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ATC codes: C03AA03
Indication
Essential hypertension ICD11 code: BA00.Z
INN
Hydrochlorothiazide
Medicine type
Chemical agent
List type
Core
Formulations
Oral > Liquid: 50 mg per 5 mL
Oral > Solid: 25 mg ; 12.5 mg
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 1987 (TRS 770)
Changed in 1991 (TRS 825)
Changed in 1997 (TRS 882)
Changed in 2009 (TRS 958)
Sex
All
Age
Adolescents and adults
Therapeutic equivalence
Medicines within the same pharmacological class can be used
Therapeutic equivalence limitations
Any other thiazide-type diuretic currently in broad clinical use
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The application for hydrochlorothiazide (new formulations) was commissioned by the Secretariat as part of a review of the section on medicines used in heart failure. It was prepared by the NHS Centre for the Evaluation of Effectiveness of Health Care (CeVEAS), Local Health Unit, Modena, Italy. Comments on the application were received from MSF. An expert review of the application was prepared by Mr Andy Gray. The Committee noted the one Cochrane Review (1) (n = 202) cited showed that thiazides are useful in the relief of symptoms, reduce episodes of de-compensation, and improve exercise tolerance, but do not affect the outcome of heart failure. It also noted evidence of relative efficacy of thiazides in hypertension when compared to beta-blockers (2). The Committee noted that although thiazides have various potentially serious side-effects, they are relatively safe at doses below 25 mg/day and that their antihypertensive effect has largely been achieved at this dose (3). The Committee noted that the application did not present any evidence for the safety or efficacy of thiazides in children and therefore was not able to recommend its addition to the EMLc but requested a further review of paediatric evidence for use of thiazides for hypertension. The Committee supported the inclusion of the 12.5 mg tablet and the suspension form 50 mg per 5 mL of hydrochlorothiazide to the Model List for the treatment of hypertension. 1. Faris R et al. Diuretics for heart failure. Cochrane Database of Systematic Reviews, 2006, CD003838. 2. Wiysonge CS et al. Beta-blockers for hypertension. Cochrane Database of Systematic Reviews, 2007, (1):CD002003. 3. Sica DA. Diuretic-related side effects: development and treatment. Journal of Clinical Hypertension, 2004, 6:532–540.