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Naltrexone HCl Tablets, USP 50 mg

INDICATION AND USAGE

Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.

IMPORTANT RISK INFORMATION

WARNING: Hepatotoxicity

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis.

CONTRAINDICATIONS

  • Naltrexone is contraindicated in:
    • Patients receiving opioid analgesics.
    • Patients currently dependent on opioids or opiate agonists.
    • Patients in acute opioid withdrawal.
    • Patients who have failed the naloxone challenge test or who have a positive urine screen for opioids.
    • Any individual with a history of sensitivity to naltrexone or any other components of this product.
    • Any individual with acute hepatitis or liver failure.

WARNINGS AND PRECAUTIONS

  • To prevent occurrence of an acute abstinence syndrome, patients must be opioid-free for a minimum of 7 to 10 days before starting naltrexone.
  • Patients should be told of the serious consequences of trying to overcome the opiate blockade.
  • Severe opioid withdrawal syndromes precipitated by the accidental ingestion of naltrexone have been reported in opioid-dependent individuals.

ADVERSE REACTIONS

  • Serious adverse reactions may include liver failure
  • Common adverse reactions include Difficulty sleeping, anxiety, nervousness, abdominal pain/cramps, nausea and/or vomiting, low energy, joint and muscle pain, and headache.

USE IN SPECIFIC POPULATIONS

  • Caution should be exercised when naltrexone hydrochloride is administered to patients with liver disease or renal impairment.
  • The safe use of naltrexone in pediatric patients younger than 18 years old has not been established.

Description Yellow, Film Coated Capsule-Shaped Tablet
Dosage Strength 50 mg
Compares To Revia™
Identification Code Debossed with a number "50" and a full bisect in between the 5 and 0 on one side and "1170" on the other side
Rating AB

Order Information

NDC # Package Size Case Quantity
0406-1170-01 100's 6
0406-1170-03 30's 6

For additional information on Naltrexone HCl Tablets, USP 50 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

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