Rozuace 20 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Rosuvastatin

Indications/Uses

Primary hypercholesterolaemia & mixed dyslipidaemia resistant to dietary measures. As adjunct to other lipid-lowering treatments in homozygous familial hypercholesterolaemia.

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Dosage/Direction for Use

Initially 10 mg once daily, may be adjusted to 20 mg after 4 wk if necessary. Dose of 40 mg may only be considered in patient w/ severe hypercholesterolaemia at high CV risk.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & elevation >3x the ULN; myopathy. Severe renal impairment (CrCl <30 mL/min). Patients receiving concomitant cyclosporin. Pregnancy & lactation.

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Special Precautions

Not to be used in patient w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders or uncontrolled seizures). Dizziness may occur which may affect ability to drive & use machines.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache, dizziness, constipation, nausea, abdominal pain, asthenia, pruritus, rash & urticaria.

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Drug Interactions

Increased AUC w/ cyclosporin. May increase INR w/ vit K antagonist eg, warfarin. Increased C_max & AUC w/ gemfibrozil. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC_0-t & C_max w/ erythromycin. Increased AUC of ethinyl estradiol & norgestrel. Increased risk of myopathy w/ gemfibrozil, other fibrates & lipid-lowering doses (>1 g daily) of niacin.

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Storage

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Description

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Action

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MIMS Class

Dyslipidaemic Agents

ATC Classification

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

Regulatory Classification

POM

Presentation/Packing

Form

Rozuace 20 FC tab 20 mg

Packing/Price

1 × 10's

Rozuace 20

rosuvastatin

Manufacturer:

Agio Pharma

Distributor:

Ashro

Marketer:

Ashro