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Vivitrol Generic Name & Formulations
Legal Class
Rx
General Description
Naltrexone 380mg/vial; ext-rel susp for IM inj; contains polylactide-co-glycolide (PLG).
Pharmacological Class
Opioid antagonist.
How Supplied
Vial—1 (w. supplies)
Manufacturer
Generic Availability
NO
Vivitrol Indications
Indications
Alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting, in conjunction with psychosocial support (eg, counseling or group therapy). Prevention of relapse to opioid dependence following opioid detoxification.
Vivitrol Dosage and Administration
Adult
Must be administered by a healthcare provider as an IM inj into alternating buttocks. 380mg once every 4 weeks. Switching from buprenorphine, buprenorphine/naloxone, or methadone: monitor for precipitation of withdrawal symptoms and treat with non-opioid drugs.
Children
Not established.
Vivitrol Contraindications
Contraindications
Concomitant opioids. Current physiologic opioid dependence. Acute opiate withdrawal. Failed naloxone challenge test. Positive urine test for opioids. Previous hypersensitivity to PLG or carboxymethylcellulose (in diluent).
Vivitrol Boxed Warnings
Not Applicable
Vivitrol Warnings/Precautions
Warnings/Precautions
Vulnerability to opioid overdose (eg, at end of a dosing interval, after missing a dose, or after discontinuing treatment); strongly consider prescribing naloxone for emergency treatment. Precipitation of opioid withdrawal: consider naloxone challenge test before treating to exclude recent (7–10 days) opioid use. Moderate to severe renal dysfunction. Risk of hepatic injury; discontinue if acute hepatitis develops. Risk of eosinophilic pneumonia; follow-up if respiratory symptoms occur. Monitor for depression and/or suicidality. Advise patient of reduced post-treatment opioid tolerance and of danger of attempting to overcome opioid blockade; advise use of medication alert documentation. Coagulation disorders. Discontinue if hypersensitivity reactions develop. Elderly. Pregnancy. Nursing mothers.
REMS
Vivitrol Pharmacokinetics
See Literature
Vivitrol Interactions
Interactions
See Contraindications. Antagonizes opioids (eg, antitussives, antidiarrheals, analgesics); use non-opioids, and/or anesthesia if pain management is necessary. May interfere with urine opioid tests.
Vivitrol Adverse Reactions
Adverse Reactions
Nausea, vomiting, muscle cramps, somnolence/sedation, fatigue, headache, dizziness, decreased appetite, inj site reactions (may be serious; eg, induration, cellulitis, hematoma, abscess, sterile abscess, necrosis), hepatotoxicity; rare: allergic (eosinophilic) pneumonia.
Vivitrol Clinical Trials
See Literature
Vivitrol Note
Not Applicable
Vivitrol Patient Counseling
See Literature
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