Lipvar 20

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Lipid-lowering agent - Statin group
Barcode: 8936007614259
Description

ATORLIP 20

Keep out of reach of children.

Read the directions carefully before use.

For prescription only.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Active ingredient:

Atorvastatin (as atorvastatin calcium) 20 mg.

Excipients: Lactose monohydrate, avicel, calcium carbonate, hydroxypropyl cellulose, croscarmellose sodium, polysorbat 80, magnesium stearate.

PHARMACEUTICAL FORM: Tablet.

PRODUCT DESCRIPTION:

A white to off-white tablet, oval tablet, plain on both sides, intact edges.

THERAPEUTIC INDICATIONS:

Atorvastatin is  indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B, and triglycerides (TG) and to increase high density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia (heterozygous familar and non-familiar hypercholesterolemia), combined (mixed) hyperlipidaemia (Fredrickson Types IIa and IIb), elevated serum TG levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequetly to diet.

Atorvastatin is also indicated for the reduction of total-C and LDL-C in patients with homozygous familiar hypercholesterolemia.

Prevention of cardiovascular complication

In patients without clinically evident cardiovascular disease (CVD), and with or without dyslipidemia, but with multiple risk factors for coronary heart disease (CHD) such as smoking, hypertension, diabetes, low HDL-C, or a family history of early CHD, atorvastatin is indicated to:

- Reduce the risk of fatal CHD and myocardial infarction (MI)

- Reduce the risk of stroke

- Reduce the risk of revascularization procedures and angina pectoris

In patients with clinically evident CHD, atorvastatin is indicated to:

- Reduce the risk of MI

- Reduce the risk of stroke

- Reduce the risk for revascularization procedures

- Reduce the risk of hospitalization for congestive heart failure (CHF)

- Reduce the risk of angina

Pediatric patients (10-17 years of age)

Atorvastatin is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if, after an adequate trial of diet therapy, the following findings are present:

- LDL-C remains ³ 190 mg/dL or

- LDL-C remains ³ 160 mg/dL and

+ There is a positive family history of premature CVD or

+ Two or more other CVD risk factors are present in the pediatric patient

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 10 mg atorvastatin 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.

Homozygous Familial Hypercholesterolemia

Only limited data are available (see section Pharmacodynamic properties)

The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 mg to 80 mg daily. Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.e., LDL apheresis) in these patients or if such treatments are unavalible.

Prevention of cardiovascular disease

In the primary prevention trials the dose was 10 mg/day. Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines.

Paediatric population with hypercholesterolaemia

Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress.

For patients with Heterozygous Familial Hypercholesterolemia aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day (see section Pharmacodynamic properties). The dose may be increased to 80 mg daily, according to the response and tolerability.

Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more. The dose titration to 80 mg daily is supported by study data in adults and by limited clinical data from studies in children with Heterozygous Familial Hypercholesterolemia (see sections Undesirable effects and Pharmacodynamic properties).

There are limited safety and efficacy data available in children with Heterozygous Familial Hypercholesterolemia between 6 to 10 years of age derived from open-label studies. Atorvastatin is not indicated in the treatment of patients below the age of 10 years. Currently available data are described in sections Undesirable effects, Pharmacodynamic properties and Pharmacokinetic properties but no recommendation on a posology can be made.

Other pharmaceutical forms/strengths may be more appropriate for this population.

Use in Patients with Hepatic Insufficiency

Atorvastatin should be used with caution in patients with hepatic impairment (see sections Special warnings and precaution for use and Pharmacokinetic properties: Special population). Atorvastatin is contraindicated in patients with active liver disease (see section Contraindications).

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 (see section Special warnings and precaution for use).

Use in the Elderly

Efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population (see section Pharmacokinetic properties: Special population).

Use in combination with other medicinal compounds

In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin should be avoided.

In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin and the lowest dose necessary employed.

In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed.

In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed (see sections Special warnings and precautions for use and Interactions)

or as directed by the physician.

CONTRAINDICATIONS:

Hypersensitivity to any component of this medication.

Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN) or who are: Pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

Hepatic Effects

As with other lipid-lowering agents of the same class, moderate (>3 x upper limit of normal [ULN]) elevations of serum transaminases have been reported following therapy with atorvastatin. Liver function was monitored during pre-marketing as well as post-marketing clinical studies of atorvastatin given at doses of 10, 20, 40 and 80 mg.

Persistent increase in serum transaminases (>3 x ULN on two or more occasions) occurred in 0.7% of patients of who received atorvastation in these clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for the 10 mg, 20 mg, 40 mg, and 80 mg doses, respectively. Increases were generally not associated with jaundice or other clinical signs or symptoms. When the dosage of atorvastatin was reduced, or drug treatment interrupted or discontinued, transaminase levels returned to pre-treatment levels. Most patients continued treatment on a reduced dose of atorvastatin without sequelae.

