Roxybond

— THERAPEUTIC CATEGORIES —
  • Narcotic analgesics

Roxybond Generic Name & Formulations

General Description

Oxycodone HCl 5mg, 15mg, 30mg; tabs.

Pharmacological Class

Opioid agonist.

How Supplied

Tabs—100

Generic Availability

NO

Roxybond Indications

Indications

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 non-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.

Roxybond 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 evaluated.

Roxybond Contraindications

Contraindications

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

Roxybond Boxed Warnings

Boxed Warning

Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Risks from concomitant use with benzodiazepines or other CNS depressants.

Roxybond Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). 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). 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. 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

Roxybond Pharmacokinetics

See Literature

Roxybond 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. 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 RoxyBond 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.

Roxybond Adverse Reactions

Adverse Reactions

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

Roxybond Clinical Trials

See Literature

Roxybond Note

Not Applicable

Roxybond Patient Counseling

See Literature