Atorvastatin 10mg film-coated
Atorvastatin 20 mg film-coated
Atorvastatin 40 mg film-coated
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atorvastatin 10 mg film-coated
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.
White to off-white, oval-shaped biconvex film-coated tablets
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
-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
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.
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
Special warnings and precautions for use
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.
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.
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
- 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
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