What is the dose of naltrexone hydrochloride in Contrave (bupropion and naltrexone)?

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Contrave Naltrexone Dosage

Contrave contains 8 mg of naltrexone hydrochloride per tablet, combined with 90 mg of bupropion hydrochloride in an extended-release formulation. 1, 2

Dosing Schedule and Titration

The maintenance dose of Contrave for obesity management is 32 mg naltrexone/360 mg bupropion daily, which translates to 4 tablets per day (2 tablets twice daily) 1, 3

Week-by-Week Titration Protocol

  • Week 1: 8 mg naltrexone/90 mg bupropion once daily in the morning (1 tablet AM) 3
  • Week 2: 8 mg naltrexone/90 mg bupropion twice daily (1 tablet AM, 1 tablet PM) 3
  • Week 3: 16 mg naltrexone/180 mg bupropion in the morning and 8 mg naltrexone/90 mg bupropion in the evening (2 tablets AM, 1 tablet PM) 3
  • Week 4 and beyond: 16 mg naltrexone/180 mg bupropion twice daily (2 tablets AM, 2 tablets PM) - this is the maintenance dose 3

Clinical Efficacy Data

The fixed-dose combination demonstrated statistically significant weight loss across four Phase III trials (COR-I, COR-II, COR-BMOD, COR-DM) involving 4,536 participants, with average weight loss of approximately 11-22 lbs (5-9 kg) over 52-56 weeks 4

In the COR-I trial specifically, 48% of participants on the 32 mg naltrexone/360 mg bupropion dose achieved ≥5% weight loss compared to 16% on placebo 5

Critical Safety Considerations

Absolute Contraindications

  • Chronic opioid therapy or opioid dependence - naltrexone will precipitate severe withdrawal 3, 2
  • Uncontrolled hypertension - both components can elevate blood pressure 1, 3
  • Seizure disorders or conditions predisposing to seizures - bupropion lowers seizure threshold 1, 3
  • Pregnancy - contraindicated in women who are or may become pregnant 3
  • Eating disorders (bulimia or anorexia nervosa) - increased seizure risk 3
  • Abrupt discontinuation of alcohol, benzodiazepines, or antiepileptic drugs - dramatically increases seizure risk 3
  • Current or recent MAOI use (within 14 days) 1

Dose Adjustments for Organ Impairment

  • Moderate to severe hepatic impairment: Maximum dose is 8 mg naltrexone/90 mg bupropion once daily (1 tablet daily) 1, 3
  • Moderate to severe renal impairment: Reduce total daily dose by 50% 1, 3

Monitoring Requirements

  • Blood pressure and heart rate: Monitor periodically, especially during the first 12 weeks, as transient increases of approximately 1.5 mm Hg may occur initially 1, 3, 5
  • Efficacy assessment: If <5% weight loss at 12 weeks, discontinue and consider alternative treatment 1
  • Neuropsychiatric symptoms: Monitor for suicidal ideation, particularly in patients under 24 years old 3

Common Pitfalls to Avoid

Do not prescribe Contrave without confirming the patient is not taking any opioid medications, including partial agonists like buprenorphine - this is an absolute contraindication 3

Do not administer the second dose late in the day - give before 3 PM to minimize insomnia risk from the bupropion component 3

Do not exceed the maximum dose of 32 mg naltrexone/360 mg bupropion daily to maintain seizure risk at approximately 0.1% 3, 5

The most common adverse events are nausea (29.8%), headache, constipation, dizziness, vomiting, and dry mouth, with nausea being significantly more frequent than placebo (5.3%) 5

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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