Ezetimibe TEVA

Ezetimibe TEVA

ezetimibe

Manufacturer:

Watson Pharma

Distributor:

Pacific Healthcare

Marketer:

Teva Pharma
Concise Prescribing Info
Contents
Ezetimibe
Indications/Uses
Adjunct to diet in heterozygous familial & non-familial primary hypercholesterolaemia, in combination w/ HMG-CoA reductase inhibitor (statin) in patients who are not appropriately controlled w/ statins alone, or as monotherapy in whom statin is considered inappropriate or not tolerated; HoFH in combination w/ statin; homozygous familial sitosterolaemia (phytosterolaemia). Risk reduction of CV events in patients w/ CHD & history of acute coronary syndrome (ACS) in addition to on-going statin therapy or initiated concomitantly w/ statin.
Dosage/Direction for Use
10 mg daily. Coadministration w/ bile acid sequestrants Dosing should occur either ≥2 hr before or ≥4 hr after bile acid sequestrant administration.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. In concomitant use w/ statin: Active liver disease or unexplained persistent serum transaminase elevations; pregnancy & lactation.
Special Precautions
Discontinue immediately if myopathy is suspected based on muscle symptoms or is confirmed by creatine phosphokinase level >10x ULN; in suspected cholelithiasis in combination w/ fenofibrate. Myopathy & rhabdomyolysis. Perform LFTs at initiation of therapy & according to recommendations of the statin. Monitor INR if used concomitantly w/ warfarin, another coumarin anticoagulant, or fluindione. Concomitant use w/ ciclosporin. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Not recommended in moderate (Child Pugh score 7-9) to severe (Child Pugh score >9) hepatic impairment. Pregnancy. Not to be used during lactation. Paed patients <6 yr; 10-17 yr w/ simvastatin dose >40 mg daily; <10 yr w/ simvastatin.
Adverse Reactions
Monotherapy: Abdominal pain, diarrhea, flatulence; fatigue. In combination w/ statin: Headache; myalgia; increased ALT &/or AST.
Drug Interactions
Decreased mean AUC w/ colestyramine. Possible risk of cholelithiasis & gallbladder disease w/ fenofibrate. Increased total conc w/ fenofibrate or gemfibrozil. Concomitant use 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
Ezetimibe TEVA tab 10 mg
Packing/Price
3 × 10's
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