Lipidef

Atorvastatin Ca trihydrate

Adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apo-B & triglycerides in patients w/ primary hypercholesterolemia, combined or mixed hyperlipidemia & heterozygous & homozygous familial hypercholesterolemia when response to diet & other nonpharmacological measures are inadequate. Prevention of CV complications.

Usual dose: 10 mg once daily. Usual dosage range: 10-80 mg once daily. Primary hypercholesterolemia & combined or mixed hyperlipidemia 10 mg daily for 2 wk & up to 4 wk for max response. Homozygous familial hypercholesterolemia 80 mg. Heterozygous familial hypercholesterolemia in ped patients 10-17 yr 10 mg daily. Max dose: 20 mg daily. Adjustments should be made at ≥4 wk intervals.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3 x ULN. Pregnancy & lactation.

Hepatic effects: LFTs should be performed prior to initiation of treatment, 12 wk following both the initiation therapy & any evaluation of dose & periodically thereafter. Monitor for creatine phosphokinase & transaminase elevations. Avoid alcohol consumption. Skeletal muscle effects: Myalgia. Increased risk of myopathy in concurrent administration w/ cyclosporine, fibric acid derivatives, erythromycin, niacin or azole antifungals. Temporary suspension of atorvastatin may be appropriate during fusidic acid therapy. Hemorrhagic stroke. Ensure appropriate diet, exercise & wt reduction in obese patients & treat underlying medical problems before atorvastatin therapy.

Insomnia, headace, nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence, myalgia, arthralgia, asthenia, hypoglycemia, hyperglycemia, anorexia, peripheral neuropathy, paresthesia, tinnitus, pancreatitis, vomiting, hepatitis, cholestatic jaundice, alopecia, pruritus, rash, urticarial myopathy, myositis, muscle cramps, impotence, angioneurotic edema, malaise, angina.

Risk of myopathy increased w/ concurrent administration of cyclosporin, fibric acid derivatives, niacin or CYP450 3A4 inhibitors (eg, erythromycin, azole antifungals). Diltiazem HCl can increase plasma conc of atorvastatin. Cimetidine, CYP450 3A inducers: efavirenz, rifampin. Antipyrine, azithromycin, warfarin, amlodipine, fusidic acid, other concomitant therapy. Decreased atorvastatin plasma conc w/ oral antacid susp containing Mg & Al hydroxides, & colestipol. Increased atorvastatin plasma conc w/ erythromycin/clarithromycin.

Dyslipidaemic Agents

C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

G