Vytorin Dosage & Drug Information

Concise Prescribing Info

Contents

Cap 10/10 mg: Ezetimibe 10 mg, simvastatin 10 mg. Cap 10/20 mg: Ezetimibe 10 mg, simvastatin 20 mg

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Indications/Uses

Adjunctive therapy to diet for the reduction of elevated total-cholesterol, LDL-C, Apo B, triglycerides & non-HDL-C, & to increase HDL-C in patients w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia. Reduction of elevated total-C & LDL-C levels in patients w/ HoFH as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.

Dosage/Direction for Use

Individualized dosage taken as a single dose in the evening. Usual starting dose: 10/20 mg daily. Patient requiring less aggressive LDL-C reductions Initially 10/10 mg daily may be considered. Patient w/ CKD & estimated GFR <60 mL/min/1.73 m² 10/20 mg daily. Patient taking amiodarone, verapamil, diltiazem, elbasvir or grazoprevir Max daily dose: 10/20 mg.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Concomitant administration w/ potent CYP3A4 inhibitors, gemfibrozil, cyclosporine, or danazol. Active liver disease or unexplained persistent serum transaminase elevations. Pregnancy & lactation.

MIMS Class

Dyslipidaemic Agents

ATC Classification

C10BA02 - simvastatin 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

Vytorin 10/10 mg tab

Packing/Price

1's

Form

Vytorin 10/20 mg tab

Packing/Price

1's

Vytorin

ezetimibe + simvastatin

Manufacturer:

Organon