Clinical Pharmacology Details


EZETIMIBE + SIMVASTATIN


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Indications & Dose:


Adults:


Hypercholesterolaemia:


Usually 1 tab 10/20mg as single dose in evening. Adjust at min. 4 week intervals according to response; max 10mg ezetimide and 80mg simvastatin daily.


Homozygous familial hypercholesterolaemia:


10mg ezetimide and 40mg simvasatin or 10mg ezetimide and 80mg simvasatin as a single dose in evening.


Children: Not recommended

Contraindications:

Active liver disease moderate or severe liver impairment. Pregnancy, lactation

Side Effects:

Cautions:

Precautions:

Severe renal impairment, Perform liver function tests before and during treatment withdraw if ALT or AST > 3 x ULN. History of liver disease. Advise patients to report unexplained muscle weakness or pain; monitor creatine kinase levels, withdraw if >5 x ULN. Renal impairment, hypothyroidism, history of muscle toxicity, family or personal history of muscle disorders, alcohol abuse, elderly (>70 years); monitor creatine kinase levels prior to treatment, do not treat at >5xULN.


 

Interaction:

Digoxin, coumarin anticoagulants, ciclosporin, danazol, amidoarone, verapamil, diltiazem, erythromycin, clarithromycin, telithromycin, itraconazole, ketoconazole, other CYP3A4 inhibitors, immunosuppressants, nefazodone, protease inhibitors, grapefruit juice, colestipol, colestyramine

Warnings:

Adverse Effects:

Headache, flatulence, myalgia, abdominal pain, diarrhoea, fatigue

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: