Concise Prescribing Info
Atorvastatin Ca
Adjunct to diet for patients w/ elevated total cholesterol, LDL-cholesterol, apolipoprotein B & triglycerides & to increase HDL-cholesterol in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum triglyceride levels (Fredrickson type IV) & patients w/ dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Reduction of total cholesterol & LDL-cholesterol in patients w/ homozygous familial hypercholesterolemia when response to diet & other non-pharmacological measures are inadequate.
Dosage/Direction for Use
Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg.
May be taken with or without food: Avoid excessive consumption (>1 L daily) of grapefruit juice.
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3 times upper limit of normal. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Discontinue use if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Patients w/ acute, serious condition suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders & uncontrolled seizures). Immune-mediated necrotizing myopathy. Perform liver function tests prior to & semiannually thereafter. Avoid use w/ cyclosporine, fibric acid derivatives, erythromycin, niacin (≥1 g daily) or azole antifungals; immunosuppressive drugs, fusidic acid therapy; HIV PIs, hepatitis C PIs. Alcoholism, history of liver disease. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation.
Adverse Reactions
Insomnia; headache; nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence; myalgia; asthenia.
Drug Interactions
Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, niacin, erythromycin, azole antifungals. Decreased plasma conc w/ Mg & Al hydroxide-containing oral antacids, colestipol. Increased digoxin conc. Higher plasma conc w/ erythromycin. Increased AUC values of norethindrone & ethinyl estradiol. Severe myositis & myoglobinuria w/ fibrates.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Lipistad FC tab 10 mg
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