Otagil Dosage & Drug Information

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 >3x ULN). Pregnancy & lactation.

Special Precautions

Abnormal liver function. Perform LFT 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 ULN) or if diagnosed w/ myopathy.

Adverse Reactions

Headache, confusion, diabetes, elevated ALT (>3 ULN), muscle pain, myopathy, rhabdomyolysis, proteinuria, hypersensitivity (eg, angioedema, rash, urticaria), serum alkaline phosphatase elevation.

View ADR Monitoring Form

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.

MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Thai FDA Category

Presentation/Packing

Form

Otagil tab 10 mg

Packing/Price

30's

Form

Otagil tab 20 mg

Packing/Price

30's

Otagil

rosuvastatin

Manufacturer:

Unison

Distributor:

Medline

Marketer:

Medline