Ezetrol Tablet 10mg

Indications

Primary Hypercholesterolemia: Ezetrol co-administered with statin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia who are not appropriately controlled with a statin alone. Ezetrol monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia in whom a statin is considered inappropriate or is not tolerated.

Prevention of Cardiovascular Events: Ezetrol is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin.

Homozygous Familial Hypercholesterolaemia (HoFH): Ezetrol co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Homozygous Sitosterolemia (Phytosterolemia): Ezetrol is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolemia

Pharmacology

Ezetimibe localises at the brush border of the small intestine and inhibits absorption of cholesterol via the sterol transporter, Niemann-Pick C1-Like1 (NPC1L1). This results in decreased delivery of cholesterol to the liver, reduction of hepatic cholesterol stores and increased clearance of cholesterol from the blood.

Dosage & Administration

The recommended dose of Ezetimibe is 10 mg once daily. Ezetimibe can be administered with or without food.

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Interaction

Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in animals, Ezetrol increased cholesterol in the gallbladder bile. Coadministration of Ezetrol with fibrates is not therefore recommended until use in patients is studied.

Contraindications

Hypersensitivity to any component of this medication. The combination of Ezetimibe with an HMG-CoA reductase inhibitor is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.

Side Effects

Clinical studies of Ezetrol (administered alone or with an HMG-CoA reductase inhibitor) demonstrated that Ezetrol was generally well tolerated. The overall incidence of adverse events reported with Ezetrol was similar to that reported with placebo, and the discontinuation rate due to adverse events was also similar for Ezetrol and placebo.

Pregnancy & Lactation

There are no adequate and well-controlled studies of Ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus

Precautions & Warnings

Exclude or treat secondary causes of dyslipidaemia prior to initiating therapy. Renal and hepatic impairment. Pregnancy and lactation.

Use in Special Populations

Pediatric Use-

10 to 17 years: No dosage adjustment is required. The clinical experience in pediatric and adolescent patients is however limited. When Ezetrol is administered with statin, the dosage instructions for statin, in adolescents should be consulted.

Children < 10 years: Ezetrol is not recommended for use in children below age 10 due to insufficient data on safety and efficacy.

Overdose Effects

No cases of overdosage with Ezetrol have been reported. Administration of Ezetrol,

50 mg/day, to 15 subjects for up to 14 days was generally well tolerated. In the event of

an overdose, symptomatic and supportive measures should be employed.

Therapeutic Class

Ezetimibe

Storage Conditions

Store in a cool & dry place protected from light and moisture. Keep out of reach of children.