Ezetrol 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 Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ezetimibe

Indications/Uses

Adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, triglycerides, & non-HDL-C & to increase HDL-C in adult & adolescent (10-17 yr) w/ primary heterozygous familial & non-familial hypercholesterolemia. Reduction of the risk of CV events (CV death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients w/ CHD, CKD. Reduction of elevated total-C & LDL-C levels in adult & adolescent (10-17 yr) w/ HoFH. Reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia.

Click to view Ezetrol detailed prescribing information

Dosage/Direction for Use

Patient w/ primary hypercholesterolemia 10 mg once daily, alone or in combination w/ statin or fenofibrate. Combination therapy in patient w/ CHD 10 mg. Renal impairment/CKD Monotherapy: No dosage adjustment necessary. Combination therapy w/ simvastatin in patient w/ CKD & estimated GFR approx <60 mL/min/1.73 m² Ezetrol 10 mg & simvastatin 20 mg once daily in the evening.

Click to view Ezetrol detailed prescribing information

Overdosage

View Ezetrol overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

Click to view Ezetrol detailed prescribing information

Special Precautions

Perform LFT at initiation of therapy. Discontinue if myopathy or any unexplained muscle pain, tenderness or weakness develops during concomitant use w/ statin. Not recommended for co-administration w/ fibrates other than fenofibrate. Consider alternative lipid-lowering therapy if cholelithiasis is suspected w/ concomitant use w/ fenofibrate. Monitor cyclosporine conc; INR if administered w/ warfarin or fluindione. Moderate or severe hepatic insufficiency. Caution when prescribing to pregnant women. Not to be used during lactation. Not recommended in childn <6 yr.

Click to view Ezetrol detailed prescribing information

Use In Pregnancy & Lactation

Click to view Ezetrol detailed prescribing information

Adverse Reactions

Monotherapy: Abdominal pain, diarrhea, flatulence; fatigue. Combination therapy w/ statin: Increased ALT &/or AST; headache; myalgia. Combination therapy w/ fenofibrate: Abdominal pain.

Drug Interactions

Decreased absorption w/ antacids. Decreased mean AUC w/ cholestyramine; increased mean AUC w/ cyclosporine. Not recommended w/ fibrates (other than fenofibrate). Increased INR w/ warfarin & fluindione.

Click to view Ezetrol detailed prescribing information

Storage

View Ezetrol storage conditions for details to ensure optimal shelf-life.

Description

View Ezetrol description for details of the chemical structure and excipients (inactive components).

Action

View Ezetrol mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Dyslipidaemic Agents

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Ezetrol tab 10 mg

Packing/Price

30's (P1,254/pack)

Ezetrol

ezetimibe

Manufacturer:

MSD International GmBH (Puerto Rico)

Distributor:

Organon