Xentor

Xentor

atorvastatin

Manufacturer:

ADP Pharma

Distributor:

ADP Pharma
Full Prescribing Info
Contents
Atorvastatin calcium.
Description
Each tablet contains: Atorvastatin (as Calcium) 20 mg or 40 mg.
Indications/Uses
It is used to reduce LDL-cholesterol apolipoprotein B, and triglycerides, and to increase HDL-cholesterol in the treatment of hyperlipidaemias, including hypercholesterolaemias and combined (mixed) hyperlipidaemia (type IIa or IIb hyperlipoproteinaemias) hypertriglyceridaemia (type IV) and dysbetalipoproteinaemia (type III), and as adjunctive therapy in patients with homozygous familial hypercholestrolaemia who have some LDL-receptor function.
Dosage/Direction for Use
The usual dose is 10 mg to 20 mg of atorvastatin once daily.
Initial dose of 40 mg daily may be used in patients who require a large reduction in LDL-cholesterol. The dose may be adjusted at intervals of 4 weeks up to a maximum of 80 mg daily.
Familial Hypercholesterolaemia: initially 10 mg daily, increases at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increases to a maximum of 80 mg once daily (or combined with anion exchanged resin in heterozygous familial hypercholesterolaemia).
Children and adolescents aged 10 to 17 with heterozygous familial hypercholesterolaemia may be given an initial dose of 10 mg once daily adjusted according to response to a maximum of 20 mg once daily. Or as prescribed by the physician.
Contraindications
Patients with known hypersensitivity to any component of this product.
Special Precautions
Atorvastatin should not be given to patients with acute liver disease or unexplained persistently raised serum aminotransferase concentrations. It should be avoided during pregnancy since there is a possibility that it could interfere with fetal sterol synthesis; there have been a few reports of congenital abnormalities associated with statins. It should be discontinued if marked or persistent increase in serum-amino transferase or creatinine phosphokinase concentration occur. It should be used with caution in patients with several renal impairment.
Adverse Reactions
The most common adverse effect of the therapy with atorvastatin and other statins are gastrointestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision, insomnia and dysgeusia. Reversible increase in serum aminotransferase concentrations may occur and liver function should be assessed before treatment is initiated and then monitored periodically until one year after the last evaluation in dose.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Tab 20 mg x 30's. 40 mg x 30's.
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