ROXYBOND Dosage & Rx Info | Uses, Side Effects

Roxybond Generic Name & Formulations

Legal Class

CII

General Description

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

Pharmacological Class

Opioid agonist.

How Supplied

Tabs—100

Manufacturer

Protega Pharmaceuticals LLC

Generic Availability

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. The precise mechanism of the analgesic action is unknown. However, 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.

Roxybond 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.

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

Serious and life-threatening risks from use of Roxybond: 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.

Roxybond Warnings/Precautions

Warnings/Precautions

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

Roxybond Pharmacokinetics

Distribution

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

Metabolism

Hepatic (CYP3A4).

Elimination

Renal. Half-life: 3.8–4.3 hours.

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, orthostatic hypotension, syncope, OIH and allodynia.

Roxybond Clinical Trials

See Literature

Roxybond Note

Not Applicable

Roxybond Patient Counseling