Naltrexone is an opioid antagonist sold in the U.S. under 2 brand and generic names, for alcoholism, opioid-related disorders and drug overdose. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Vivitrol (application NDA021897). Other naltrexone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
VIVITROL must be prepared and administered by a healthcare provider ( 2.1 , 2.6 ). Prior to initiating VIVITROL, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization ( 2.1 ). The recommended dose of VIVITROL is 380 mg delivered intramuscularly (deep) as a gluteal injection, every 4 weeks or once a month, alternating buttocks for each subsequent injection, using the carton components provided ( 2.1 ). VIVITROL must ONLY be administered as a deep intramuscular gluteal injection ( 2.1 ). See Full Prescribing Information for complete Directions for Use ( 2.6 ). 2.1 Important Dosage and Administration Information VIVITROL must be prepared and administered by a healthcare provider. VIVITROL must ONLY be administered as a deep intramuscular gluteal injection. Parenteral products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. A properly mixed suspension will be milky white, will not contain clumps, and will move freely down the wall of the vial [see Dosage and Administration ( 2.6 )] . Prior to initiating VIVITROL, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be…
The following clinically significant adverse reactions are described elsewhere in the labeling: Accidental Opioid Overdose [ see Warnings and Precautions ( 5.1 )] Injection Site Reactions [see Warnings and Precautions ( 5.2 )] Precipitated Opioid Withdrawal [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Depression and Suicidality [see Warnings and Precautions ( 5.5 )] Eosinophilic Pneumonia [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (i.e, those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders ( 6 ). The adverse events seen most frequently in association with VIVITROL therapy in opioid-dependent patients (i.e., those occurring in ≥2% of patients treated with VIVITROL and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Alkermes, Inc. at 1-800-VIVITROL (1-800-848-4876)…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Kit | Generic | $37 | View → | |
| 2 | 46/100 | Prescription | Kit | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| REL;PLAIN | 150 mg | white | round | — |
| NB;890 | 8 mg / 90 mg | blue | round | — |
| NB;890 | 8 mg / 90 mg | blue | round | — |
| CE;38 | 50 mg | yellow | oval | — |
| 326 | 50 mg | yellow | round | — |
| 326 | 50 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
VIVITROL is contraindicated in: Patients receiving opioid analgesics [see Warnings and Precautions ( 5.3 )] . Patients with current physiologic opioid dependence [see Warnings and Precautions ( 5.3 )] . Patients in acute opioid withdrawal [see Warnings and Precautions ( 5.3 )] . Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids [see Warnings and Precautions ( 5.3 )] . Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent [see Warnings and Precautions ( 5.8 )]. VIVITROL is contraindicated in: Patients receiving opioid analgesics ( 4 ). Patients with current physiologic opioid dependence ( 4 ). Patients in acute opioid withdrawal ( 4 ). Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids ( 4 ). Patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent ( 4 ).
Patients taking VIVITROL may not benefit from opioid-containing medicines. Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations and opioid analgesics. Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations, and opioid analgesics ( 7 ).
| $37 |
| View → |
| yellow |
| round |
| — |
| EL;15 | 50 mg | yellow | round | — |
|---|