DIDRALIN Tablet Ref.[107882] Active ingredients: Hydrochlorothiazide

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Low ceiling diuretics, thiazides
ATC code: C03AA03

Hydrochlorothiazide is a diuretic with antihypertensive properties. It acts by inhibiting the renal tubular re-absorption of sodium and chloride ions, which are excreted with an accompanying volume of water. Potassium excretion is also promoted.

Non-melanoma skin cancer

Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed. One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively. High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC. A clear cumulative dose response relationship was observed for both BCC and SCC. Another study showed a possible association between lip cancer (SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy. A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).

5.2. Pharmacokinetic properties

About 70% of an oral dose of hydrochlorothiazide is absorbed. It has a plasma half-life of 5.6 to 14.8 hours. It is excreted unchanged in the urine. It crosses the placental barrier and is secreted in breast milk.

5.3. Preclinical safety data

No relevant data.

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