Contrave Extended-Release

NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE

Manufacturer: Nalpropion Pharmaceuticals LLC

Score: 144.0

Quick Summary

Contrave Extended-Release is a combination of naltrexone and bupropion used for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. The drug works by affecting two areas of the brain involved in food intake regulation. It is essential to follow the recommended dosing schedule, and patients should be monitored for potential adverse reactions, including suicidal thoughts and behaviors, neuropsychiatric adverse events, seizures, and allergic reactions. The drug is contraindicated in patients with uncontrolled hypertension, seizure disorder, or a history of seizures, and those using other bupropion-containing products or monoamine oxidase inhibitors (MAOIs).

Key Clinical Findings and Indications

Chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition
Combination of naltrexone and bupropion

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors, neuropsychiatric adverse events, seizures, and allergic reactions

Contraindications

Uncontrolled hypertension
Seizure disorder or a history of seizures
Use of other bupropion-containing products
Monoamine oxidase inhibitors (MAOIs)
Known allergy to bupropion, naltrexone, or any other component of Contrave

Adverse Reactions

Nausea
Constipation
Headache
Vomiting
Dizziness
Insomnia
Dry mouth
Diarrhea

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal or hepatic impairment

Chronic weight management

Adult Dose

Week 1: 1 tablet in the morning, Week 2: 1 tablet in the morning and 1 tablet in the evening, Week 3: 2 tablets in the morning and 1 tablet in the evening, Week 4 and onward: 2 tablets in the morning and 2 tablets in the evening

Pediatric Dose

Special Population Considerations

Pregnancy

Weight loss offers no benefit to a pregnant patient and may cause fetal harm
Available pharmacovigilance data and data from clinical trials with the individual components of Contrave use in pregnant patients have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Nursing Mothers

It is not known whether Contrave is excreted in human milk

Pediatric Use

The safety and effectiveness of Contrave in pediatric patients below the age of 18 have not been established

Geriatric Use

Of the 3,239 subjects who participated in clinical trials with Contrave, 62 (2%) were 65 years and older and none were 75 years and older
Older individuals may be more sensitive to the central nervous system adverse effects of Contrave

Similar Drugs

Bupropion Hydrochloride (XL)

BUPROPION HYDROCHLORIDE

Bryant Ranch Prepack

Similarity: 71.1%