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Vivitrol
naltrexone
Adult Dosing .
Dosage forms: INJ: 95 mg per mL
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene) in patients with opioid use disorder
alcohol use disorder
- [380 mg IM q4wk]
- Info: must be opioid free x7-14 days before tx start; consider naloxone challenge test if risk of withdrawal suspected; D/C tx 1mo before surgery with anticipated opioid use
opioid use disorder
- [380 mg IM q4wk]
- Info: for prevention of relapse following opioid detoxification; must be opioid free x7-14 days before tx start; consider naloxone challenge test if risk of withdrawal suspected; D/C tx 1mo before surgery with anticipated opioid use
renal dosing
- [see below]
- CrCl 50-80: no adjustment; CrCl <50: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: INJ: 95 mg per mL
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene) in patients with opioid use disorder
opioid use disorder (off-label)
- [adolescents]
- Dose: 380 mg IM q4wk; Info: for prevention of relapse following opioid detoxification; must be opioid free x7-14 days before tx start; consider naloxone challenge test if risk of withdrawal suspected; D/C tx 1mo before surgery with anticipated opioid use
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- SC use
- IV use
- alcohol use, active
- opioid use, concurrent
- opioid dependence, current
- opioid withdrawal, acute
- caution: CrCl <50
- caution: pulmonary disease
- caution: depression
- caution: suicidal ideation
Drug Interactions .
Overview
naltrexone
opioid antagonist, central
- affected by altered gastrointestinal motility
- CNS depression
- central opioid antagonist
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- suicidality
- depression
- injection site reaction, severe
- injection site necrosis
- injection site abscess
- hypersensitivity reaction
- anaphylaxis
- hepatotoxicity
- cholelithiasis
- cholecystitis, acute
- pneumonia, eosinophilic
Common Reactions
- injection site reaction
- nausea
- vomiting
- headache
- asthenia
- CK elevated
- insomnia
- anorexia
- ALT or AST elevated
- diarrhea
- dizziness
- anxiety
- arthralgia
- abdominal pain
- depression
- muscle cramps
- nasopharyngitis
- back pain
- rash
- xerostomia
- HTN
- somnolence
- toothache
- platelets decr.
- opioid sensitivity incr.
Safety/Monitoring .
Monitoring Parameters
signs/symptoms of depression, suicidality
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; risk of teratogenicity not expected based on limited human data; risk of embryo-fetal death based on animal data with PO form at 5-18x recommended human dose
Lactation
Clinical Summary
may use while breastfeeding; no known risk of infant harm based on limited human data and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for naltrexone: liver; CYP450: none; Info: active metabolite
Excretion: for naltrexone: urine 53-79% (<2% unchanged), feces; Half-life: 5-10 days
Subclass: Alcohol Use Disorder ; Opioid Use Disorder
Mechanism of Action
for naltrexone: antagonizes various opioid receptors (opioid antagonist)
Formulary .
No Formulary Selected
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