Bupropiondrug info
12 HR bupropion hydrochloride 90 MG / naltrexone hydrochloride 8 MG Extended Release Oral Tablet [Contrave]
What it is used for
CONTRAVE is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. CONTRAVE is a combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition.
Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. Coadministration with other naltrexone-containing products is not recommended. Coadministration with other bupropion-containing products is contraindicated.
Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. CONTRAVE contains naltrexone and bupropion. Coadministration with other naltrexone-containing products is not recommended. Coadministration with other bupropion-containing products is contraindicated.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 10, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
CONTRAVE extended-release tablets contain naltrexone hydrochloride (HCl) and bupropion HCl. Naltrexone HCl, USP, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone HCl is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. Naltrexone HCl has the chemical name of morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5α)-. The empirical formula is C 20 H 23 NO 4 ∙HCl and the molecular weight is 377.86.
The structural formula is: Naltrexone HCl is a white to yellowish, crystalline compound. It is soluble in water to the extent of about 100 mg/mL. Bupropion HCl is an antidepressant of the aminoketone class. Bupropion HCl closely resembles the structure of diethylpropion. It is designated as (±)-1-(3 chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propranone hydrochloride. It is related to phenylethylamines. The empirical formula is C 13 H 18 ClNO∙HCl and the molecular weight is 276.2.
The structural formula is: Bupropion HCl powder is white, crystalline, and highly soluble in water. CONTRAVE is available for oral administration as a round, bi-convex, film-coated, extended-release tablet. Each tablet has a trilayer core composed of two drug layers, containing the drug and excipients, separated by a more rapidly dissolving inert layer. Each tablet contains 8 mg of naltrexone HCl and 90 mg of bupropion HCl. Tablets are blue and are debossed with NB-890 on one side. Each tablet contains the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, L-cysteine hydrochloride, crospovidone, magnesium stearate, hypromellose, edetate disodium, lactose monohydrate, colloidal silicon dioxide, Opadry II Blue and FD&C Blue #2 aluminum lake. Chemical Structure Chemical Structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 10, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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