Medicinal Products

ATORVASTATIN MYLAN PHARMA 80 mg

Generic drug of Tahor
Therapeutic class: Cardiology and angiology
active ingredients: Atorvastatin
laboratory: Mylan

Coated tablet
Box of 30
All forms

Indication

hypercholesterolemia

ATORVASTATIN MYLAN PHARMA is indicated as an adjunct to a diet that is effective in reducing high levels of total (C-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglyceride levels in adults, adolescents, and adults. children aged 10 years or older with primary hypercholesterolemia, including heterozygous familial hypercholesterolaemia or mixed hyperlipidemias (corresponding to Fredrickson Type IIa and IIb), when response to diet and other non-pharmacological measures is inadequate.

ATORVASTATIN MYLAN PHARMA is also indicated for the reduction of total-C and LDL-C levels in adults with homozygous familial hypercholesterolemia in addition to other lipid-lowering drugs (including LDL apheresis) or when such treatments are not available.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in adult patients at high risk of occurrence of first cardiovascular event (see section 5.1 ), in addition to the correction of other risk factors.

Dosage ATORVASTATIN MYLAN PHARMA 80 mg Film-coated tablet Box of 30

Dosage

Before starting treatment with ATORVASTATIN MYLAN PHARMA, the patient should follow a standard cholesterol-lowering diet. This regimen will then be continued for the duration of treatment with ATORVASTATIN MYLAN PHARMA.

The dosage should be adjusted individually based on the initial LDL-C levels, the therapeutic goal and the patient's response to treatment.

The usual starting dose is 10 mg once a day. Dosage adjustment should be performed within a minimum interval of 4 weeks. The maximum dosage is 80 mg once a day.

Primary hypercholesterolemia and combined (mixed) hyperlipidemia

Atorvastatin 10 mg once is sufficient in most patients. A therapeutic effect is observed after two weeks of treatment, the maximum effect being reached after 4 weeks of treatment. The effect is maintained in case of prolonged treatment.

Heterozygous familial hypercholesterolemia

Treatment with ATORVASTATIN MYLAN PHARMA should start at a dose of 10 mg daily. The dose will then be individually adjusted every four weeks to 40 mg daily. Thereafter, the dosage may be increased up to 80 mg per day maximum. A bile acid chelator may also be prescribed in combination with atorvastatin 40 mg daily.

Homozygous familial hypercholesterolemia

Available data are limited. (see section Pharmacodynamic properties ).

In patients with homozygous familial hypercholesterolemia, the dose of atorvastatin ranges from 10 to 80 mg per day (see section 5.1 ). In these patients, atorvastatin should be administered in addition to other lipid-lowering drugs (including LDL-cholesterol apheresis) or when such treatments are not available.

Prevention of cardiovascular diseases

In primary prevention studies, the dosage used was 10 mg / day. A higher dosage may be required to achieve the LDL-C (LDL) target targets set by current guidelines.

Renal failure

No dose adjustment is required (see Warnings and Precautions ).

Hepatic insufficiency

ATORVASTATIN MYLAN PHARMA should be used with caution in patients with hepatic impairment (see sections Warnings and Precautions and Pharmacokinetic Properties ). ATORVASTATIN MYLAN PHARMA is contraindicated in patients with active liver disease (see section 4.3 ).

Use in the elderly

In patients over the age of 70 treated at the recommended doses, the efficacy and safety of use are similar to those seen in the general population.

Pediatric population

hypercholesterolemia

Pediatric use should only be performed by physicians experienced in the treatment of pediatric hyperlipidemia and patients should be monitored regularly to assess progress.

For patients aged 10 years or older, the recommended starting dose of atorvastatin is 10 mg daily, and may be increased up to 20 mg daily. This dose increase should be based on the response and tolerance of pediatric patients to treatment.

The safety data of pediatric patients treated with a dose greater than 20 mg, ie approximately 0.5 mg / kg, are limited.

The experience is limited in children aged 6 to 10 years (see section 5.1 ). Atorvastatin is not indicated for the treatment of patients under 10 years of age.

Other dosage forms / dosages may be more appropriate for this population.

Administration mode

ATORVASTATIN MYLAN PHARMA is for the oral route. Atorvastatin will be taken as a single daily dose regardless of the time of day, during or after meals.

