Medicinal Products

ATORVASTATIN ZYDUS FRANCE 40 mg

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

Coated tablet
Box of 30
All forms

Indication

hypercholesterolemia

ATORVASTATIN ZYDUS FRANCE is indicated, in addition to a diet, to reduce the levels of total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B and triglycerides in adults, adolescents and adults. children aged 10 years or older with primary hypercholesterolemia, including familial (heterozygous) or mixed hypercholesterolemia (corresponding to Fredrickson's Types IIa and IIb), when the response to diet and other non-pharmacological measures is inadequate.

ATORVASTATIN ZYDUS FRANCE is also indicated to reduce the levels of total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolemia, in addition to other lipid-lowering treatments (including LDL apheresis), or when these treatments are not available.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in patients at high risk of having a first cardiovascular event (see section on Pharmacodynamic properties ), in addition to the correction of other risk factors.

Dosage ATORVASTATINE ZYDUS FRANCE 40 mg Film-coated tablet Box of 30

Dosage

The patient should follow a standard cholesterol-lowering diet before taking ATORVASTATIN ZYDUS FRANCE; this diet should be continued for the duration of the treatment.

The dose will be adjusted individually based on the initial level of LDL-cholesterol, the therapeutic goal and the patient's response to treatment.

The usual starting dose is 10 mg once a day.

Dosage adjustment will be at intervals of at least 4 weeks. The maximum dose is 80 mg once a day.

Primary hypercholesterolemia and mixed hypercholesterolemia

A dose of atorvastatin 10 mg once daily provides satisfactory control in the majority of patients.

The therapeutic response occurs within 2 weeks and is usually maximal after 4 weeks. It is maintained in case of chronic treatment.

Heterozygous familial hypercholesterolemia

The initial dose is 10 mg once a day.

Dosage adjustment will be done individually at 4 week intervals up to a dose of 40 mg daily.

The dosage may then be increased to a maximum of 80 mg per day. A bile acid chelator may also be associated with atorvastatin 40 mg once daily.

Homozygous familial hypercholesterolemia

The available data are limited (see section on Pharmacodynamic properties ).

In patients with homozygous familial hypercholesterolemia, the dose of atorvastatin was 10 to 80 mg daily (see section 5.1 Pharmacodynamic properties ). Atorvastatin will be used in these patients in addition to other lipid-lowering drugs (including LDL apheresis), or when such treatments are not available.

Prevention of cardiovascular diseases

In primary prevention studies, the dose was 10 mg daily.

An increase in dosage may be necessary to achieve the LDL-cholesterol level recommended by current guidelines.

Renal failure

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

Hepatic insufficiency

ATORVASTATIN ZYDUS FRANCE should be used with caution in patients with hepatic impairment (see sections Warnings and Precautions and Pharmacokinetic Properties ).

ATORVASTATIN ZYDUS FRANCE is contraindicated in patients with active liver disease (see section 4.3 ).

Use in the elderly

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

Pediatric use

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

Oral way.

The daily dose of atorvastatin will be given as a single dose at any time of the day, regardless of the meal.

Against indications

ATORVASTATIN ZYDUS FRANCE is contraindicated in patients with:

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

· Progressive liver disease or a persistent and unexplained increase in serum transaminases exceeding 3 times the upper limit of normal.

· In case of pregnancy.

· During breastfeeding.

· In women of childbearing potential not taking adequate contraceptive measures (see section Pregnancy and breastfeeding ).

Adverse effects Atorvastatin Zydus France

In controlled clinical trials comparing the effect of atorvastatin to placebo in 16, 066 patients (8755 atorvastatin-treated patients vs. 7311 placebo-treated patients) 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 are related to the adverse event profile of atorvastatin from clinical studies and the significant experience gained since product marketing.

Estimated frequencies of adverse events are classified as follows: frequent (≥ 1/100, <1/10); infrequent (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (≤ 1/10000).

Infections and infestations

Common: 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: somnolence, paresthesia, hypoesthesia, dysgeusia, amnesia.

Rare: peripheral neuropathy.

Eye disorders

Uncommon: blurred vision.

Rare: visual disturbances.

Hearing and auditory problems

Uncommon: tinnitus.

Very rare: hearing loss.

Respiratory, thoracic and mediastinal disorders

Common: pharyngolaryngeal pain, nosebleeds.

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.

Dermatological and subcutaneous disorders

Uncommon: urticaria, rash, pruritus, alopecia.

Rare: angioneurotic edema, dermatitis herpetiformis including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Musculoskeletal and Connective Tissue Disorders

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

Uncommon: neck pain, muscle fatigue.

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

Reproductive system and breast disorders

Very rare: gynecomastia.

General disorders and administration site

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 HGM-CoA reductase inhibitors, elevated levels of serum transaminases have been reported in patients receiving atorvastatin. These changes were generally mild, 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. These increases were dose-dependent and reversible in all patients.

An increase in serum CPK of more than three times the upper limit of normal was observed in 2.5% of patients receiving atorvastatin, a proportion similar to that seen with other HMG-CoA reductase inhibitors. clinical studies. Serum levels greater than 10 times the upper limit of normal were observed in 0.4% of atorvastatin-treated patients (see Warnings and Precautions section ).

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.

The following side effects have been reported with some statins: sexual dysfunction, depression, exceptional cases of interstitial lung disease, especially during long-term treatment (see Warnings and Precautions section ).

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