Ignore.pdf

200063s000lbl.pdf
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🔗 Source: accessdata.fda.gov
📊 Size: 1.29 MB
👤 Author: FDA/CDER
⬇️ Downloads: 81

Summary

CONTRAVE (naltrexone HCl and bupropion HCl) is indicated for chronic weight management in adults with a BMI of 30 kg/m2 or greater, or 27 kg/m2 or greater with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity. The medication has a boxed warning for suicidal thoughts and behaviors, and neuropsychiatric reactions. CONTRAVE is contraindicated in patients with uncontrolled hypertension, seizure disorders, anorexia nervosa or bulimia, chronic opioid use, and during or within 14 days of taking monoamine oxidase inhibitors. Common adverse reactions include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

Description

CONTRAVE (naltrexone HCl and bupropion HCl) is indicated for chronic weight management in adults with a BMI of 30 kg/m2 or greater, or 27 kg/m2 or greater with...

Technical Information

  • File Format: PDF
  • File Size: 1.29 MB
  • Pages: 47
  • Language: EN
  • Author: FDA/CDER
  • Total Downloads: 81
  • Last Updated: 7 days ago

Document Overview

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