Locol® 10 Tablet: Each film coated tablet contains Atorvastatin Calcium USP equivalent to 10 mg Atorvastatin.
Locol® 20 Tablet: Each film coated tablet contains Atorvastatin Calcium USP equivalent to 20 mg Atorvastatin.
Atorvastatin is a synthetic lipid lowering agent. It is a selective, competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
Prevention of cardiovascular disease:
In adult patients without clinically evident coronary heart diseases, but with multiple risk factors for coronary heart diseases such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, Atorvastatin is indicated to:
Hypercholesterolemia:
Atorvastatin is indicated:
The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue on the diet during treatment with Atorvastatin.
Hypercholesterolemia (Heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
The recommended starting dose of Atorvastatin is 10 or 20 mg once daily. The dosage range is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day, with or without food. Therapy should be individualized according to goal of therapy and response.
Heterozygous familial hypercholesterolemia in pediatric patients (10-17 years of age).
The recommended starting dose of Atorvastatin is 10 mg/day; the maximum recommended dose is 20 mg/day. Adjustments should be made at intervals of 4 weeks or more.
Homozygous Familial Hypercholesterolemia (FH):
The dosage of Atorvastatin in patients with Homozygous FH is 10 to 80 mg daily. Atorvastatin can be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable.
Concomitant therapy:
Atorvastatin may be used in combination with a bile acid binding resin for additive effect. The combination of HMG-CoA reductase inhibitors and fibrates should generally be avoided.
Dosage in patients with renal Insufficiency:
Renal disease does not affect the plasma concentrations nor LDL-C reduction of Atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary.
*Prescription only*
The risk of myopathy during treatment with drugs of this class is increased with concurrent administration of Cyclosporine, Fibric Acid derivatives, Niacin (Nicotinic Acid), Erythromycin, and Azole antifungals.
Drugs that affect Atorvastatin:
The following drugs have been shown to have an effect on the pharmacokinetics or pharmacodynamics of Atorvastatin: Antipyrine, Colestipol, Erythromycin, Clarithromycin, protease inhibitors & antacid.
Drugs that are affected by Atorvastatin:
The following drugs have been shown to have their pharmacokinetics or pharmacodynamics affected by Atorvastatin. These are Digoxin and oral contraceptives.
Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Overdosage:
There is no specific treatment for Atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance Atorvastatin clearance.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.