Medicinal Products

ATORVASTATIN TEVA HEALTH 80 mg

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

Coated tablet
Box of 90
All forms

Indication

hypercholesterolemia

Atorvastatin is indicated as an adjunct to a diet adapted to reduce high levels of total cholesterol (Chol-T), LDL-cholesterol (LDL-C), apolipoprotein B and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia including heterozygous familial hypercholesterolemia or mixed hyperlipidemia (Fredrickson type IIA, IIb), when response to diet and other non-pharmacological measures is inadequate.

Atorvastatin is also indicated for the reduction of Chol-T and LDL-C levels in adults with homozygous familial hypercholesterolemia, in addition to other lipid-lowering drugs (including LDL-C apheresis) or if such treatments are unavailable.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in adult patients who are at high risk of having a first cardiovascular event (see section 5.1 Pharmacodynamic properties ), in combination with corrective treatments of other risk factors.

Dosage ATORVASTATIN TEVA HEALTH 80 mg Film-coated tablet Box of 90

Dosage

Before starting treatment with atorvastatin, the patient should follow a standard cholesterol-lowering diet; this diet will then be continued for the duration of atorvastatin treatment.

The dosage should be individually adjusted based on the initial LDL-C levels, the objective and the therapeutic response to the treatment of each patient.

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 will be started with a daily dose of atorvastatin 10 mg. The dosage will then be individually adjusted every 4 weeks to 40 mg per day. Thereafter the dose of atorvastatin may be increased up to 80 mg per day. A bile acid chelator may be prescribed in combination with atorvastatin 40 mg daily.

Homozygous familial hypercholesterolemia

The available data are limited (see section on 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 therapies (including LDL-C apheresis) or when such treatments are not available.

Prevention of cardiovascular diseases

In primary prevention studies, the dosage used was 10 mg per day. A higher dosage may be necessary to achieve the LDL-C target objectives set by the current recommendations.

Renal failure

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

Hepatic insufficiency

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

Use in elderly patients

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 / dosage may be more appropriate for this population.

Administration mode

Oral administration. Atorvastatin will be taken in a single daily dose, regardless of the time of day, during or after meals.

Against indications

Atorvastatin 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 3 times the upper limit of normal (ULN).

· In pregnant, lactating or child-bearing women who are not using reliable contraceptive methods (see section Pregnancy and breast-feeding ).

Adverse effects Atorvastatin Teva Sante

In controlled clinical trials comparing the effect of atorvastatin to placebo in 16, 066 patients (8755 atorvastatin-treated versus 7311 placebo-treated patients) treated for an average of 53 weeks, 5.2% of patients treated by atorvastatin 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 post-marketing experience with atorvastatin.

The estimated frequencies of adverse reactions are classified according to the following convention: frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (≤ 1/10 000).

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

Frequent: myalgia, arthralgia, extremity pain, muscle spasm, swelling of the joints, back pain.

Uncommon: neck 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 treated with atorvastatin. These increases were generally mild and transient and did not require treatment interruption. Increases in clinically significant serum transaminases (> 3 times the ULN) were observed in 0.8% of patients treated with atorvastatin. These increases were dose-dependent and reversible in all patients.

An increase in serum creatine phosphokinase (CPK) levels greater than three times the ULN was observed in 2.5% of atorvastatin-treated patients, a proportion similar to that seen with other HMG-CoA inhibitors reductase in clinical trials. Serum levels> 10 x ULN were reported in 0.4% of atorvastatin-treated patients (see Warnings and Precautions section ).

The following side effects have been reported with statins:

· Sexual disorders.

· Depression.

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

· Diabetes: Frequency depends on the presence or absence of risk factors (fasting blood glucose ³ 5.6 mmol / l, BMI> 30 kg / m², increased triglyceride levels, previous high blood pressure).

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.

Nervous system disorders

Frequent: headache.

Gastrointestinal disorders

Common: abdominal pain

investigations

Frequent: increased alanine aminotransferase, increased creatine blood 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.

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