Each film coated tablet contains: Atorvastatin (as calcium) 10 mg, 20 mg & 40 mg.
Atorvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (a statin), is a lipid regulating drug with actions on plasma lipids.
Action
Pharmacology: Pharmacokinetics: Atorvastatin is rapidly absorbed from the gastrointestinal tract. It has low absolute bioavailability of about 12% due to pre-systemic clearance in the gastrointestinal mucosa and/or first-pass metabolism in the liver, its primary site of action. Atorvastatin is metabolized by the cytochrome P450 isoenzyme CYP3A4 to a number of compounds which are also active inhibitors of HMG-CoA reductase. The mean plasma elimination half-life of atorvastatin is about 14 hours although the half-life of inhibitory activity for HMG-CoA reductase is approximately 20 to 30 hours due to the contribution of the active metabolites. It is 98% bound to plasma proteins. Atorvastatin is excreted as metabolites, primarily in the bile.
Indications/Uses
Atorvastatin is used to reduce LDL-cholesterol, apolipoprotein B, and triglycerides, and to increase HDL-cholesterol in the treatment of hyperlipidaemias, including hypercholesterolaemias and combined (mixed) hyperlipidaemias (type IIa or IIb hyperlipoproteinaemias), hypertriglyceridaemia (type IV), and dysbetalipoproteinaemia (type III). It can also be effective as adjunctive therapy in patients with homozygous familial hypercholesterolaemia who have some LDL-receptor function.
Dosage/Direction for Use
The usual initial dose is 10 mg daily which may be adjusted at intervals of 4 weeks up to a maximum of 80 mg daily or as prescribed by the physician.
Contraindications
Active liver disease or elevated serum transaminase greater than three times the upper limit of normal.
Pregnancy and Lactation.
Special Precautions
Atorvastatin should not be given to patients with acute liver disease or unexplained persistently raised serum-aminotransferase concentrations. It should also be used with caution in patients with severe renal impairment.
Adverse Reactions
The most common adverse effects are gastrointestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision, insomnia, dysgeusia, nausea and vomiting, diarrhea, abdominal pain, constipation, dyspepsia and flatulence, muscle cramps, cholestatic jaundice, pruritus, hypoglycemia, hyperglycemia, anorexia, pancreatitis, alopecia, impotence, weight gain, Steven-Johnson's syndrome, back and chest pain, peripheral edema, malaise and fatigue.
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