• Management of opioid dependence.
• Management of alcohol dependence.

Contraindicated in:

• Hypersensitivity
• Concurrent use of opioid analgesics or physiologic opioid dependence
• Acute opioid withdrawal
• Positive urine screen for opioids
• Failure of a naloxone challenge test

Use Cautiously in:

• History of hepatic impairment/damage
• Moderate to severe renal impairment
• History of depression or suicidal behavior/attempt
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children.

CV: palpitations.

Derm: skin rash.

EENT: hoarseness, runny/stuffy nose, sinus problems, sneezing.

GI: HEPATOTOXICITY, abdominal cramps/pain, nausea, constipation, ↓ appetite, diarrhea, vomiting.

GU: delayed ejaculation, erectile dysfunction.

Hemat: eosinophilia, thrombocytopenia.

Local: injection site reactions.

MS: muscle/joint pain.

Neuro: SUICIDAL IDEATION, anxiety, fatigue, headache, insomnia, nervousness, depression, dizziness, ↑ energy, sedation.

Resp: EOSINOPHILIC PNEUMONIA (INJECTION), cough.

Misc: chills, ↑ thirst.

Drug-Drug:

• Concurrent use with thioridazine may ↑ CNS depression.
• May prevent therapeutic effects of opioid analgesics, antidiarrheals, and antitussives.

(Generic available)

• Tablets: 50 mg;
• Suspension for injection: 380 mg/vial;

Opioid Dependence

• PO (Adults): Following a negative naloxone challenge and 7–10 days of opioid abstinence (longer for methadone), initial dose is 25 mg. If opioid withdrawal does not occur within 1 hr, additional 25 may be given. Maintenance dose is 50 mg daily as a single dose or 50 mg once daily on weekdays and 100 mg on Saturday or 100 mg every other day or 150 mg every third day or 100 mg on Monday and Wednesday and 150 mg on Friday.
• IM (Adults): 380 mg every 4 wk or once monthly.

Alcohol Dependence

• PO (Adults): 50 mg daily as a single dose or 50 mg once daily on weekdays and 100 mg on Saturday or 100 mg every other day or 150 mg every third day or 100 mg on Monday and Wednesday and 150 mg on Friday.
• IM (Adults): 380 mg every 4 wk or once monthly.

naltrexone (Injection): Vivitrol

• Competitively blocks the effects of opioids, including CNS and respiratory depression, without producing any agonist (opioid-like) effects.
• Mechanism in managing alcohol dependence may involve the endogenous opioid system.

• Blocks the effects of opioids in previously dependent patients.
• Reduced alcohol-dependent behavior.

Therapeutic Classification: alcohol abuse therapy adjuncts

Pharmacologic Classification: opioid antagonists

Absorption: Well absorbed orally, but undergoes extensive first pass hepatic metabolism resulting in 5–40% bioavailability. Well absorbed following IM administration.

Distribution: Enters breast milk.

Metabolism/Excretion: Extensively metabolized by the liver. Major metabolite (6–beta-naltrexol) has opioid antagonist activity. Metabolites are excreted in urine.

Half-life: Oral: Naltrexone — 4 hr; 6–beta-naltrexol — 13 hr; IM: Naltrexone — 5–10 days; 6–beta-naltrexol — 5–10 days.

ReVia

(opioid blockade)

†Determined by blockade of effects of 25 mg heroin IV.

• Instruct patient to take naltrexone as directed. Inform patients that there are potentially serious consequences and possibly death if they try to overcome the effects of naltrexone with higher doses of opioids.
• May cause dizziness. Advise patient to avoid driving and other activities requiring alertness until effects of the medication are known.
• Encourage patient and family to be alert for emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania, worsening of depression and suicidal ideation, especially during early antidepressant therapy. Assess symptoms on a day-to-day basis as changes may be abrupt. If these symptoms occur, notify health care professional.
• Inform patient of the risk of hepatic injury. Advise patient to notify health care professional if signs of acute hepatitis (abdominal pain lasting more than a few days, white bowel movements, dark urine, or yellowing of eyes) occur; naltrexone should be discontinued.
• Advise patient and family that patient may be more sensitive to lower doses of opioids after naltrexone treatment stops, when next dose is due, and if a dose is missed. Advise patients that they will not perceive any effects of small doses of opioids and may not experience the same effects from opioid-containing analgesics, antidiarrheals, or antitussives. May lead to overdose including serious injury, coma, or death.
• Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose. Inform patients and caregivers about various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (by prescription, directly from a pharmacist, or as part of a community-based program).
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Advise patient to carry identification to alert medical personnel of naltrexone therapy.
• IM: May cause injection site reactions (cellulitis, induration, hematoma, abscess, sterile abscess, necrosis). Advise patient to monitor injection site and notify health care professional if pain, swelling, tenderness, induration, bruising, pruritus or redness at the injection site occurs and does not improve or worsens within 2 wk. Promptly refer patients with worsening injection site reactions to a surgeon.

nal-TREX-one

NDC Code^*

• 0406- SpecGx LLC
  • 0406-1170- NALTREXONE HYDROCHLORIDE
    • 0406-1170-01- 100 TABLET, FILM COATED in 1 BOTTLE (0406-1170-01)

• 0406- SpecGx LLC
  • 0406-1170- NALTREXONE HYDROCHLORIDE
    • 0406-1170-03- 30 TABLET, FILM COATED in 1 BOTTLE (0406-1170-03)

• 16729- Accord Healthcare, Inc.
  • 16729-081- Naltrexone Hydrochloride
    • 16729-081-01- 100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01)

• 16729- Accord Healthcare, Inc.
  • 16729-081- Naltrexone Hydrochloride
    • 16729-081-10- 30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10)

