What are the recommended starting and titration doses of phentermine/topiramate extended‑release (Qsymia) for weight loss in an adult with a body mass index ≥30 kg/m² (or ≥27 kg/m² with a weight‑related comorbidity)?

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Phentermine/Topiramate Dosing for Weight Loss

Starting Dose and Initial Titration

Begin with phentermine/topiramate ER 3.75 mg/23 mg once daily for 14 days, then increase to 7.5 mg/46 mg once daily as the standard maintenance dose. 1, 2

  • This two-week initiation period allows for gradual tolerance development before reaching the therapeutic maintenance dose 1
  • The 7.5 mg/46 mg dose produces an average weight loss of 7.8% of baseline body weight compared to 1.2% with placebo 1, 2

Dose Escalation Protocol

If weight loss is less than 3% after 12 weeks on the 7.5 mg/46 mg dose, escalate to 11.25 mg/69 mg daily for 14 days, followed by the maximum dose of 15 mg/92 mg daily. 1

  • The maximum 15 mg/92 mg dose achieves approximately 9.8% weight loss compared to 1.2% with placebo 1, 2
  • At the maximum dose, 70% of patients achieve ≥5% weight loss and 48% achieve ≥10% weight loss 3
  • Discontinue the medication if less than 5% weight loss is achieved after 12 weeks at the maximum dose 1, 2

Patient Eligibility Criteria

This medication is indicated for adults with: 1, 2

  • BMI ≥30 kg/m², OR
  • BMI ≥27 kg/m² with weight-related comorbidities (hypertension, type 2 diabetes, dyslipidemia)

Mandatory Pre-Treatment Screening

Absolute Contraindications to Identify

  • Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg) 1
  • Active coronary artery disease or recent cardiovascular events 1
  • Glaucoma, particularly closed-angle type 1
  • Pregnancy or inadequate contraception in women of childbearing potential 1, 2

Required Baseline Assessments

  • Obtain a negative pregnancy test in all women of childbearing potential before initiating therapy 1, 2
  • Measure baseline blood pressure and heart rate 1, 2
  • Check serum bicarbonate level to identify pre-existing metabolic acidosis 1
  • Counsel about teratogenic risk (orofacial clefts with first-trimester exposure) and need for reliable contraception 1, 2

Monitoring Schedule and Parameters

Visit Frequency

  • Monthly visits for the first 3 months 1, 2
  • Every 3 months thereafter 1, 2

Parameters to Monitor at Each Visit

  • Blood pressure and heart rate (phentermine may cause modest tachycardia) 1, 2
  • Serum bicarbonate periodically to detect metabolic acidosis 1
  • Weight and efficacy assessment 1
  • Repeat pregnancy tests as clinically indicated 1

Common Adverse Effects to Anticipate

The most frequent side effects include: 1, 2

  • Paresthesias (≈23%)
  • Dry mouth (≈19%)
  • Headache (≈16%)
  • Insomnia (≈10%)
  • Constipation and dizziness

Critical Discontinuation Protocol

If discontinuation is necessary, taper gradually by taking one capsule every other day for at least one week before stopping completely—never stop abruptly to avoid precipitating seizures. 1

Additional Therapeutic Benefits Beyond Weight Loss

Treatment produces improvements in: 1

  • Waist circumference reduction
  • Systolic and diastolic blood pressure decrease
  • Hemoglobin A1c improvement in patients with diabetes

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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