Finished product reference
Asa / Atorvastatin / Enalapril Maleate / Hydrochlorothiazide
Tablet · Oral · 81 mg/20 mg/5 mg/12.5 mg
- List code
- 50628
- Salt form
- Calcium
- Pharmacologic class
- Cardiovascular polypill (antiplatelet / statin / ACE inhibitor / thiazide diuretic)
What it is and how it works
Low-dose aspirin inhibits platelet COX-1 and thromboxane A2 formation; atorvastatin inhibits HMG-CoA reductase, lowering LDL cholesterol; enalapril inhibits angiotensin-converting enzyme, reducing angiotensin II and blood pressure; hydrochlorothiazide is a thiazide diuretic that lowers blood pressure.
Indications
Primary and secondary prevention of cardiovascular events in adults at elevated cardiovascular risk, as a fixed-dose combination to simplify treatment and improve adherence.
Dosage and administration (summary)
One tablet orally once daily.
Contraindications
Active bleeding or peptic ulcer; active liver disease or unexplained persistent transaminase elevation; history of angioedema with ACE inhibitors; anuria or severe renal impairment; hypersensitivity to aspirin, NSAIDs or sulfonamides; pregnancy and breastfeeding.
Warnings and precautions
Monitor blood pressure, renal function and serum potassium and sodium. Risk of gastrointestinal bleeding, myopathy and rhabdomyolysis (especially with CYP3A4 inhibitors), angioedema and hypotension. A fixed combination may not allow individual dose adjustment.
Pregnancy
Contraindicated in pregnancy (ACE inhibitor and statin components).
Storage and supply
Store below 25 °C, protected from moisture.
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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