Finished product reference
Asa / Atorvastatin / Hydrochlorothiazide / Valsartan
Tablet · Oral · 81 mg/20 mg/12.5 mg/40 mg
- List code
- 50635
- Salt form
- Calcium
- Pharmacologic class
- Cardiovascular polypill (antiplatelet / statin / angiotensin II receptor antagonist / 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; valsartan blocks the angiotensin II AT1 receptor; hydrochlorothiazide is a thiazide diuretic. Together they target the main modifiable cardiovascular risk factors.
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; anuria or severe renal impairment; concomitant aliskiren in diabetes or 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 interacting drugs), hypotension and hyperkalaemia. A fixed combination may not allow individual dose adjustment.
Pregnancy
Contraindicated in pregnancy (angiotensin II receptor antagonist 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.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.