Finished product reference
Atorvastatin / Ezetimibe
Tablet · Oral · 40 mg/10 mg
- List code
- 52745
- Salt form
- Calcium
- Pharmacologic class
- Lipid-regulating combination (HMG-CoA reductase inhibitor + cholesterol absorption inhibitor)
What it is and how it works
Atorvastatin inhibits hepatic HMG-CoA reductase, reducing cholesterol synthesis and up-regulating LDL receptors. Ezetimibe inhibits the intestinal sterol transporter NPC1L1, reducing absorption of dietary and biliary cholesterol; the combination gives complementary LDL-cholesterol lowering.
Indications
Primary hypercholesterolaemia or mixed hyperlipidaemia not adequately controlled by a statin alone, or in patients already treated with both drugs separately; homozygous familial hypercholesterolaemia; reduction of cardiovascular risk in coronary heart disease.
Dosage and administration (summary)
One tablet orally once daily (ezetimibe 10 mg with atorvastatin 10–80 mg), at any time of day with or without food.
Contraindications
Active liver disease or unexplained persistent elevation of serum transaminases; pregnancy and breastfeeding; concomitant glecaprevir/pibrentasvir; hypersensitivity.
Warnings and precautions
Myopathy and rhabdomyolysis may occur, especially at high doses or with interacting drugs (e.g. ciclosporin, clarithromycin, HIV protease inhibitors, fibrates); patients should report unexplained muscle pain. Check liver function before and during treatment. Caution with fusidic acid, in hypothyroidism, renal impairment and heavy alcohol use.
Pregnancy
Contraindicated in pregnancy.
Storage and supply
Store below 30 °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.
Other presentations of the same active ingredient
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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