Oxymorphone Hydrochloride is indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate, and alternative treatments are inadequate.

Pain

• Initiation of Therapy for Opioid-Naïve and Non-Tolerant Patients:

  • Begin with 5 mg tablets administered orally every 12 hours. 

• Conversion from Another Opioid:

  • When switching from another opioid, utilize available conversion factors to estimate the appropriate dose for Oxymorphone Hydrochloride Extended-Release Tablets. 

• Dose Adjustment and Titration:

  • Adjust the dose at intervals of 3 to 7 days.
  • Increase the dosage in increments of 5 to 10 mg every 12 hours (equivalent to 10 to 20 mg per day).

• Administration Instructions:

  • Administer the tablets on an empty stomach, at least 1 hour before or 2 hours after a meal.
  • Take each Oxymorphone Hydrochloride Extended-Release Tablet one at a time, ensuring complete swallowing with an adequate amount of water immediately after placing it in the mouth.

• Discontinuation in Physically Dependent Patients:

  • Avoid abrupt discontinuation of Oxymorphone Hydrochloride Extended-Release Tablets in physically dependent patients. 

• Swallowing Instructions:

  • Instruct patients to swallow Oxymorphone Hydrochloride Extended-Release Tablets intact.

• Dose Adjustment for Hepatic and Renal Impairment:
  • Reduce the dose of Oxymorphone Hydrochloride Extended-Release Tablets in patients with mild hepatic impairment and those with renal impairment.

Common adverse reactions associated with Oxymorphone Hydrochloride may include:

• Constipation
• Nausea
• Somnolence
• Dizziness
• Vomiting
• Pruritus
• Headache
• Dry mouth
• Sweating

Constipation

Nausea

Somnolence

Dry Mouth

1. Interaction with CNS Depressants:

   • Concomitant use with other central nervous system (CNS) depressants may lead to profound sedation, respiratory depression, and potential fatal outcomes.
   • Consider dose reduction for either or both drugs due to additive pharmacological effects.

2. Elderly, Cachectic, and Debilitated Patients, and Those with Chronic Pulmonary Disease:

   • Monitor this patient population closely due to an elevated risk of life-threatening respiratory depression.
   • Exercise caution and vigilance in managing these patients. 

3. Hypotensive Effect:

   • Monitor patients for hypotensive effects during the initiation and titration of the dosage. 

4. Patients with Head Injury or Increased Intracranial Pressure:

   • Monitor patients with head injury or heightened intracranial pressure for sedation and respiratory depression.
   • Avoid the use of Oxymorphone Hydrochloride Extended-Release Tablets in patients with impaired consciousness or those in a coma susceptible to intracranial effects related to CO2 retention. 

5. Difficulty in Swallowing or Underlying GI Disorders:

   • Exercise caution when using Oxymorphone Hydrochloride Extended-Release Tablets in patients who have difficulty swallowing or possess underlying gastrointestinal disorders that may predispose them to obstruction.