National DNA Day Sale! 🧬 Save 25%️
CONTRAVE is a combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, 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 comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Limitations of Use:
• The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established.
• The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
- Most common adverse reactions (greater than or equal to 5%): nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea.
• MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly.
• Drugs Metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants, (e.g., selective serotonin reuptake inhibitors and many tricyclics), antipsychotics (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide): Consider dose reduction when using with CONTRAVE.
• Concomitant Treatment with CYP2B6 Inhibitors (e.g., ticlopidine or clopidogrel) can increase bupropion exposure. Do not exceed one tablet twice daily when taken with CYP2B6 inhibitors.
• CYP2B6 Inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) may reduce efficacy by reducing bupropion exposure, avoid concomitant use.
• Drugs that Lower Seizure Threshold: Dose CONTRAVE with caution.
• Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with CONTRAVE.
• Drug-Laboratory Test Interactions: CONTRAVE can cause falsepositive urine test results for amphetamines.
• Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue CONTRAVE if symptoms develop.
• Risk of seizure may be minimized by adhering to the recommended dosing schedule and avoiding coadministration with high-fat meal.
• Increase in Blood Pressure and Heart Rate: Monitor blood pressure and heart rate in all patients, especially those with cardiac or cerebrovascular disease.
• Hepatotoxicity: Cases of hepatitis and clinically significant liver dysfunction observed with naltrexone exposure.
• Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
• Use of Antidiabetic Medications: Weight loss may cause hypoglycemia. Monitor blood glucose.
