Generic Revia

NALTREXONE HCI
Tablets: 50 mg (Rx) ReVia (DuPont)

Indications
Narcotic addiction: Blockade of the effects of exogenously administered opioids.
Alcoholism: Treatment of alcohol dependence.

Administration and Dosage
If there is any question of occult opioid dependence, perform a naloxone challenge test. Do not attempt treatment until naloxone challenge is negative. Alcoholism: A dose of 50 mg once daily is recommended for most patients. An initial 25 mg dose, splitting the daily dose and adjusting the time of dosing have met with limited success. Narcotic dependence: Initiate treatment using the following guidelines:
1.) Do not attempt treatment until the patient has remained opioid-free for 7 to 10 days.
2.) Administer a naloxone challenge test. If signs of opioid withdrawal are still observed following challenge, do not treat with naltrexone. The naloxone challenge can be repeated in 24 hours.
3.) Initiate treatment carefully, slowly increasing the dose. Administer 25 mg initially; observe patient for 1 hour. If no withdrawal signs occur, give the rest of the daily dose.
Maintenance treatment: Once the patient has been started on naltrexone, 50 mg every 24 hours will produce adequate clinical blockade of the actions of parenterally administered opioids. A flexible dosing regimen may be employed. Thus, patients may receive 50 mg every weekday with a 100 mg dose on Saturday, 100 mg every other day, or 150 mg every third day. Several studies have employed the following dosing regimen with success: 100 mg Monday, 100 mg Wednesday, and 150 mg Friday.

Actions
Pharmacology: Naltrexone blocks the effects of opioids by competitive binding at opioid receptors. This makes the blockade potentially surmountable.
Pharmacokinetics:
Absorption - Although well absorbed orally, naltrexone is subject to significant first-pass metabolism with oral bioavailability estimates ranging from 5% to 40%. Following oral administration, naltrexone undergoes rapid and nearly complete absorption with about 96% of the dose absorbed from the GI tract. Peak plasma levels of naltrexone and á-3-naltrexol occur Distribution - The volume of distribution for naltrexone after IV administration is estimated to be 1350 L. In vitro, naltrexone is 21% bound to plasma proteins.
Metabolism/Excretion - The major metabolite of naltrexone is 6-B-naltrexol. The activity of naltrexone is believed to be due to both parent and the 6-B-naltrexol metabolite. The mean elimination half-life values for naltrexone and 6-B-naltrexol are 4 and 13 hours, respectively.
Renal elimination is primarily by glomerular filtration. Parent drug and metabolites are excreted primarily by the kidney; however, urinary excretion of unchanged naltrexone accounts for

Contraindications
Patients receiving opioid analgesics; opioid-dependent patients; patients in acute opioid withdrawal; failed naloxone challenge; positive urine screen for opioids; history of sensitivity to naltrexone; acute hepatitis or liver failure.

Warnings
Hepatotoxicity: Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. It is contra indicated 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.
Warn patients of the risk of hepatic injury and advise them to stop naltrexone and seek medical attention if they experience symptoms of acute hepatitis.
Although no cases of hepatic failure have ever been reported, consider this as a possible risk of treatment.
Abstinence precipitation/syndrome: Unintended precipitation of abstinence or exacerbation of a preexisting sub-clinical abstinence syndrome may occur; therefore, patients should remain opioid-free for a minimum of 7 to 10 days before starting naltrexone.
Severe opioid withdrawal syndromes: Severe opioid withdrawal syndromes precipitated by accidental naltrexone ingestion have occurred in opioid-dependent individuals. Withdrawal symptoms usually appear Surmountable blockade: While naltrexone is a potent antagonist with a prolonged pharmacologic effect (24 to 72 hours), the blockade produced by naltrexone is surmountable. This poses a potential risk to individuals who attempt to overcome the blockade by self-administering large amounts of opioids. Any attempt by a patient to overcome the antagonism by taking opioids is very dangerous and may lead to fatal overdose.
Use with narcotics: Patients taking naltrexone may not benefit from opioid-containing medicines. Use a non-opioid-containing alternative, if available.
Pregnancy: Category Ñ
Lactation: It is not known if naltrexone is excreted in breast milk.
Children: Safety for use in children

Precautions
Monitoring: A high index of suspicion for drug-related hepatic injury is critical if the occurrence of liver damage induced by naltrexone is to be detected at the earliest possible time.
Suicide: The risk of suicide is increased in patients with substance abuse with or without concomitant depression. This risk is not abated by treatment with naltrexone.

Drug Interactions
Drugs that may be affected by naltrexone include opioid-containing products and thioridazine.

Adverse Reactions
Adverse reactions associated with treatment of alcoholism include nausea, headache, dizziness, nervousness, fatigue, insomnia, and vomiting.
Reactions associated with treatment of narcotic addiction include difficulty sleeping, anxiety, nervousness, headache, low energy, irritability, increased energy, dizziness, abdominal cramps/pain, nausea, vomiting, loss of appetite, diarrhea, constipation, joint/muscle pain, delayed ejaculation, decreased potency, skin rash, chills, and increased thirst.
GENERAL HEALTH

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