CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity 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 (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
DOSAGE AND ADMINISTRATION
CONTRAVE dosing should be escalated according to the following schedule:
|Morning Dose||Evening Dose|
|Week 1||1 tablet||None|
|Week 2||1 tablet||1 tablet|
|Week 3||2 tablets||1 tablet|
|Week 4 - Onward||2 tablets||2 tablets|
A total daily dosage of two CONTRAVE 8 mg/90 mg tablets twice daily (32 mg/360 mg) is reached at the start of Week 4.
CONTRAVE should be taken by mouth in the morning and in the evening. The tablets should not be cut, chewed, or crushed. Total daily doses greater than 32 mg/360 mg per day (two tablets twice daily) are not recommended. In clinical trials, CONTRAVE was administered with meals. However, CONTRAVE should not be taken with a high-fat meal because of a resulting significant increase in bupropion and naltrexone systemic exposure.
Patients may develop elevated blood pressure or heart rate during CONTRAVE treatment; the risk may be greater during the initial three months of therapy. Because patients with hypertension may be at increased risk for developing blood pressure elevations, such patients should be monitored for this potential effect when initiating treatment with CONTRAVE.
Response to therapy should be evaluated after 12 weeks at the maintenance dosage. If a patient has not lost at least 5% of baseline body weight, discontinue CONTRAVE, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
The following adverse reactions are discussed in other sections of the labeling:
- Suicidal Behavior and Ideation
- Neuropsychiatric Adverse Events
- Increase in Blood Pressure and Heart Rate
- Allergic Reactions
- Angle-Closure Glaucoma