Rosuvapac Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Side Effects Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Rosuvastatin

Indications/Uses

Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. Homozygous familial hypercholesterolaemia as an adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate. 5-mg tab: Prevention of major CV events in patients estimated to be at high risk for a 1st CV event, as an adjunct correction of other risk factors.

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Dosage/Direction for Use

Initially 5 or 10 mg once daily in both statin-naive or patient switched from another HMG-CoA reductase inhibitor. May be adjusted to the next dose level after 4 wk if necessary. Patient w/ severe hypercholesterolaemia at high CV risk (w/ familial hypercholesterolaemia) Max dose: 40 mg. Childn & adolescent 10-17 yr (boy Tanner stage II & above & girl at least 1 yr post-menarche) w/ heterozygous familial hypercholesterolaemia Initially 5 mg daily. Usual dose range: 5-20 mg once daily. Elderly, Asians, moderate to renal impairment Recommended starting dose: 5 mg. Prevention of CV event 20 mg daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Active liver disease (including unexplained, persistent elevations of serum transaminases & elevation >3x the ULN). Severe renal impairment (CrCl <30 mL/min). 10- & 20-mg tab: Hypersensitivity. Myopathy. Patients receiving concomitant ciclosporin.

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Special Precautions

5-mg tab: 40 mg dose is contraindicated in Asians & patients w/ moderate renal impairment & predisposing factors to myopathy. Not recommended in childn <10 yr. 10- & 20-mg tab: Proteinuria; consider assessment of renal function during routine follow-up of patients treated w/ 40 mg. Myalgia, myopathy & rhabdomyolysis. In combination w/ ezetimibe.

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Adverse Reactions

10- & 20-mg tab: Headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.

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

Rosuvapac FC tab 10 mg

Packing/Price

3 × 10's

Form

Rosuvapac FC tab 20 mg

Packing/Price

3 × 10's

Form

Rosuvapac FC tab 5 mg

Packing/Price

3 × 10's

Rosuvapac

rosuvastatin

Manufacturer:

Pacific Pharma

Distributor:

AA Medical