Lipicon 10 mg tablet: Each film-coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 10 mg.
Lipicon® is a preparation of Atorvastatin, a synthetic lipid lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methyglutaryl-coenzyme A (HMG-CoA) reductase, This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug lowers elevated total cholesterol (C), low density lipoprotein (LDL) cholesterol, apolipoprotein B(apo B), and triglycerides (TG) in patients with primary hypercholesterolemia and with mixed dyslipidemia.
Atorvastatin can be administrated within the dosage range of 10 - 80 mg/day as a single daily dose. Atorvastatin can be taken at any time of the day, with or without food. Therapy should be individualised according to the target lipid levels, the recommended goal of therapy, and the patient's response. After initial and/or upon titration of Atorvastatin, lipid level should be re-analysed within 4 weeks and dosage adjusted according to the patient's response. Renal disease has no influence on the plasma concentrations or on the LDL-C reduction of Atorvastatin.
thus, no adjustment of the dose is required. Plasma concentrations of Atorvastatin are markedly increased in patients with chronic alcoholic liver disease (Childs-Pugh B). The benefits of therapy should be weighed against the risks when Atorvastatin is to be given to patients with hepatic insufficiency.
Based on experience with other HMG-CoA reductase inhibitors, caution should be exercised when atorvastatin is administered with inhibitors of cytochrome P450 3A4 (e.g. cyclosporin, macrolide antibiotics including erythromycin and azole antifungals or niacin). Co-administration of an oral antacid suspension, containing magnesium and aluminium hydroxide, with.
Atorvastatin decreased Atorvastatin plasma concentrations approximately 35%, however, LDL-C reduction was not altered. Plasma concentrations of Atorvastatin were lower (approximately 25%) when cholestyramine was co-administered than when either drug was given alone. Co-administration of multiple doses of Atorvastatin and digoxin increased steady-state plasma digoxin concentrations by approximately 20%. Patients taking digoxin should be monitored appropriately.
Cholesterol and other products of cholesterol biosynthesis are essential for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause foetal harm when administered to pregnant women. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers. Atorvastatin should be administered to women of child-bearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient appraised of the potential hazard to the fetus.
Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. If an increase in ALT or AST of > 3 times the upper limit of normal persist, reduction of dose or withdrawal of Atorvastatin is recommended. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis, e.g. severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures.
Do not store above 30°C. Keep away from light and wet place. Keep out of reach of children.