Against indications

ATORVASTATIN MYLAN PHARMA is contraindicated in patients:

· Hypersensitive to the active substance or to any of the excipients of this medicinal product.

· Have active liver disease or persistent and unexplained elevations of serum transaminases greater than three times the upper limit of normal.

· In pregnant, lactating or childbearing women who are not using reliable contraceptive methods (see section Pregnancy and breastfeeding ).

Adverse effects Atorvastatin Mylan Pharma

Controlled clinical studies comparing the effect of atorvastatin to placebo in 16, 066 patients (8755 atorvastatin-treated patients, 7311 placebo-treated patients) treated for an average of 53 weeks, and 5.2% of atorvastatin-treated patients discontinued treatment due to adverse events, compared to 4.0% of patients receiving placebo.

The following adverse reactions observed with atorvastatin are from clinical studies and significant experience gained since product marketing.

The estimated frequencies of adverse reactions are classified according to the following convention: frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (≤ 1/10000).

Infections and infestations

Frequent: nasopharyngitis.

Blood and lymphatic system disorders

Rare: thrombocytopenia.

Immune system disorders

Common: allergic reactions

Very rare: anaphylaxis.

Metabolism and nutrition disorders

Frequent: hyperglycemia.

Uncommon: hypoglycemia, weight gain, anorexia.

Psychiatric disorders

Uncommon: nightmares, insomnia.

Nervous system disorders

Frequent: headache.

Uncommon: dizziness, paresthesia, hypoesthesia, dysgeusia, amnesia.

Rare: peripheral neuropathy.

Eye disorders

Uncommon: blurred vision.

Rare: visual disturbances.

Affections of the ear and labyrinth

Uncommon: tinnitus.

Very rare: hearing loss.

Respiratory, thoracic and mediastinal disorders

Common: pharyngolaryngeal pain, epistaxis.

Gastrointestinal disorders

Common: constipation, flatulence, dyspepsia, nausea, diarrhea

Uncommon: vomiting, upper and lower abdominal pain, belching, pancreatitis.

Hepatobiliary disorders

Uncommon: Hepatitis

Rare: cholestasis.

Very rare: liver failure.

Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, pruritus, alopecia.

Rare: angioneurotic edema, bullous dermatosis including erythema multiforme, Stevens-Johnson syndrome and Lyell syndrome.

Musculoskeletal and connective tissue disorders

Common: myalgia, arthralgia, extremity pain, muscle spasm, joint swelling, back pain.

Uncommon: cervical pain, muscle fatigue.

Rare: myopathy, myositis, rhabdomyolysis, tendinopathy, sometimes complicated by rupture.

Disorders of reproductive organs and breast

Very rare: gynecomastia.

General disorders and administration site conditions

Uncommon: malaise, asthenia, chest pain, peripheral edema, fatigue, pyrexia.

investigations

Frequent: abnormal liver function tests, increased blood levels of creatine phosphokinase.

Uncommon: leukocyturia.

As with other HMG-CoA reductase inhibitors, increases in serum transaminase levels have been reported in patients receiving atorvastatin. These changes were usually mild and transient and did not necessitate discontinuation of treatment. Clinically significant increases (> 3 times the ULN) of serum transaminase levels were observed in 0.8% of patients treated with atorvastatin. These increases were dose-dependent and reversible in all patients.

An increase in serum CPK of more than three times the ULN was observed in 2.5% of patients receiving atorvastatin, a proportion similar to that seen with other HMG-CoA reductase inhibitors in clinical studies . Serum levels greater than ten times the ULN were found in 0.4% of patients treated with atorvastatin (see Warnings and Precautions ).

The following adverse events have been reported with some statins:

· Sexual disorders.

· Depression.

· Exceptional cases of interstitial lung disease, especially during long-term treatment (see Warnings and Precautions section ).

Nervous system disorders

Frequent: headache.

Gastrointestinal disorders

Common: abdominal pain

investigations

Common: Increased alanine aminotransferase, increased blood creatine phosphokinase.

On the basis of available data, the frequency, type and severity of adverse reactions in children are expected to be identical to those in adults. Experience with long-term safety in the pediatric population is currently limited.

Pediatric population

The clinical pharmacovigilance database includes safety data for 249 pediatric patients who received atorvastatin, of which 7 patients were under 6 years of age, 14 patients were in the 6 to 9 year age group, and 228 patients were in an age range of 10 to 17 years.

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