• 42291- AvKARE, Inc.
  • 42291-632- Naltrexone Hydrochloride
    • 42291-632-30- 30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-326- NALTREXONE HYDROCHLORIDE
    • 47335-326-08- 100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-326- NALTREXONE HYDROCHLORIDE
    • 47335-326-18- 1000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-326- NALTREXONE HYDROCHLORIDE
    • 47335-326-83- 30 TABLET, FILM COATED in 1 BOTTLE (47335-326-83)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-326- NALTREXONE HYDROCHLORIDE
    • 47335-326-88- 100 TABLET, FILM COATED in 1 BOTTLE (47335-326-88)

• 50090- A-S Medication Solutions
  • 50090-2866- Naltrexone Hydrochloride
    • 50090-2866-0- 30 TABLET, FILM COATED in 1 BOTTLE (50090-2866-0)

• 50090- A-S Medication Solutions
  • 50090-3929- NALTREXONE HYDROCHLORIDE
    • 50090-3929-0- 30 TABLET, FILM COATED in 1 BOTTLE (50090-3929-0)

• 51224- TAGI Pharma Inc.
  • 51224-206- Naltrexone Hydrochloride
    • 51224-206-30- 30 TABLET, FILM COATED in 1 BOTTLE (51224-206-30)

• 51224- TAGI Pharma Inc.
  • 51224-206- Naltrexone Hydrochloride
    • 51224-206-50- 100 TABLET, FILM COATED in 1 BOTTLE (51224-206-50)

• 53217- Aidarex Pharmaceuticals LLC
  • 53217-261- Naltrexone Hydrochloride
    • 53217-261-30- 30 TABLET, FILM COATED in 1 BOTTLE (53217-261-30)

• 63629- Bryant Ranch Prepack
  • 63629-1046- Naltrexone Hydrochloride
    • 63629-1046-1- 30 TABLET, FILM COATED in 1 BOTTLE (63629-1046-1)

• 63629- Bryant Ranch Prepack
  • 63629-1047- Naltrexone Hydrochloride
    • 63629-1047-1- 100 TABLET, FILM COATED in 1 BOTTLE (63629-1047-1)

• 65757- Alkermes, Inc.
  • 65757-300- VIVITROL
    • 65757-300-01- 1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03)

• 68071- NuCare Pharmaceuticls, Inc.
  • 68071-2156- Naltrexone Hydrochloride
    • 68071-2156-3- 30 TABLET, FILM COATED in 1 BOTTLE (68071-2156-3)

• 68084- American Health Packaging
  • 68084-291- NALTREXONE HYDROCHLORIDE
    • 68084-291-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-291-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-291-11)

• 68094- Precision Dose Inc.
  • 68094-853- Naltrexone Hydrochloride
    • 68094-853-62- 3 BLISTER PACK in 1 CARTON (68094-853-62) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• 68788- Preferred Pharmaceuticals Inc.
  • 68788-7084- Naltrexone Hydrochloride
    • 68788-7084-1- 100 TABLET, FILM COATED in 1 BOTTLE (68788-7084-1)

• 68788- Preferred Pharmaceuticals Inc.
  • 68788-7084- Naltrexone Hydrochloride
    • 68788-7084-2- 20 TABLET, FILM COATED in 1 BOTTLE (68788-7084-2)

• 68788- Preferred Pharmaceuticals Inc.
  • 68788-7084- Naltrexone Hydrochloride
    • 68788-7084-3- 30 TABLET, FILM COATED in 1 BOTTLE (68788-7084-3)

• 68788- Preferred Pharmaceuticals Inc.
  • 68788-7084- Naltrexone Hydrochloride
    • 68788-7084-6- 60 TABLET, FILM COATED in 1 BOTTLE (68788-7084-6)

• 68788- Preferred Pharmaceuticals Inc.
  • 68788-7084- Naltrexone Hydrochloride
    • 68788-7084-9- 90 TABLET, FILM COATED in 1 BOTTLE (68788-7084-9)

• 69364- Complete Pharmacy and Medical Solutions
  • 69364-3143- Naltrexone
    • 69364-3143-6- 6 BLISTER PACK in 1 BOX (69364-3143-6) > 1 IMPLANT in 1 BLISTER PACK

• 70518- REMEDYREPACK INC.
  • 70518-1146- Naltrexone Hydrochloride
    • 70518-1146-0- 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1146-0)

• 70518- REMEDYREPACK INC.
  • 70518-1312- NALTREXONE HYDROCHLORIDE
    • 70518-1312-0- 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1312-0)

• 71335- Bryant Ranch Prepack
  • 71335-0014- Naltrexone Hydrochloride
    • 71335-0014-1- 30 TABLET, FILM COATED in 1 BOTTLE (71335-0014-1)

• 71335- Bryant Ranch Prepack
  • 71335-0014- Naltrexone Hydrochloride
    • 71335-0014-2- 90 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2)

• 71335- Bryant Ranch Prepack
  • 71335-0014- Naltrexone Hydrochloride
    • 71335-0014-3- 60 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3)

• 71335- Bryant Ranch Prepack
  • 71335-0014- Naltrexone Hydrochloride
    • 71335-0014-4- 45 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4)

• 71335- Bryant Ranch Prepack
  • 71335-0014- Naltrexone Hydrochloride
    • 71335-0014-5- 120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5)

• 71335- Bryant Ranch Prepack
  • 71335-0014- Naltrexone Hydrochloride
    • 71335-0014-6- 15 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6)

• 76519- H.J. Harkins Company Inc.
  • 76519-1160- NALTREXONE HYDROCHLORIDE
    • 76519-1160-5- 15 TABLET, FILM COATED in 1 CONTAINER (76519-1160-5)