Otagil

Otagil

rosuvastatin

Manufacturer:

Unison

Distributor:

Medline

Marketer:

Medline
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Prevention of CV event in adult. Adjunct to diet in heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, hyperlipidemia, mixed dyslipidemia, hypertriglyceridemia & primary dysbetalipoproteinemia (type III).
Dosage/Direction for Use
Individualized dose. 10 mg or 20 mg once daily. May be adjusted to 40 mg if 20 mg dose does not achieve goal.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease (serum transaminase elevation >3 x ULN). Pregnancy & lactation.
Special Precautions
Abnormal liver function. Perform liver function test before & 6 & 12 wk after initiation of therapy & periodically thereafter. Concomitant use w/ alcohol or liver disease history. Microscopic hematuria & proteinuria may occur especially w/ 40 mg dose. Evaluate renal function during routine follow-up & consider dose adjustment in patient w/ symptoms. May cause rhabdomyolysis w/ acute renal failure or myopathy. Discontinue if CPK is elevated (>10 UNL) or if diagnosed w/ myopathy.
Adverse Reactions
Headache, confusion, diabetes, elevated ALT (>3 UNL), muscle pain, myopathy, rhabdomyolysis, proteinuria, hypersensitivity (eg, angioedema, rash, urticaria), serum alkaline phosphatase elevation.
Drug Interactions
Contraindicated w/ systemic fusidic acid, gemfibrozil, ledispavir & red yeast rice. Increase serum conc of daptomycin, pazopanib, trabectedin, vit K antagonists. Increased serum conc w/ acipimox, amiodarone, bezafibrate, boceprevir, ciprofibrate, clopidogrel, colchicines, systemic cyclosporine, dronedarone, elthrombopag, fenofibrate, systemic fusidic acid, gemfibrozil, itraconazole, ledipasvir, niacinamide, paritaprevir, PIs, raltegravir, simeprevir, telaprevir, teriflunomide.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Otagil tab 10 mg
Packing/Price
30's
Form
Otagil tab 20 mg
Packing/Price
30's
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