Medicinal Products

ATORVASTATIN MYLAN 40 mg

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

Coated tablet
Box of 30
All forms

Indication

hypercholesterolemia

atorvastatin Mylan 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 primary hypercholesterolemia including familial hypercholesterolemia (heterozygous) or Combined hyperlipidemia (mixed type IIA, IIb according to Fredrickson's classification), when the response to diet and other non-pharmacological measures is inadequate.

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

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 MYLAN 40 mg Film-coated tablet Box of 30

Oral administration

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

The starting dose is 10 mg once daily. The dosage should be adjusted individually according to the initial LDL cholesterol level, the therapeutic objective and the response to the treatment of each patient.

Dosage adjustment should be within a minimum interval of 4 weeks. The maximum dosage is 80 mg 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 mixed hyperlipidemia

A dose of atorvastatin 10 mg once daily provides satisfactory control in the majority of patients. The therapeutic response is observed in 2 weeks and is usually maximal after 4 weeks. The effect is maintained during 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 may be increased to a maximum of 80 mg / day or a bile acid chelator may be combined with atorvastatin 40 mg once 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 Mylan should be used in combination with other lipid-lowering drugs such as 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 necessary 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 lipid effects of atorvastatin. As a result, no dosage adjustment is necessary.

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.

The experience in children is limited to a small number of subjects (aged 4-17 years) with severe dyslipidemia, such as homozygous familial hypercholesterolemia. The recommended initial dose in this population is atorvastatin 10 mg daily. A limited number of children have been treated with doses up to 80 mg daily. Dosages above 20 mg per day have not been studied in children under 18 years of age. Developmental safety data has not been evaluated in this population.

Against indications

Atorvastatin Mylan 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 greater than 3 times the upper limit of normal (ULN),

· Myopathy,

· If you are pregnant,  during breastfeeding, remove women of childbearing potential who are not taking reliable contraceptive measures (see section Pregnancy and breast-feeding ).

Atorvastatin Mylan side effects

The side effects were most often mild and transient. Less than 2% of patients were excluded from clinical trials because of atorvastatin-related adverse events.

The most common effects (1% or more) associated with atorvastatin therapy and reported in clinical trials were:

Nervous system disorders: headaches

General disorders and administration site conditions: asthenia

Gastrointestinal disorders: abdominal pain, dyspepsia, nausea, flatulence, constipation, diarrhea

Psychiatric conditions: insomnia

Musculoskeletal and systemic disorders: myalgia

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 discontinuation of treatment. Increases in clinically significant serum transaminases (> 3 times the upper limit of normal) were observed in 0.7% of patients treated with atorvastatin. The incidence of these abnormalities was 0.2%, 0.2%, 0.6% and 2.3% for doses of 10, 20, 40 and 80 mg, respectively. These elevations were reversible in all patients.

High serum creatine phosphokinase (CPK) levels greater than 3 times the upper limit of normal were observed in 2.5% of patients treated with atorvastatin. Rates 10 times the limit were reported in 0.4% of patients treated with atorvastatin. Of these patients, 0.1% also had muscle pain, tenderness, or weakness.

Other adverse events that have been reported in clinical trials of atorvastatin are listed below by organ class and frequency.

The table below lists adverse reactions based on clinical trial data and post-marketing experience.

The estimated frequencies of side effects are: very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000).

Class of organ

Very common

(≥ 1/10)

Frequent

(≥ 1/100,

<1/10)

Rare

(≥ 1/1000, <1/100

Rare (≥1 / 10, 000, <1/1000)

Very rare (<1 / 10, 000).

Blood and lymphatic system disorders

very rare

Immune system disorders

allergic reactions

anaphylaxis

Endocrine disorders

alopecia, hyperglycemiahypoglycemia, pancreatitis

Psychiatric disorders

insomnia

amnesia

Nervous system disorders

headache, dizziness paresthesia, hypoesthesia

peripheral neuropathy

dysgeusia (taste disorder)

Eye disorders

visual disturbances

Affections of the ear and labyrinth

visual disturbances

hearing loss.

Gastrointestinal disorders

constipation, flatulence, dyspepsia, nausea, diarrhea

anorexia, vomiting

Hepatobiliary disorders

hepatitis, jaundice by obstruction

Hepatic insufficiency

Skin and subcutaneous tissue disorders

rash, pruritus

urticaria

Quinck edema, bullous skin rash (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrosis)

Musculoskeletal, bone and systemic disorders

myalgia, arthralgia

myopathy

myositis, rhabdomyolysis, muscle cramps

tendon rupture

Disorders of reproductive organs and breast

incapacity

gynecomastia

General disorders and administration site conditions

asthenia, chest pain, back pain, peripheral edema, fatigue

discomfort, weight gain

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