Rovex 10/Rovex 20 Dosage & Drug Information

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

Concise Prescribing Info

Contents

Rosuvastatin Ca

Indications/Uses

Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidemia (type IIb) as adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. HoFH as adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate.

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Dosage/Direction for Use

Individualised dosage. Statin-naïve or patient switched from another HMG CoA reductase inhibitor Initially 5 or 10 mg once daily. Dose adjustment to next level can be made after 4 wk. Final titration to max dose of 40 mg should only be considered in patients w/ severe hypercholesterolaemia & high CV risk (particularly those w/ familial hypercholesterolaemia), who do not achieve treatment goal on 20 mg & in whom routine follow-up will be performed. Elderly >70 yr, moderate renal impairment (CrCl <60 mL/min), Asian & patient w/ predisposing factor to myopathy Initially 5 mg.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Patients w/ myopathy. Concomitant use w/ ciclosporin. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation exceeding 3 x ULN. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation. 40-mg dose: Patients w/ predisposing factors for myopathy/rhabdomyolysis eg, moderate renal impairment (CrCl <60 mL/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where increase in plasma levels may occur, Asian patients, concomitant use of fibrates.

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Special Precautions

Discontinue use if CK levels are markedly elevated (>5 x ULN) or muscular symptoms are severe & cause daily discomfort. Skeletal muscle effects eg, myalgia, myopathy & rarely rhabdomyolysis. Assess renal function during routine follow-up of patients treated w/ 40-mg dose. Do not measure creatinine kinase following strenuous exercise or in presence of a plausible alternative cause of CK increase. Not recommended in childn.

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Adverse Reactions

Headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.

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Drug Interactions

Increased AUC values w/ ciclosporin. May result in increased INR w/ vit K antagonists eg, warfarin or another coumarin anticoagulant. Potential pharmacodynamic interaction w/ ezetimibe; fenofibrate. Increased AUC & C_max w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid-lowering doses (≥1 g daily) of niacin (nicotinic acid). Exposure may be strongly increased w/ PIs. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC_(0-t) & C_max w/ erythromycin. Increased AUC of ethinyl estradiol & norgestrel & potentially HRT.

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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

Presentation/Packing

Form

Rovex 10 FC tab 10 mg

Packing/Price

30's

Form

Rovex 20 FC tab 20 mg

Packing/Price

30's

Rovex 10/Rovex 20

rosuvastatin

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma