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Atostin (Atorvastatin USP)

COMPOSITION:

Atostin 10 Tablet: Each film coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 10 mg.

Atostin 20 Tablet: Each film coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 20 mg.

PHARMACOLOGY:

Atostin is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentration occur within 1 to 2 hours. The absolute bioavailability of Atorvastatin is about 12%. The mean plasma elimination half Iife is about 14 hours although the half-life of inhibitory activity for HMG-CoA reductase is approximately 20 to 30 hours because of active metabolites. lts plasma protein binding is 98% and excreated as metabolites, primarily in the bile.

INDICATION:

Atostin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apolipoprotein B, and triglycerides (TG) levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; as an adjunct to diet for the treatment of patients with elevated serum triglycerides (TG) levels; for the treatment of patients with primary dysbetalipoproteinemia who do not respond adequately to diet; to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia; as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

Prior to initiating therapy with Atorvastatin, secondary cause for hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephritic syndrome, dysproteinemia, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.

DOSAGE AND ADMINISTRATION:

Patient should be placed on a standard cholesterol-lowering diet before receiving Atostin and should continue on this diet during treatment with Atostin . The usual starting dose for all the indications is 10 mg once daily. The dosage range is 10 to 80 mg once daily. Doses should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. Adjustment of dosage should be made at intervals of 4 weeks or more. Doses may be given at anytime of day with or without food.

Children: Treatment experience in a pediatric population with dose of Atostin up to 80 mg/day is limited. Geriatric Use: The safety and efficacy of Atostin in this population is as similar as < 70 years of age patient with the dose upto 80 mg/day. Patients with renal insufficiency: Dosage adjustment is not required.

USE IN PREGNANCY & LACTATION:

Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered by pregnant women. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers. Atorvastatin should be administered by women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus. Because of the potential for adverse reactions in nursing infants, women taking Atorvastatin should not breast-feed.

SIDE EFFECT:

Atorvastatin is generally well tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to Atorvastatin were constipation, flatulence, dyspepsia, and abdominal pain.

CONTRAINDICATION:

Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases.

PRECAUTION:

Before instituting therapy with Atorvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems. Information for patients: Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

DRUG INTERACTION:

The risk of myopathy during treatment with other drugs in this class is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals, or niacin (nicotinic acid). These risks may also occur when combining these drugs with Atorvastatin. No clinically significant interactions were observed when Atorvastatin was administered with antihypertensives and/or hypoglycemic agents. Caution should also be exercised when Atorvastatin is administered with inhibitors of p450 3a4 (macrolide antibiotics and azole antifungals). The effect of inducers of cytochrome p450 3a4 (rifampicin or phenytoin) on Atorvastatin is unknown. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin. No interaction was found with cimetidine.

OVERDOSAGE:

There is no specific treatment for atorvastatin overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required liver function tests and serum CPK levels should be monitored. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

PACKAGING:

Atostin 10 Tablet: Each box contains 3x10 tablets in alu-alu blister pack.

Atostin 20 Tablet: Each box contains 1x10 tablets in alu-alu blister pack.

 

 

 

 

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