Roxicodone Patient Counseling