Suvezen Dosage & Drug Information

Concise Prescribing Info

Contents

Rosuvastatin, ezetimibe

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Indications/Uses

Adjunct to diet for primary hypercholesterolaemia (heterozygous familial & non-familial) or homozygous familial hypercholesterolaemia in adult patients who are not appropriately controlled w/ statin alone, or who are adequately controlled w/ rosuvastatin & ezetimibe given concurrently at the same dose level as in fixed combination but as separate products.

Dosage/Direction for Use

Individualized dosing. Recommended dose: 1 FC tab daily. Co-administartion w/ bile acid sequestrants Suvezen dosing should occur ≥2 hr before or ≥4 hr after bile acid sequestrant administration. Patient w/ c.521CC or c.421AA genotype Max: 20 mg once daily. Moderate renal impairment (CrCl <60 mL/min); patient of asian ancetsry; or those w/ predisposing factors to myopathy Recommended starting dose: Rosuvastatin 5 mg.

Administration

May be taken with or without food: Swallow whole w/ water.

Contraindications

Hypersensitivity. Myopathy. Concomitant use w/ ciclosporin. Active liver disease or unexplained persistent elevations in serum transaminases (including any >3 x ULN). Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

MIMS Class

Dyslipidaemic Agents

ATC Classification

C10BA06 - rosuvastatin and ezetimibe ; Belongs to the class of HMG CoA reductase inhibitors in combination with other lipid modifying agents. Used in the treatment of hyperlipidemia.

Regulatory Classification

POM

Presentation/Packing

Form

Suvezen FC tab 10 mg/10 mg

Packing/Price

1's

Form

Suvezen FC tab 20 mg/10 mg

Packing/Price

1's

Suvezen

Manufacturer:

Sanofi Ilac Sanayi