Stacor 10mg

Tablet
Atorvastatin Calcium
Unimed Unihealth MFG. Ltd

Other Strength:
- Stacor 20mg
- Stacor 40mg

Alternative:
- Tiginor 10mg
- Anzitor 10mg
- Xelpid 10mg
- Locol 10mg
- Atasin 10mg
- Lipistat 10mg
- Atovin 10mg
- TCL-R 10mg
- Zuvas 10mg
- Vastor 10mg
- Liptor 10mg



Stacor
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.

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