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RXDRUG-DRP-5155-01-1pc

SAATIN 20 Atorvastatin Calcium 20mg Film-Coated Tablet 1's

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Description

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.

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.

Administration

May be taken with or without food.

Contraindications

Atorvastatin should be avoided during pregnancy since there is possibility that it 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 & Lactation

Atorvastatin should be avoided during pregnancy since there is a possibility that it 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.

Action

Pharmacology: Pharmacodynamics and Pharmacokinetics: Atorvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (or statin), is a lipid regulating drug with 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 contribution of the active metabolites. Atorvastatin is excreted as metabolites, primarily in the bile.

MedsGo Class

Dyslipidaemic Agents

Features

Brand
Saatin
Full Details
Dosage Strength
20mg
Drug Ingredients
  • Atorvastatin
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Atorvastatin Calcium
Dosage Form
Film-Coated Tablet
Registration Number
DRP-5155-01
Drug Classification
Prescription Drug (RX)
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