Vivitrol Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.

1.1 Alcohol Dependence

VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration.

1.2 Opioid Dependence

VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification.


There is currently no drug history available for this drug.

Other Information

VIVITROL® (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, to be administered by intramuscular injection. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity.

Naltrexone is designated chemically as morphinan-6-one, 17 (cyclopropylmethyl) 4,5-epoxy-3,14-dihydroxy-(5α) (CAS Registry # 16590-41-3). The molecular formula is C20H23NO4 and its molecular weight is 341.41 in the anhydrous form (ie, < 1% maximum water content). The structural formula is:

Structural Formula

Naltrexone base anhydrous is an off-white to a light tan powder with a melting point of 168-170ºC (334-338ºF). It is insoluble in water and is soluble in ethanol.

VIVITROL is provided as a carton containing a vial each of VIVITROL microspheres and diluent, one 5-mL syringe, one 1-inch 20-gauge preparation needle, two 1.5-inch 20-gauge and two 2-inch 20-gauge administration needles with needle protection device.

VIVITROL microspheres consist of a sterile, off-white to light tan powder that is available in a dosage strength of 380 mg of naltrexone per vial. Naltrexone is incorporated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 337 mg of naltrexone per gram of microspheres.

The diluent is a clear, colorless solution. The composition of the diluent includes carboxymethylcellulose sodium salt, polysorbate 20, sodium chloride, and water for injection. The microspheres must be suspended in the diluent prior to injection.

Vivitrol Manufacturers

  • Alkermes, Inc.
    Vivitrol (Naltrexone) Kit [Alkermes, Inc.]
  • Alkermes, Inc.
    Vivitrol (Naltrexone) Kit [Alkermes, Inc.]

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