Zettrol

Zettrol

ezetimibe

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Concise Prescribing Info
Contents
Ezetimibe
Indications/Uses
Alone or in combination w/ HMG-CoA reductase inhibitor (statin) as adjunctive therapy to diet for reduction of elevated total cholesterol (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. In combination w/ fenofibrate as adjunctive therapy to diet for reduction of elevated total-C, LDL-C, Apo B & non-HDL-C in adults w/ mixed hyperlipidemia. Administered w/ statin to reduce risk of CV events (CV death, non-fatal MI & stroke, unstable angina hospitalization, or need for revascularization) in patients w/ CHD; for reduction of elevated total-C & LDL-C levels in adult & adolescent 10-17 yr w/ HoFH. Administered w/ simvastatin to reduce risk of major CV events in patients w/ CKD. Adjunct to diet for reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia.
Dosage/Direction for Use
Recommended dose: 10 mg daily. In combination w/ statin: Continue to use either the usual initial or established higher statin dose. CHD & acute coronary syndrome event history 10 mg + statin w/ proven CV benefit. Co-administration w/ bile acid sequestrants: Administer either ≥2 hr before or ≥4 hr after bile acid sequestrant.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent serum transaminase elevations. Pregnancy & lactation when co-administered w/ statin.
Special Precautions
Discontinue use immediately if myopathy is suspected based on muscle symptoms or confirmed (creatine phosphokinase level >10x ULN). Myopathy & rhabdomyolysis. Perform LFTs when co-administered w/ statin at initiation of therapy & according to recommendations of the statin. Monitor ciclosporin conc w/ concomitant use; INR if added to warfarin, another coumarin anticoagulant, or fluindione. Discontinue therapy if cholelithiasis is suspected when used w/ fenofibrate. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended in patients w/ moderate (Child-Pugh score 7-9) or severe (Child-Pugh score >9) liver dysfunction. Pregnancy. Not to be used during lactation. Childn & adolescents ≤17 yr.
Adverse Reactions
Headache; abdominal pain, diarrhoea, flatulence; myalgia; fatigue; increased ALT &/or AST.
Drug Interactions
Decreased mean AUC w/ cholestyramine. Possible risk of cholelithiasis & gallbladder disease w/ fenofibrate. Increased mean AUC w/ ciclosporin. Increased INR w/ warfarin or fluindione.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Presentation/Packing
Form
Zettrol tab 10 mg
Packing/Price
10 × 10's
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