Litorva 10, 20, 40, 80 mg

/ Dexcel Pharma Technologies Ltd

General: Before instituting therapy with this product, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise and weight reduction in obese patients, and to treat underlying medical problems. The patient should continue on a standard cholesterol lowering diet during treatment with this product. The usual starting dose is 10 mg or 20 mg once daily. The dosage range is 10 to 80 mg once daily. Starting and maintenance doses should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response. Adjustment of dosage should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once a day.
Doses may be given at any time of day with or without food.
After initiation and/or upon titration of this product, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Therapy with lipid-altering agents should be a component of multiple-risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
Please refer to the license holder for further details.

This medicinal product is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides and to increase HDL Cholesterol in patients with primary hypercholesterolemia including familial hypercholesterolemia (heterozygous variant) or combined (mixed) hyperlipidemia (corresponding to types IIa and IIb of the fredrickson classification) when response to diet and other non-pharmacological measures is inadequate.
This product is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. LDL apheresis) or if such treatments are unavailable.
Pediatric patients (10-17 years of age):
Atorvastatin is indicated as an adjunct to diet to reduce total–C, LDL-C and apo B levels in boys and postmenarchal girls 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
1. LDL-C remains >or = 190 mg/dl or
2. LDL-C remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient.
Prevention of cardiovascular and/or cerebrovascular event such as MI or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor.
In patients with clinically evident coronary heart disease, this drug is indicated to:
Reduce the risk of non-fatal myocardial infarction.
Reduce the risk of fatal and non-fatal stroke.
Reduce the risk for revascularization procedures.
Reduce the risk of hospitalization for CHF.
Reduce the risk of angina.

Acute liver failure or decompensated cirrhosis.
Hypersensitivity to atorvastatin or to any of the excipients. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported.

Please refer to the license holder for further details.

Please refer to the license holder for further details.

Please refer to the license holder for further details.

Please refer to the license holder for further details.

Please refer to the license holder for further details.