Adult Dosing

Opioid dependence

• Start 25 mg PO x 1; may repeat in 1 hrs if withdrawal does not occur
• Maintenance dose: 50 mg PO qd; alt: 100 mg qod or 150 mg q3 days or 50 mg qd on weekdays and 100 mg on Saturday
• Note: Patient must be opioid free x7-10 days; consider naloxone challenge test if risk of withdrawal suspected

Alcohol dependence

• 50 mg PO qd
• Note:: Patient must be opioid free for 7-10 days; consider naloxone challenge test if risk of withdrawal suspected

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids

• Hypersensitivity to any of the ingredients of the product
• Alcohol use
• Opioid use
• Current opioid dependence
• Acute opioid withdrawal
• Hepatic failure
• Acute hepatitis

• Naltrexone can cause hepatocellular injury in excessive doses; contraindicated if acute hepatitis or hepatic failure. Use with caution if active hepatic disease as margin of separation between safe and hepatotoxic doses appears to be 5 fold or less. Naltrexone does not appear to be hepatotoxic at recommended doses. Warn patients of risk of hepatic injury. Discontinue if acute hepatitis symptoms occur

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; caution advised

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; caution advised
• Acute hepatitis/hepatic failure: Contraindicated

• Overdosage may cause hepatotoxicity. It is contraindicated in acute hepatitis or hepatic failure. Discontinue if acute hepatitis symptoms occur [US Black Box Warning]
• Do not start treatment unless patient has been opioid free for at least 7-10 days to prevent occurrence of an acute abstinence syndrome, or exacerbation of a pre-existing subclinical abstinence syndrome
• Attempt by a patient to overcome the antagonism by taking opioids is very dangerous and may lead to a fatal overdose. Patients should be told of the serious consequences of trying to overcome the opiate blockade
• Apprise patients that they may be more sensitive to lower doses of opioids after naltrexone treatment is discontinued
• In case of question of occult opioid dependence, perform a naloxone challenge test. Do not attempt treatment if signs of opioid withdrawal are still observed following challenge test
• Do not perform naloxone challenge in patients showing clinical signs or symptoms of opioid withdrawal or in patients whose urine contains opioids
• Severe opioid withdrawal syndromes precipitated by accidental ingestion of naltrexone may occur in opioid-dependent individuals. Withdrawal symptoms may appear within 5 minutes and last 48 hrs
• Monitor LFTs at baseline and periodically during therapy

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• History of depression
• Suicidal ideation

Pregnancy Category:C

Breastfeeding: Limited data indicates that naltrexone is minimally excreted in breastmilk. If naltrexone is required by the mother, breastfeeding is permissible. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 6 June 2011). According to manufacturer data, as many drugs are excreted in human milk, caution should be exercised when naltrexone is administered to a nursing woman.

• CV: Anxiety, fatigue, headache, insomnia, nervousness, depression, dizziness, increased energy, sedation, suicidal ideation, depression, withdrawal syndrome, insomnia, anxiety, somnolence
• EENT: Hoarseness, runny/stuffy nose, sinus problems, sneezing
• RESP: Cough
• CV: Palpitations
• GI: Hepatotoxicity, abdominal cramps/pain, nausea, constipation, decreased appetite, diarrhea, vomiting, constipation, hepatic impairment
• GU: Delayed ejaculation, decreased potency
• DERM: Skin rash
• HYPERSENSITIVITY: Hypersensitivity reactions
• MUSC: Muscle-joint pain, muscle aches
• MISC: Chills, increased thirst

• Opioid antagonist; competitively blocks the effects of opioids
• Rapidly absorbed following oral administration; undergoes significant first pass metabolism
• Metabolized by liver
• Renally excreted: 53-79% (<2% unchanged); minimally in feces
• Half-life: 4 hrs (naltrexone); 13 hrs (beta-naltrexol)

US Trade Name(s)

• ReVia

US Availability

naltrexone (generic)

• TABS: 50 mg

ReVia

• TABS: 50 mg

Canadian Trade Name(s)

• ReVia

Canadian Availability

ReVia

• TABS: 50 mg

UK Trade Name(s)

• Nalorex
• Opizone

UK Availability

Nalorex, Opizone

• TABS: 50 mg

Australian Trade Name(s)

• ReVia

Australian Availability

naltrexone (generic)

• TABS: 50 mg

ReVia

• TABS: 50 mg

[Outline]

Psychiatric

Alcohol Dependence Drugs

Opioid Antagonists

Pricing data from www.DrugStore.com in U.S.A.

• ReVia 50 MG TABS [Bottle] (TEVA/WOMENS HEALTH)
  30 mg = $275.32
  90 mg = $794.22

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Naltrexone 50 MG Oral Tablet

Ingredient(s): Naltrexone

Imprint: b;50/902

Color(s): White

Shape: Round

Size (mm): 10.00

Score: 2

Inactive Ingredient(s): colloidal silicon dioxide / crospovidone / hydroxypropyl methylcellulose / lactose monohydrate / magnesium stearate / microcrystalline cellulose / polyethylene glycol / polysorbate 80 / synthetic red iron oxide / synthetic yellow iron oxide / titanium dioxide

Drug Label Author:
BARR LABORATORIES, INC.

DEA Schedule:
Non-Scheduled

Drug Name: Naltrexone 50 MG Oral Tablet

Ingredient(s): Naltrexone

Imprint: 5;0;1170

Color(s): Yellow

Shape: Oval

Size (mm): 13.00

Score: 2

Inactive Ingredient(s): crospovidone / hypromellose / lactose monohydrate / magnesium stearate / cellulose, microcrystalline / polyethylene glycol / polysorbate 80 / silicon dioxide / titanium dioxide / ferric oxide yellow / ferric oxide red

Drug Label Author:
Mallinckrodt Inc.

DEA Schedule:
Non-Scheduled