Atorcad

Atorcad

atorvastatin

Manufacturer:

Hizon

Distributor:

Pharma Dynamic
Full Prescribing Info
Contents
Atorvastatin calcium.
Description
Each film-coated tablet contains: Atorvastatin (as Calcium) 20 mg.
Action
Pharmacology: Pharmacodynamics & Pharmacokinetics: Atorvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (or statin), is a lipid regulating drug actions on plasma lipids.
Atorvastatin is rapidly absorbed from the gastrointestinal tract. It has low absolute bioavailability of about 12% due to presystemic clearance in the gastrointestinal mucosa and/or first pass metabolism in the liver, its primary site of action. Atorvastatin is metabolized by the cytochrome P450 isoenzyme CYP3A4 to a number of active metabolites. It is 98% bound to plasma proteins. The mean plasma elimination half-life of atorvastatin is about 14 hours although the half-life of inhibitory activity for HMG-COA reductase is about 20 to 30 hours due to the contribution of the active metabolites. Atorvastatin is excreted as metabolites, primarily in the bile.
Indications/Uses
It is used to reduce LDL-Cholesterol, apolipoprotein B, and triglycerides and to increase HDL-Cholesterol in the treatment of hyperlipidaemias (type IIa or IIb hyperlipoproteinaemias), hypertriglyceridaemia (type IV), and dysbetalipoproteinaemia (type III).
Dosage/Direction for Use
The usual initial dose is 10 to 20 mg of atorvastatin once daily; an 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 or as prescribed by the physician.
Overdosage
There is no specific treatment for atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Contraindications
Atorvastatin should be avoided during pregnancy since there is possibility that they could interfere with fetal sterol synthesis.
Special Precautions
It should not be given to patients with active liver disease. Liver function should be assessed before starting treatment and subsequently when clinically indicated; additional assessment after 3 months and before and after dosage increases has been advised for some statins, particularly when high doses are given. It should be used with caution in patients with renal impairment as the risk of myopathy is increased. It should be stopped if creatine phosphokinase increases significantly or if myopathy is diagnosed.
Use in Pregnancy: Atorvastatin should be avoided during pregnancy since there is possibility that they could interfere with fetal sterol synthesis; there have been a number of reports of congenital abnormalities associated with statins.
Use In Pregnancy & Lactation
Pregnancy: Atorvastatin should be avoided during pregnancy since there is possibility that they could interfere with fetal sterol synthesis; there have been a number of reports of congenital abnormalities associated with statins.
Adverse Reactions
The most common adverse effects of therapy with atorvastatin and other statins are gastrointestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision, insomnia and dysgeusia. Hypersensitivity reactions including anaphylaxis and angioedema have also occurred.
Drug Interactions
Interactions may occur with drugs that inhibit the cytochrome P450 isoenzyme CYP3A4 including ciclosporin, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV-protease inhibitors, nefazodone, danazol, amiodarone and verapamil. There may also be similar interaction with grapefruit juice.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
FC tab (white to off-white, oblong, biconvex, plain on both sides) 20 mg x 100's.
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