Hepatic impairment; patients consuming substantial quantities of alcohol with a history of liver disease. Not recommended for use in children <10 yr.
Lactation: Because of the potential for adverse reactions in nursing infants, women taking this drug should not breast feed. Contraindicated in breastfeeding women.
Indication
Hypercholesterolaemia, Primary Hyperlipidemia
Contra Indication
Hypersensitivity; active liver disease or unexplained persistent elevated liver function tests. Pregnancy and lactation.
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Mode of Action
Atorvastatin competitively inhibits HMG-CoA reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonate which is an early rate-limiting step in cholesterol biosynthesis. Ezetimibe inhibits the absorption of cholesterol from the intestine, thus decreasing the delivery of intestinal cholesterol to the liver.
Interaction
Atorvastatin: Increases digoxin levels; increases anticoagulant effect of warfarin. Avoid the combination of HMG-CoA reductase inhibitors and fibrates. Ezetimibe: Cholestyramine decreases AUC of ezetimibe by approx 55%; ciclosporin may increase ezetimibe levels.
Potentially Fatal: Antacids decrease atorvastatin levels; colestipol decreases atorvastatin plasma levels; propranolol decreases antihyperlipidaemic activity of atorvastatin.
Pregnancy Category Note
Pregnancy Category: X
Lactation: Because of the potential for adverse reactions in nursing infants, women taking this drug should not breast feed. Contraindicated in breastfeeding women.
Adult Dose
Oral
Hypercholesterolaemia
Adult: Per tablet contains atorvastatin 10 mg and ezetimibe 10 mg: Usual starting: 1 tablet once daily.
Child Dose
Safety and efficacy not established
Renal Dose
N/A
Administration
May be taken with or without food.
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