Concise Prescribing Info
Atorvastatin Ca
Adjunct to diet for reduction of elevated total-cholesterol, LDL-cholesterol, apolipoprotein B, & triglycerides in patients w/ primary hypercholesterolaemia (heterozygous familial & non familial) & mixed dyslipidemia. Adjunct to diet for the treatment of patients w/ elevated serum triglyceride levels. Adjunct to lipid lowering treatment in patients w/ homozygous familial hypercholesterolaemia.
Dosage/Direction for Use
Adult Individualized dosage. Initially 10 mg daily. Dose range: 10-80 mg once daily. Homozygous familial hypercholesterolaemia 10-80 mg daily as adjunct to other lipid-lowering treatments.
May be taken with or without food.
Hypersensitivity. Active liver disease or unexplained persistent serum transaminase elevations exceeding 3 times the upper limit of normal. Pregnancy & lactation.
Special Precautions
Perform liver function tests prior to & at 12 wk following initiation of therapy & dose elevation. Reduce dose or discontinue therapy if increase in ALT levels >3 times the upper limit of normal persists. Alcoholics or patients w/ history of liver disease. Skeletal muscle effects; rhabdomyolysis w/ acute renal failure secondary to myoglobinuria has been reported w/ other drugs of this class. Discontinue therapy in cases of marked elevated CPK levels or diagnosed or suspected myopathy, or w/ a risk factor predisposing to development of renal failure secondary to rhabdomyolysis (eg, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders & uncontrolled seizures). Hepatic insufficiency.
Adverse Reactions
Constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, asthenia, diarrhoea, insomnia, elevated serum ALT & CPK levels.
Drug Interactions
Increased risk of myopathy w/ cyclosporin, fibric acid derivatives, erythromycin, azole antifungals or niacin. Increased steady state plasma digoxin conc w/ multiple doses of atorvastatin. Higher plasma conc of atorvastatin w/ erythromycin. Increased plasma conc of norethisterone & ethinyl oestradiol. Decreased prothrombin time w/ warfarin. Lower plasma conc w/ colestipol.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Tonact FC tab 10 mg
10 × 10's
Tonact FC tab 20 mg
10 × 10's
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