diamox-Acetazolamide
FDA Labeled Indication
1) Overview
FDA Approval: Adult, yes; Pediatric, yes (extended-release capsules only, 12 yr and older)
Efficacy: Adult, Effective; Pediatric, Effective
Recommendation: Adult, Class IIa; Pediatric, Class IIa
Strength of Evidence: Adult, Category B; Pediatric, Category B
See Drug Consult reference: RECOMMENDATION AND EVIDENCE RATINGS
2) Summary:
Indicated for the prevention or amelioration of symptoms associated with acute mountain sickness
Normalized sleep-disordered breathing associated with high-altitude
3) Adult:
a) Acetazolamide prophylaxis resulted in a substantial decrease in incidence and severity of acute mountain sickness in comparison to placebo treatment. In a large, randomized, double-blind, controlled trial comparing the efficacy of ginkgo biloba and acetazolamide, 118 healthy non-Nepali trekkers on the approach to Mount Everest received acetazolamide 250 milligrams twice daily, and 119 similar trekkers received placebo. Treatment was initiated at approximately 4300 meters (m)/14,100 feet (ft) elevation. None of the participants had mountain sickness at the initiation of treatment, according to the Lake Louise questionnaire, a validated standard for evaluation of acute mountain sickness in the field. Re-evaluation at 4928 m/16,168 ft revealed acute mountain sickness in 12% of the acetazolamide group and in 34% of the placebo group (odds ratio 3.76; 95% confidence interval (CI), 1.91 to 7.39). Mountain sickness was severe in 3% of the acetazolamide group and 18% of the placebo group (odds ratio, 6.46; 95% CI, 2.15 to 19.4). In the acetazolamide group, the number needed to treat was 4 to prevent one episode of acute mountain sickness and 7 to prevent one case of severe mountain sickness. Addition of ginkgo biloba 120 mg to the acetazolamide treatment did not improve outcome in comparison to acetazolamide and, in fact, appeared to somewhat reduce the efficacy of acetazolamide (Gertsch et al, 2004).