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Atorvastation

Atorvastation Winthrop Tablet

 

Atorvastatin 10mg film-coated tablets

Atorvastatin 20 mg film-coated tablets

Atorvastatin 40 mg film-coated tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION

Atorvastatin 10 mg film-coated tablets:
1 film-coated tablet contains 10.34 mg of atorvastatin calcium, which equals to 10 mg of atorvastatin;
Atorvastatin 20 mg film-coated tablets:
1 film-coated tablet contains 20.68 mg of atorvastatin calcium, which equals to 20 mg of atorvastatin
Atorvastatin 40 mg film-coated tablets:
1 film-coated tablet contains 41.36 mg of atorvastatin calcium, which equals to 40 mg of atorvastatin.


PHARMACEUTICAL FORM
Film-coated tablets
White to off-white, oval-shaped biconvex film-coated tablets


CLINICAL PARTICULARS
Therapeutic indications
Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated serum triglyceride levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Atorvastatin is also indicated for the reduction of total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolemia when response to diet and other non-pharmacological measures are inadequate.

Prevention of Cardiovascular Disease
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, Atorvastatin is indicated to:
-Reduce the risk of myocardial infarction
-Reduce the risk of stroke
-Reduce the risk for revascularization procedures and angina

In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, Atorvastatin is indicated to:
-Reduce the risk of myocardial infarction
-Reduce the risk of stroke

Posology and method of administration
General - 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 underlying medical problems. The patient should continue on a standard cholesterol lowering diet during treatment with atorvastatin. The dosage range is 10 to 80 mg once daily. Doses may be given any time of the day, with or without food. Starting and maintenance dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response. After initiation and/or upon titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks, and dosage adjusted accordingly.

Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia

- The majority of patients are controlled with 10mg atorvastatin once a day. A therapeutic response is evident within two weeks, and the maximum response is usually achieved within four weeks. The response is maintained during chronic therapy.

Heterozygous Familial Hypercholesterolaemia

Adults:
Patients should be started with Atorvastatin 10 mg daily. Doses should be individualised and adjusted every 4 weeks to 40 mg daily. Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant (eg, colestipol) may be combined with 40 mg Atorvastatin.


Children aged 10-17 years :
Doses above 20mg/day and combination therapies have not been investigated.

Use in Patients with Renal Insufficiency
- Renal disease has no influence on the plasma concentrations or on the LDL-C reduction with atorvastatin. Thus, no adjustment of the dose is required.

Use in the Elderly
- No differences in safety, efficacy or lipid treatment goal attainment were observed between elderly patients and the overall population


Use in Children
- Treatment experience in a pediatric population is limited.

 

Contraindications
Atorvastatin is contraindicated in the event of
- hypersensitivity to any of the ingredients of the medicinal product
- active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the normal value
- myopathy

- pregnancy

- lactation


Special warnings and precautions for use
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 than 3 times the upper limit of normal persist, 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 have a history of liver disease.

Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)
In a post-hoc analysis of stroke subtypes in patients without CHD who had a recent stroke or TIA there was a higher incidence of haemorrhagic stroke in patients initiated on atorvastatin 80 mg compared to placebo. The increased risk was particularly noted in patients with prior haemorrhagic stroke or lacunar infarct at study entry. For patients with prior heemorrhegic stroke or lacunar infarct, the balance of risks and benefits of atorvastatin 80 mg is uncertain and the potential risk of haemorrhagic stroke should be carefully considered before initiating treatment.

Muscle effects
Treatment with HMG-CoA reductase inhibitors (statins) has been associated with the onset of myalgia, myopathy, and very rarely rhabdomyolysis. Myopathy must be considered in any patient under statin therapy presenting with unexplained muscle symptoms such as pain or tenderness, muscle weakness or muscle cramps. In such cases creatine kinase (CK) levels should be measured (see below).

Creation phosphokinase measurement
Creatine phosphokinase (CPK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CPK increase as this makes value interpretation difficult. If CPK levels are significantly elevated at baseline ( >5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results.

Before treatment
As with other statins atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. A creatine phosphokinase (CPK) level should be measured before starting treatment in the following situations:
- Renal impairment

- Hypothyroidism
- Personal or familial history of hereditary muscular disorders

- Previous history of muscular toxicity with a statin or fibrate
- Previous history of liver disease and/or where substantial quantities of alcohol are consumed
- In elderly (age > 70 years), the necessity of such measurement should be considered, according to the presence of other predisposing factors for rhabdomyolysis


In such situations, the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended. If CPK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started.
 

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