Medicinal Products

ATORVASTATIN KRKA 80 mg

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

Coated tablet
Box of 30
All forms

Indication

hypercholesterolemia

ATORVASTATIN KRKA is indicated as an adjunct to a diet that is suitable for lowering high levels of total cholesterol, LDL-cholesterol (LDL-C), apolipoprotein B and triglycerides in adults, adolescents, and children 10 years of age or older. more with heterozygous familial primary hypercholesterolemia or combined (mixed) hyperlipidemia (Fredrickson type IIa, IIb), when the response to diet alone or to other non-pharmacological measures is insufficient.

ATORVASTATIN KRKA is also indicated for the reduction of LDL-C and total cholesterol levels in adults with homozygous familial hypercholesterolemia, in combination with other lipid-lowering drugs (such as LDL-C apheresis) or in the case of unavailability of this type of treatment.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in adult patients considered to be at high risk of occurrence of a first cardiovascular event (see section 5.1 Pharmacodynamic properties ), in combination with corrective treatments for other risk factors.

Dosage ATORVASTATIN KRKA 80 mg Film-coated tablet Box of 30

Dosage

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

The dosage should be adjusted individually based on the initial LDL cholesterol 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

A single dose of ATORVASTATIN KRKA 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 chronic treatment.

Heterozygous familial hypercholesterolemia

Treatment will be started with a daily dose of 10 mg ATORVASTATIN KRKA. 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 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 is between 10 and 80 mg per day maximum (see section 5.1 Pharmacodynamic properties ). In these patients, atorvastatin should be used in combination with other lipid-lowering drugs (including LDL cholesterol apheresis) or when such treatment is not available.

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.

Renal insufficiency

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

Hepatic insufficiency

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

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 be reserved for specialists and patients should be re-evaluated on a regular basis to assess progress.

For children aged 10 years and older, the recommended starting dose of atorvastatin is 10 mg daily and can be increased up to 20 mg daily. This increase should be based on the child's response and tolerance. Safety information for children treated with doses greater than 20 mg, corresponding to approximately 0.5 mg / kg, is limited.

Experience in children aged 6 to 10 years is limited (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 KRKA is intended 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 is contraindicated in patients with:

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),

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

Atorvastatin Krka side effects

Controlled clinical studies comparing the effect of atorvastatin with placebo in 16, 066 patients (8, 755 atorvastatin-treated patients, 7, 311 patients treated with placebo) treated for an average of 53 weeks, 5.2% of patients atorvastatin were discontinued 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.

Hematological 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 the reproductive organs and the breast:

Very rare: gynecomastia.

General disorders and administration site defects:

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 KRKA. These changes were usually mild and transient and did not necessitate discontinuation of treatment. Clinically significant increases (> 3 times the upper limit of normal) in serum transaminase levels were observed in 0.8% of patients treated with ATORVASTATIN KRKA. These increases were dose-dependent and reversible in all patients.

An increase in serum creatine phosphokinase (CPK) by more than three times the upper limit of normal was observed in 2.5% of patients receiving ATORVASTATIN KRKA, a proportion similar to that seen with other HMG inhibitors -CoA reductase in clinical studies. Serum levels greater than ten times the upper limit of normal were observed in 0.4% of patients treated with ATORVASTATIN KRKA (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 ).

· 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.

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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