Auritz

Auritz

rosuvastatin

Manufacturer:

Mega Lifesciences

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
As adjunctive therapy to diet to reduce elevated total-C, Apo-B, non-HDL & triglycerides & to increase HDL-C in adult w/ primary hyperlipidemia or mixed dyslipidemia; in ped patients 10-17 yr w/ heterozygous familial hypercholesterolemia. Adjunctive therapy to diet for the treatment of adult w/ hypertriglyceridemia. Adjunct to diet for the treatment of primary dysbetalipoproteinemia (type III hyperlipoproteinemia). Adjunctive therapy to other lipid-lowering treatment or alone in adult w/ homozygous familial hypercholesterolemia. Adjunctive therapy to diet to slow the progression of atherosclerosis in adult as part of a treatment strategy to lower total-C & LDL-C to target levels.
Dosage/Direction for Use
Dose range: 5-40 mg once daily. Hyperlipidemia, mixed dyslipidemia, hypertriglyceridemia, primary dysbetalipoproteinemia (type III hyperlipoproteinemia) & slowing of the progression of atherosclerosis 10 mg once daily. Heterozygous familial hypercholesterolemia in ped patients (10-17 yr) 5-20 mg/day. Max: 20 mg/day. Adjustment dose at intervals of ≥4 wk. Homozygous familial hypercholesterolemia 20 mg. Use w/ cyclosporine or lopinavir/ritonavir 5 mg. Max: 10 mg. Concomitant lipid-lowering therapy 10 mg daily. Severe renal impairment 5 mg once daily. Max: 10 mg. All doses to be taken once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease. Pregnancy & lactation.
Special Precautions
Patients w/ predisposing factors for myopathy. Perform liver enzyme tests prior to & periodically thereafter. Excessive alcohol consumption. Preexisting or history of chronic liver disease. Dose reduction for patients w/ unexplained persistent proteinuria &/or hematuria during routine urinalysis testing. Severe renal impairment. May impair ability to drive or operate machinery. Childn & elderly.
Adverse Reactions
Rhabdomyolysis w/ myoglobinuria & acute renal failure & myopathy (including myositis); liver enzyme abnormalities. Headache, myalgia, abdominal pain, asthenia, nausea.
Drug Interactions
Cyclosporin, gemfibrozil, lopinavir, ritonavir, coumarin anticoagulants, niacin, fenofibrate.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Auritz FC tab 10 mg
Packing/Price
3 × 10's
Form
Auritz FC tab 20 mg
Packing/Price
3 × 10's
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