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Oxymorphone hydrochloride

OXYMORPHONE HYDROCHLORIDE

Manufacturer: Amneal Pharmaceuticals LLC

Score: 144.0

Quick Summary

Oxymorphone Hydrochloride is an opioid analgesic used for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is available in 5 mg and 10 mg tablet strengths for oral administration. The drug has a boxed warning for addiction, abuse, and misuse, as well as life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome, and interaction with alcohol. The recommended dosage is 10 to 20 mg every 4 to 6 hours as needed for pain, with a maximum daily dose of 400 mg. Special population considerations include use in pregnancy, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Management of acute pain severe enough to require an opioid analgesic
  • Alternative treatments are inadequate
  • Available in 5 mg and 10 mg tablet strengths for oral administration

Important Safety Information

Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; interaction with alcohol

Contraindications

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity to oxymorphone
  • Moderate or severe hepatic impairment

Adverse Reactions

  • Nausea
  • Pyrexia
  • Somnolence
  • Vomiting
  • Pruritus
  • Headache
  • Dizziness
  • Constipation
  • Confusion

Dosing Recommendations

General Guidance

Use with caution in elderly patients, patients with mild hepatic impairment, and patients with renal impairment

Acute pain

Adult Dose

10 to 20 mg every 4 to 6 hours as needed for pain

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

  • Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
  • Oxymorphone Hydrochloride is not recommended for use in pregnant women during or immediately prior to labor

Nursing Mothers

  • Oxymorphone Hydrochloride is not recommended for use in nursing mothers

Pediatric Use

  • Safety and effectiveness for pediatric patients, 0 to 17 years, have not been established
  • Oxymorphone Hydrochloride is not recommended for use in pediatric patients

Geriatric Use

  • Oxymorphone Hydrochloride should be used with caution in elderly patients
  • Dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range

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