Generic drug of Tahor
Therapeutic class: Cardiology and angiology
active ingredients: Atorvastatin
laboratory: Pfizer Holding France
Box of 90
ATORVASTATIN is indicated in combination with a diet to reduce elevated levels of total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in adults, adolescents, and children 10 years of age and older with primary hypercholesterolemia, including Familial hypercholesterolemia (heterozygote) or mixed hyperlipidemias (corresponding to Fredrickson's Type IIa and IIb), when response to a diet or other non-pharmacological treatments is not sufficient.
ATORVASTATIN is also indicated to reduce the levels of Chol-T and LDL-C in adults with homozygous familial hypercholesterolemia in addition to other lipid-lowering treatments (including LDL apheresis) or if such treatments are unavailable.
Prevention of cardiovascular diseases
Prevention of cardiovascular events in adult patients at high risk of having a first cardiovascular event, in addition to the correction of other risk factors.
Dosage ATORVASTATINE PFIZER 40 mg Film-coated tablet Box of 90
Before starting treatment with ATORVASTATINE PFIZER, the patient should follow a standard cholesterol-lowering diet. This regimen will then be continued for the duration of treatment with ATORVASTATIN PFIZER.
The dosage should be adjusted individually based on the initial levels of LDL-cholesterol, the therapeutic goal and the response to the patient's 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 PFIZER 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
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 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-cholesterol (LDL) targets set by current guidelines.
Patients with renal insufficiency
No dose adjustment is required (see Warnings and Precautions ).
Patients with hepatic insufficiency
ATORVASTATIN PFIZER should be used with caution in patients with hepatic impairment (see sections Warnings and Precautions and Pharmacokinetic Properties ). ATORVASTATIN PFIZER 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 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.
ATORVASTATINE PFIZER 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.
ATORVASTATIN PFIZER is contraindicated in patients:
· With hypersensitivity to the active substance or to any of the excipients of this medicinal product mentioned in the Composition section,
· Have active liver disease or persistent and unexplained elevations of serum transaminases greater than three times the upper limit of normal,
· In pregnant, breastfeeding or childbearing women who are not using a reliable method of contraception (see section Pregnancy and breast-feeding ).
Atorvastatin Pfizer side effects
In controlled clinical studies comparing the effect of atorvastatin with placebo in 16066 patients (8755 atorvastatin-treated patients, 7311 placebo-treated patients) treated for an average of 53 weeks, 5.2% of patients treated with 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 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), not known (can not be estimated based on available data).
Infections and infestations
Blood and lymphatic system disorders
Immune system disorders
Common: allergic reactions
Very rare: anaphylaxis.
Metabolism and nutrition disorders
Uncommon: hypoglycemia, weight gain, anorexia.
Uncommon: nightmares, insomnia.
Nervous system disorders
Uncommon: dizziness, paresthesia, hypoesthesia, dysgeusia, amnesia.
Rare: peripheral neuropathy.
Uncommon: blurred vision.
Rare: visual disturbances.
Affections of the ear and labyrinth
Very rare: hearing loss.
Respiratory, thoracic and mediastinal disorders
Common: pharyngolaryngeal pain, epistaxis.
Common: constipation, flatulence, dyspepsia, nausea, diarrhea
Uncommon: vomiting, upper and lower abdominal pain, belching, pancreatitis.
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.
Not known: necrotizing myopathy with immune mediation.
Disorders of reproductive organs and breast
Very rare: gynecomastia.
General disorders and administration site conditions
Uncommon: malaise, asthenia, chest pain, peripheral edema, fatigue, pyrexia.
Frequent: abnormal liver function tests, increased blood levels of creatine phosphokinase.
As with other HMG-CoA reductase inhibitors, increases in serum transaminase levels have been reported in patients receiving ATORVASTATIN PFIZER. 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 PFIZER. 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 PFIZER, 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 PFIZER (see Warnings and Precautions ).
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
Common: Abdominal pain
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.
The following adverse events have been reported with some statins:
· Sexual disorders,
· Exceptional cases of interstitial lung disease, particularly during long-term treatment (see Warnings and precautions for use section ),
· Diabetes: The frequency depends on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol / l, BMI> 30 kg / m², increased triglyceride levels, history of hypertension).
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.