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Bestatin

Bestatin

atorvastatin

Manufacturer:

Umedica Labs

Distributor:

Littman
Full Prescribing Info
Contents
Atorvastatin calcium.
Description
Each film-coaled tablet contains: Atorvastatin Calcium equivalent to Atorvastatin 20 mg/40 mg, Excipients q.s.
Action
Pharmacology: Pharmacokinetics: Atorvastatin is rapidly absorbed after oral administration, maximum plasma levels occur within 1 to 2 hours. Although food reduces the rate and extent of absorption, LDL-C reduction is similar whether Atorvastatin is given with or without food. Atorvastatin is approximately 98% bound to plasma proteins. Atorvastatin is extensively metabolized and eliminated primarily in bile. The mean plasma elimination half life of Atorvastatin in humans is approximately 14 hours, but the half life of inhibitory activity for HMG-CoA reductase is 20-30 hours.
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 also can be effective as adjunct therapy in patients with homozygous familial hyper-cholesterolaemia 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.
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.
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 increases in serum-amino transferases or creatine phosphokinase concentrations occur. It should be used with caution in patients with severe renal impairment.
Use In Pregnancy & Lactation
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.
Adverse Reactions
The commonest adverse effects of therapy with atorvastatin and other statins are gastro-intestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision, insomnia and dysgeusia. Reversible increases in serum aminotransferase concentrations may occur and liver functions should be assessed before treatment is initiated and then monitored periodically until one year after the last elevation in dose.
Drug Interactions
There is increased risk of myopathy if certain drugs are given concurrently with statins. Concomitant administration of drugs that inhibit the cytochrome P450 isoenzyme CYP3A4, such as ciclosporin, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV-protease inhibitors, and nefazodone, might produce high plasma levels of atorvastatin, thus increasing the risk of myopathy.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Bestatin FC tab 20 mg
Packing/Price
50's (P900/box)
Form
Bestatin FC tab 40 mg
Packing/Price
50's (P1,117/box)
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