Medicinal Products

ATORVASTATIN RATIO 20 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 lowering elevated levels of total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides in patients with heterozygous or mixed primary familial hypercholesterolaemia, hyperlipidemia ( type IIA, IIb according to the Fredrickson classification), when the response to diet alone or to other non-pharmacological measures is inadequate.

Atorvastatin is also indicated for lowering LDL and total cholesterol levels in patients with homozygous familial hypercholesterolemia, in combination or not with other treatments.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in patients considered to be at high risk of occurrence of a first cardiovascular event (see section on Pharmacodynamic properties ), in combination with corrective treatments for other risk factors.

Dosage ATORVASTATIN RATIO 20 mg Film-coated tablet Box of 90

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 adjusted according to the initial levels of LDL cholesterol, the objective and the response to the treatment of each patient.

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

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

Primary hypercholesterolemia and combined (mixed) hyperlipidemia

A single dose of atorvastatin 10 mg is sufficient in the majority of 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. The dosage can be increased up to 80 mg per day. A bile acid chelator may also be prescribed in combination with atorvastatin 40 mg daily.

Homozygous familial hypercholesterolemia

In a compassionate use study in 64 patients, data on LDL cholesterol receptors were measured in 46 patients. In these 46 patients receiving up to 80 mg of atorvastatin daily, the mean decrease in LDL-cholesterol was 21%.

In patients with homozygous familial hypercholesterolemia, the dose of atorvastatin is 10 to 80 mg daily. In these patients, atorvastatin should be used in combination or not with other lipid-lowering drugs such as LDL cholesterol apheresis (in case of unavailability of this type of treatment).

Prevention of cardiovascular diseases

In primary prevention studies, a dosage of 10 mg per day was used. Higher dosages may be required to achieve the LDL cholesterol goals set by current guidelines.

Dosage in patients with renal insufficiency

Renal function abnormalities have no influence on the plasma concentrations of atorvastatin. It is the same for the effects of lipids on atorvastatin. As a result, no dosage adjustment is necessary.

Use in elderly patients

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

children

Pediatric use should be reserved for specialists.

Experience in children is limited to a small number of patients (aged 4-17 years) with severe dyslipidemia, such as homozygous familial hypercholesterolemia. The recommended initial dose in this population is atorvastatin 10 mg daily. Depending on the patient's response and tolerance to the treatment, the dosage may be increased to 80 mg per day. The impact of treatment on development (safety data) has not been studied in this population.

Against indications

Atorvastatin is contraindicated in patients with the following characteristics:

· Hypersensitivity to the active substance or to any of the excipients,

· Progressive liver disease or unexplained persistent elevations of serum transaminases greater than 3 times the upper limit of normal (ULN),

· Myopathy,

· Pregnant, breastfeeding or childbearing women who do not take reliable contraceptive measures (see section Pregnancy and breastfeeding ).

Atorvastatin Ratio

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 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.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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