Rovas: Side Effects & Dosing

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 Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Rosuvastatin Ca

Indications/Uses

Prevention of CV events to reduce total mortality & risk of major CV events (CV death, stroke, MI, unstable angina or arterial revascularization) in adults w/ increased risk of ASCVD. Adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate for primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb); adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) or if such treatments are inappropriate for HoFH; slow or delay progression of atherosclerosis in adults w/ hypercholesterolaemia. Reduction of total cholesterol, LDL & Apo B in childn & adolescents 6-17 yr w/ heterozygous familial hypercholesterolaemia (HeFH).

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Dosage/Direction for Use

Statin naive patient or patient switched from another HMG CoA reductase inhibitor Initially 5 or 10 mg once daily. Adjust dose to 20 mg after 2-4 wk, if necessary. Patient w/ severe hypercholesterolaemia at high CV risk (in particular those w/ familial hypercholesterolaemia) who do not achieve treatment goal on 20 mg Double dose to 40 mg daily. HeFH Childn 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Patients w/ active liver disease including unexplained, persistent elevations in hepatic aminotransferase (transaminase) conc; myopathy. Concomitant administration w/ cyclosporin. Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation.

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Special Precautions

Myopathy & rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Patients w/ predisposing factors for myopathy (eg, advanced age ≥65 yr, renal impairment, inadequately treated hypothyroidism); history of liver disease (eg, chronic alcohol liver disease) &/or patients who consume substantial amounts of alcohol. Consider renal function assessment in patients w/ Child-Pugh scores 8 & 9. Child-Pugh score >9.

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Use In Pregnancy & Lactation

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Adverse Reactions

Abdominal pain, nausea; myalgia; asthenia, headache. Serious adverse effects eg, DM, high HbA1c level, impaired fasting glucose; pancreatitis; increased liver enzymes, liver failure; autoimmune necrotizing myopathy, muscle disorder, rhabdomyolysis, tendon rupture; acute renal failure, hematuria, proteinuria.

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Drug Interactions

Decreased peak plasma conc & AUC w/ antacid containing Al- & Mg hydroxide; erythromycin. Increased peak plasma conc & AUC w/ itraconazole. Increased risk of myopathy &/or rhabdomyolysis w/ colchicine; gemfibrozil. Increased plasma conc & risk of myopathy w/ cyclosporine. Increased both peak plasma conc & AUC of digoxin. Increased AUC of OCs (eg, norgestrel & estradiol).

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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.

Thai FDA Category

Presentation/Packing

Form

Rovas FC tab 10 mg

Packing/Price

3 × 10's

Form

Rovas FC tab 20 mg

Packing/Price

3 × 10's

Rovas

rosuvastatin

Manufacturer:

Community Pharm PCL

Distributor:

Community Pharm PCL

Marketer:

Community Pharm PCL