Liver enzyme tests should be performed before initiated with statin and as required by clinic condition. Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve(s). Should an increase in ALT or AST of >3 x ULN persist, reduction of dose or withdrawal of atorvastatin is recommended. Atorvastatin can cause an elevation in transaminases (see section Undesirable effects)

Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of atorvastatin (see section Contraindications)

Skeletal Muscle Effects

Myalgia has been reported in atorvastatin-treated patients (see section Undesirable effects). Creatine phosphokinase (CPK) should be performed before treatment in such cases as: kidney dysfunction, hypothyroidism, personal or family history of hereditary myopathy, history of myopathy acquired due to prior statin and fibrate use, history of liver disease and/or alcohol abuse, elderly patients (over 70 years old) at risk of rhabdomyolysis. If CPK result is 5 times higher than the normal level, treatment with statin should not be initiated. Myopathy, defined as muscle ache or muscle weakness in conjunction with increases in CPK values >10 x ULN, should be considered in any patient with diffuse myalgia, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be avoided to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Atorvastatin therapy should be discontinued of markedly elevated CPK levels occur or if myopathy is diagnosed or suspected. The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, niacin, or azole antifungals, colchicine, telaprevir, boceprevir, or the combination of tipranavir/ritonavir. Many of these drugs inhibit cytochrome P450 3A4 metabolism and/or drug-transport. CYP 3A4 is the primary hepatic isozymes known to be involved in the biotransformation of atorvastatin.

Physicians considering combined therapy with atorvastatin and fibric acid derivatives, gemfibrozil, erythromycin, immunosuppressive drugs, azole antifungals, or lipid-modifying doses of niacin at high level (>1g/day), colchicine should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Therefore, lower starting and maintenance doses of atorvastatin should also be considered when taken concomitantly with the aforementioned drugs. The concurrent use of atorvastatin fusidic acid is not recommended, therefore, temporary suspension of atorvastation is advised during fusidic acid therapy (see section Interactions). Periodic CPK determinations may be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy. Atorvastatin may cause an elevation of CPK (see section Undesirable effects).

As with other drugs in this class, rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria, have been reported. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects. Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis, (e.g., severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).

Hemorrhagic Stroke

In a post-hoc analysis of a clinical study in 4731 patients without CHD who had a stroke or transient ischemic attack (TIA) within the preceding 6 months and were initiated on atorvastatin 80 mg revealed a higher incidence of haemorrhagic stroke in the atorvastatin 80 mg group compared to placebo (55 atorvastatin vs. 33 placebo). Patients with haemorrhagic stroke on entry appeared to be at increased risk of recurrent haemorrhagic stroke (7 atorvastatin vs. 2 placebo). However, in patients treated with atorvastatin 80 mg, there were fewer stroke of any type (265 vs. 311) and fewer CHD events (123 vs. 204) (see section Pharmacodynamic properties and Pharmacokinetic properties)

Endocrine Function

Increase in hemoglobin A1c (HbA1c) and fasting serum glucose levels have been reported with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, including atorvastatin. The risk of hyperglycemia, however, is outweighed by the reduction in vascular risk with statin.

The use of statin drugs for patients with risk factors leading muscle damage should be considered. Statin drugs pose the risks to cause adverse reactions on musculature, such as muscular atrophy, myositis, especially on patients with risk factors, such as over 65 years of age, patients with uncontrolled hypothyroidism, and patients with renal disease. Adverse reactions should be monitored closely during administration.

Before treatment, creatine kinase (CK) test should be performed in case of potential drug interactions and for some special patients. In these cases, benefits/risks should be considered and patients should be monitored clinically with statins. During treatment with statin, patients should inform their doctors if muscle signs are noticed, such as muscle pain, muscle stiffness, muscle weakness, etc. When those signs appear, CK test should be performed to take appropriate interventions.

Concomitant treatment with other medicinal products

Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins (e.g. ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, letermovir and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc). The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, antivirals for the treatment of hepatitis C (HCV) (boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin or ezetimibe. If possible, alternative (non-interacting) therapies should be considered instead of these medicinal products.

In cases where co-administration of these medicinal products with atorvastatin is necessary, the benefit and the risk of concurrent treatment should be carefully considered. When patients are receiving medicinal products that increase the plasma concentration of atorvastatin, a lower maximum dose of atorvastatin is recommended. In addition, in the case of potent CYP3A4 inhibitors, a lower starting dose of atorvastatin should be considered and appropriate clinical monitoring of these patients is recommended (see section Interactions).  

Atorvastatin must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination (see section Interactions). The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.

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