Atorvastatin Calcium 10mg, 20mg, 40mg, 80mg Tablets Taj Pharma-SmPC

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Atorvastatin Calcium Tablets USP 10mg/20mg/40mg/80mg 1. Name of the medicinal product Atorvastatin Calcium 10mg Tablets USP Taj Pharma Atorvastatin Calcium 20mg Tablets USP Taj Pharma Atorvastatin Calcium 40mg Tablets USP Taj Pharma Atorvastatin Calcium 80mg Tablets USP Taj Pharma

2. Qualitative and quantitative composition a) Each film-coated tablet contains: Atorvastatin calcium trihydrate USP Equivalent to Atorvastatin 10mg Excipients q.s. b) Each film-coated tablet contains: Atorvastatin calcium trihydrate USP Equivalent to Atorvastatin 20mg Excipients q.s. c) Each film-coated tablet contains: Atorvastatin calcium trihydrate USP Equivalent to Atorvastatin 40mg Excipients q.s.

Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (totalC),LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors. 4.2 Posology and method of administration Posology The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin. The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response.

d) Each film-coated tablet contains: Atorvastatin calcium trihydrate USP Equivalent to Atorvastatin 80mg Excipients q.s.

The usual starting dose is 10 mg once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once a day.

For the full list of excipients, see section 6.1.

Co-administration with other medicines

3. Pharmaceutical form White to off white, film-coated oval tablets.

In patients taking hepatitis C antiviral agents elbasvir/grazoprevir concomitantly with atorvastatin, the dose of atorvastatin should not exceed 20 mg/day (see sections 4.4 and 4.5).

4. Clinical particulars

Primary Hypercholesterolaemia and Combined (Mixed) Hyperlipidaemia

4.1 Therapeutic indications Hypercholesterolaemia:

The majority of patients are controlled with 10 mg atorvastatin once a day. A therapeutic response is evident within 2 weeks, and the

Film-coated tablet.


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