Medicinal Products

ATORVASTATIN ARROW LAB 40 mg tablet box of 90

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

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Indication

HypercholestÚrolÚmie

ATORVASTATIN is indicated in addition to a regimen for reducing the rates of total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in adults, adolescents and children ≥10 years of age with primary hypercholesterolesthesia including Familial hypercholesterolemia (heterosergote) or mixed hyperlipidemia (corresponding to types IIa and IIb of the Fredrickson classification), when the response to a regimen 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 hypercholesterolesthesia in combination with other hypolipidemic treatments (including LDL aphorosis) or if such treatments are unavailable.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in adult patients at risk of presenting a first cardiovascular event, in addition to the correction of other risk factors.

Dosage ATORVASTATINE ARROW LAB 40 mg Tablet boast 90

HypercholestÚrolÚmie

ATORVASTATIN is indicated in addition to a regimen for reducing the rates of total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in adults, adolescents and children ≥10 years of age with primary hypercholesterolesthesia including Familial hypercholesterolemia (heterosergote) or mixed hyperlipidemia (corresponding to types IIa and IIb of the Fredrickson classification), when the response to a regimen 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 hypercholesterolesthesia in combination with other hypolipidemic treatments (including LDL aphorosis) or if such treatments are unavailable.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in adult patients at risk of presenting a first cardiovascular event, in addition to the correction of other risk factors.

Against indications

ATORVASTATIN is contraindicated in patients:

- showing hypersensitivity to the active substance or to any of the excipients of this medicinal product

- with a progressive liver disease or with persistent and unexplained elevations of serum transaminases greater than three times the upper limit of normal

- in pregnant, lactating or elderly women who are not using a reliable contraceptive method (see section Pregnancy and breastfeeding ).

Side effects Atorvastatin Arrow Lab

In the controlled clinical trials comparing the effect of atorvastatin to placebo in 16066 patients (8755 patients treated with ATORVASTATIN ARROW LAB, 7311 patients receiving placebo) treated for an average duration of 53 weeks, 5.2 % of patients treated with atorvastatin discontinued treatment due to adverse effects, compared to 4.0% of patients receiving placebo.

The undesirable effects presented here with atorvastatin are the result of clinical studies and the significant experience gained since the product was marketed.

The estimated frequencies of undesirable effects are classified according to the following convention: frequent (≥ 1/100, <1/10); not very frequent (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (≤ 1/10000); indefinite frequency (can not be estimated on the basis of available data).

Infections and infestations

Frequent: nasopharyngitis.

Hematological and lymphatic system disorders

Rare: thrombocytopenia.

Immune system disorders

Frequent: allergic reactions.

Very rare: anaphylaxis.

Metabolism and nutrition disorders

Frequent: hyperglycemia.

Few frequent: hypoglycemia, weight gain, anorexia.

Psychiatric disorders

Not very frequent: nightmares, insomnia.

Nervous System Affections

Frequently: cÃphalÚes.

Few: vertigo, paresthesia, hypoesthesia, dysgeusia, amnesia.

Rare: Peripheral neuropathy.

Eye disorders

Not very frequent: blurred vision.

Rare: visual disturbances.

Affections of the ear and labyrinth

Few frequent: tinnitus.

Very rare: hearing loss.

Respiratory, thoracic and mediastinal disorders

Frequent: pharyngolaryngeal pain, Úpistaxis.

Gastrointestinal disorders

Frequent: constipation, flatulence, dyspepsia, nausea, diarrhea.

Few common: vomiting, upper and lower abdominal pain, Úructation, pancrÚatitis.

Hospital diseases

Few frequent: hepatitis.

Rare: cholestasis.

Very rare: hepatic insufficiency.

Skin and subcutaneous tissue disorders

Few common: urticaria, rash, pruritus, alopecia.

Rare: angioneurotic edema, bullous dermatosis including polymorphic erythema, Stevens-Johnson syndrome, and Lyell's syndrome.

Musculoskeletal and connective tissue disorders

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

Not very common: neck pain, muscle fatigue.

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

Indeterminate frequency: Necrotizing myopathy with autoimmune mediation (see Warnings and Precautions )

Disorders of reproductive organs and breast

Very rare: gynÊcomastie.

General disorders and administration site abnormalities

Few: malaise, asthenia, chest pain, peripheral oedezia, fatigue, pyrexia.

investigations

Frequent: abnormalities of the tests of the hepatic function, increase of the blood level of the creatine phosphokinase.

Not very common: leucocyturia.

As with other HMG-CoA reductase inhibitors, increases in serum transaminase levels have been reported in patients receiving ATORVASTATIN ARROW LAB. These changes are usually mild and transient and do not need to be discontinued.

Clinically significant increases (> 3 times the upper limit of normal) of serum transaminase levels were observed in 0.8% of patients treated with ATORVASTATIN ARROW LAB. These increases were dose-dependent and reversible in all patients.

An increase in the serum creatine phosphokinase (CPK) level by more than three times the upper limit of normal was observed in 2.5% of patients receiving ATORVASTATIN ARROW LAB, a proportion similar to that observed with other inhibitors of HMG-CoA reductase in clinical studies.

Serum rates greater than ten times the upper limit of normal were found in 0.4% of patients treated with ATORVASTATIN ARROW LAB (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 an age group of 6 At 9 years, and 228 patients were in an age range of 10 to 17 years.

Nervous System Affections

Frequently: cÃphalÚes.

Gastrointestinal disorders

Frequent: abdominal pain.

investigations

Frequent: increase of alanine aminotransferase, increase of blood phosphokinase creatine.

On the basis of the available data, the frequency, type and severity of undesirable reactions in children are expected to be identical to those in adults. The experience regarding long-term safety in the pediatric population is currently limited.

The following undesirable 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 glycemia at 5.6 mmol / l, BMI> 30 kg / m 2, increased triglyceride levels, antecedents arterial hypertension).

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals declare any suspected adverse effects via the national system of declaration: 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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