Hexagon Pharma


Full Prescribing Info
Atorvastatin calcium.
Each film-coated tablet contains: Atorvastatin Calcium equivalent to Atorvastatin 20 mg.
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 in 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.
Primary hypercholesterolemia, heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia in patient who have not responded adequately to diet & other appropriate measures.
Dosage/Direction for Use
The initial dose is 10 mg daily which may be adjusted at intervals of 4 weeks up to a maximum of 80 mg daily.
Active liver disease, persistent elevation of serum transaminase, pregnancy, lactation, women of child bearing potential.
Use In Pregnancy & Lactation
Contraindicated during pregnancy & lactation.
Adverse Reactions
Effects on the blood: An immune thrombocytopenia attributed to atorvastatin has been reported in patient. Adverse hematological reactions had not been noted when the patient previously received simvastatin.
Effects on the liver: Acute hepatitis was diagnosed in a woman 12 weeks after starting treatment with atorvastatin. She had previously been taking Simvastatin and Fenofibrate without adverse effect, but with persistent hypercholesterolemia. Following cessation of atorvastatin, liver function test returned to normal and the patient recommended simvastatin therapy again without adverse effect.
Effects on skeletal muscle: Muscle disorders are well recognised adverse effect of lipid regulating drugs such as fibrates and statins.
A woman developed rhabdomyolysis two months after starting atorvastatin. The patient was already taking ciclosporin following renal transplantation and had a history of systemic lupus erythematus.
Effect on the skin: Toxic epidermal necrolysis apparently caused by atorvastatin.
Drug Interactions
Antacids; Antipyirne; Colestipol; Digoxin; Oral Contraceptives.
Store at temperatures not exceeding 30°C.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
FC tab 20 mg x 100's.
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