Stacor Tablet 10mg

Product Information

STACOR

Stacor®(Atorvastatin)

Presentation

Stacor-10 tablet: Grey, shield shaped, film coated tablet; each tablet contains Atorvastatin Calcium Trihydrate equivalent to

Atorvastatin USP 10 mg.

Stacor-20 tablet: Grey, barrel shaped, film coated tablet; each tablet contains Atorvastatin Calcium Trihydrate equivalent to

Atorvastatin USP 20 mg.

Stacor-40 tablet: Grey, oblong shaped, scored, having engraved on other side, film coated tablet; each tablet contains

Atorvastatin Calcium Trihydrate equivalent to Atorvastatin USP 40 mg.

Indication

Stacor is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDLcholesterol, apolipo-protein B, and

triglycerides in patients with primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined (mixed)

hyperlipidaemia when response to diet and other nonpharmacological measures is inadequate. Stacor is also indicated as an adjunct

to diet and other non-dietary measures in reducing elevated total cholesterol, LDL-cholesterol, and apolipo-protein B in patients

with homozygous familial hypercholesterolaemia when response to these measures is inadequate.

Dosage and administration

The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this

diet during treatment with atorvastatin. The usual starting dose is 10mg (one Stacor-10 tablet) once a day. Doses should be

individualised according to baseline LDL-C levels, the goal of therapy, and patients response. Adjustment of dosage should be made

at intervals of 4 weeks or more, the maximum dose is 80mg (two Stacor-40 tablets) once a day. Doses may be given at any time of

day with or without food. Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia: The majority of patients are

controlled with 10mg atorvastatin (one Stacor-10 tablet) once a day. A therapeutic response is evident within 2 weeks, and the

maximum response is usually achieved within 4 weeks. The response is maintained during chronic therapy. Heterozygous familial

hypercholesterolaemia: Patients should be started with atorvastatin 10mg (one Stacor-10 tablet) daily. Doses should be

individualised and adjusted every 4 weeks to 40mg (one Stacor-40 tablet) daily. Thereafter, either the dose may be increased to a

maximum of 80mg (two Stacor-40 tablets) daily or a bile acid sequestrant (eg, colestipol) may be combined with 40mg atorvastatin

(one Stacor-40 tablet). Homozygous familial hypercholesterolaemia: Adults: In a compassionate use study of patiens with homozygous

familial hypercholesterolaemia, most patient responded to a dose of 80mg of atorvastatin (two Stacor-40 tablets).

Children: Treatment experience in a paediatric population with doses of atorvastatin upto 80mg/day is limited.

Dosage in patients with renal insufficiency: Renal disease has no influence on the plasma concentrations nor lipid effects of

atorvastatin, thus no adjustment of dose is required. Dosage in patients with hepatic dysfunction: Caution should be excercised in

patients who have a history of liver disease.

Geriatric use: Adequate treatment experience in adults age 70 or older with doses of Atorvastatin up to 80mg (two Stacor-40

tablets)/day has been obtained. Efficacy and safety in older patients using recommended doses is similar to that seen in the

general population.

Contra-indications, warnings, etc.

Contra-indications: Atorvastatin is contra-indicated in patients with hypersensitivity to atorvastatin, active liver disease or

unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal, during pregnancy,

while breast-feeding, and in women of child bearing potential not using appropriate contraceptive measures.

Precautions: Liver effects: Liver function tests should be performed before the initiation of treatment and periodically

thereafter. Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed.

Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve. Should an increase in

ALT or AST of greater that 3 times the upper limit of normal presist, reduction of dose or withdrawal of atorvastatin is

recommended. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or who have a

history of liver disease.

Skeletal muscle effects: Uncomplicated myalgia has been reported in atorvastatin-treated patients. Atorvastatin therapy should be

discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Patients who develop any signs

or symptoms suggestive of myopathy should have CPK levels measured. Should significant increase in CPK persist, reduction of dose

or withdrawal of atorvastatin in recommended. These CPK elevations should be considered when evaluating the possibility

of myocardial infarction in the differential diagnosis of chest pain. Rhabdomyolysis with renal dysfunction secondary to

myoglobinuria has been reported with other drugs in this class.

Drug interactions: 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. This increase in risk may also

occur when combining these drugs with atorvastatin. More specific in vitro studies using human hepatic microsomes and cells

expressing human cytochrome P450 isozymes show that atorvastatin, like other HMG-CoA reductase inhibitors, is metabolised by

cytochrome P450 3A4 indicating the possibility of an interaction with drugs also metabolised by this isozyme. When combining

atorvastatin with other drugs which are the substrate of this isozyme (eg, immunomodulators, many antiarrhythmic agents, some

calcium channelantagonists and some benzodiazepines) the possibility of a change in the plasma drug levels of either drug should

be considered. In clinical studies in which atorvastatin was administered with antihypertensives (including ACE inhibitors,

beta-blockers, calcium channel antagonists, and diuretics) or hypoglycaemic agents no clinically significant interactions were

seen. Based on experience with other HMG-CoA reductase inhibitors caution should also be exercised when atorvastatin is

administered with inhibitors of cytochrome P450 3A4 (eg, macrolide antibiotics and azole antifungals). The effect of inducers of

cytochrome P450 3A4 (eg, rifampicin or phenytoin) on atorvastatin is unknown.

Digoxin: Administration of multiple doses of atorvastatin with digoxin increased steady-state plasma digoxin concentrations by

approximately 20%. Patients taking digoxin should be monitored appropriately. Erythromycin: In healthy individuals, administration

of atorvastatin with erythromycin (500mg QID), a known inhibitor of cytochrome P450 3A4, was associated with higher plasma

concentrations of atorvastatin.

Warfarin: Administration of atorvastatin with warfarin caused a minimal decrease in prothrombin time (mean±SE of 1.7±0.4 seconds)

during the first 4 days of dosing with 80mg atorvastatin. Dosing continued for 15 days and prothrombin time returned to normal by

the end of atorvastatin treatment. Nevertheless, patients receiving warfarin should be closely monitored when atorvastatin is

added to their therapy.

Cimetidine: An interaction study with cimetidine and atorvastatin was conducted, and no interaction was seen.

Use in pregnancy and lactation: Atorvastatin is contra-indicated in pregnancy and while breast feeding. Women of childbearing

potential should use appropriate contraceptive measures. An interval of 1 month should be allowed from stopping atorvastatin

treatment to conception in the event of planning a pregnancy.

Effects on ability to drive or use machines: There is no pattern of reported adverse events suggesting that patients taking

atorvastatin will have any impairment of ability to drive and use hazardous machinery.

Adverse effect: Atorvastatin is generally well-tolerated. Adverse reactions have usually been mild and transient. Less than 2% of

patients were discontinued from clinical trials due to side effects attributed to atorvastatin. The most frequent (1% or more)

adverse effects associates with atorvastatin therapy, in patients participating in controlled clinical studies are constipation,

flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, asthenia, diarrhoea, and insomnia.

Overdose: Specific treatment is not available for atorvastatin overdosage. Should an overdose occur, 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, haemodialysis is not expected to significantly enhance atorvastatin

clearance.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Package quantities

Stacor-10 tablet: Carton containing 30 tablets in alu-alu blister.

Stacor-20 tablet: Carton containing 30 tablets in alu-alu blister.

Stacor-40 tablet: Carton containing 10 tablets in alu-alu blister.