Finished product reference

Amiloride / Hyrochlorothiazide

Tablet · Oral · 5 mg/50 mg

List code
55
Pharmacologic class
Diuretic combination (potassium-sparing diuretic + thiazide)

What it is and how it works

Hydrochlorothiazide inhibits the Na+/Cl− co-transporter in the distal convoluted tubule, causing natriuresis and diuresis. Amiloride blocks epithelial sodium channels in the collecting duct, adding a modest diuretic effect and reducing thiazide-induced potassium loss.

Indications

Hypertension; oedema, including that due to heart failure or hepatic cirrhosis, where potassium conservation is desirable.

Dosage and administration (summary)

Oral; for amiloride 5 mg/hydrochlorothiazide 50 mg tablets, usually half to one tablet daily for hypertension, up to two tablets daily for oedema.

Contraindications

Hyperkalaemia; concomitant potassium supplements or other potassium-sparing diuretics; severe renal impairment or anuria; Addison's disease; hypercalcaemia.

Warnings and precautions

Risk of hyperkalaemia, especially in renal impairment, diabetes, the elderly and with ACE inhibitors, angiotensin II receptor antagonists or NSAIDs; monitor serum electrolytes and renal function. Thiazides may cause hyponatraemia, hyperuricaemia, hyperglycaemia and photosensitivity.

Pregnancy

Not recommended in pregnancy; thiazides may reduce plasma volume and cause neonatal thrombocytopenia.

Storage and supply

Store below 25 °C, protected from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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