Zetlow-10 Dosage & Drug Information

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 Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ezetimibe

Indications/Uses

Adjunctive therapy to diet for use in patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia who are not appropriately controlled w/ statin alone. Adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, & non-HDL-C in patients w/ primary heterozygous familial & nonfamilial hyperlipidemia as monotherapy, in combination w/ statins or fenofibrate in adult patients w/ mixed hyperlipidemia. Adjunctive therapy to other lipid lowering treatments or if such treatments are unavailable for the reduction of elevated total-C & LDL-C levels in patients w/ HoFH.

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Dosage/Direction for Use

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 or unexplained persistent elevations in hepatic transaminase levels. Women who are pregnant or may become pregnant. Nursing mothers.

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Special Precautions

Concurrent use w/ a specific statin or fenofibrate. Consider w/drawal should an increase in ALT or AST ≥3 x ULN persist. Discontinue if myopathy is diagnosed or suspected. Not recommended in patients w/ moderate to severe hepatic & renal impairment. Pregnancy. Lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Liver enzyme abnormalities; rhabdomyolysis & myopathy. URTI, diarrhea, arthralgia. Monotherapy: Sinusitis & pain in extremity. Combination w/ statins: Nasopharyngitis, myalgia.

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Drug Interactions

Increased exposure to cyclosporin. Cholelithiasis w/ fibrates, fenofibrates. Monitor INR when combined w/ warfarin.

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Storage

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Description

View Zetlow-10 description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Zetlow-10 tab 10 mg

Packing/Price

70's (P1,697.5/box)

Zetlow-10

ezetimibe

Manufacturer:

Torrent

Distributor:

Torrent