Medicinal Products

ATORVASTATIN BLUEFISH 20 mg

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

Divisible coated tablet
Box of 90 film-coated tablets
All forms

Indication

hypercholesterolemia

Atorvastatin 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 heterozygous familial primary hypercholesterolemia, mixed hyperlipidemia (such as IIa, IIb according to Fredrickson's classification), when the response to diet alone or to other non-pharmacological measures is inadequate.

Atorvastatin is also indicated for lowering LDL-C and total cholesterol levels in patients with homozygous familial hypercholesterolemia, in combination with other treatments (eg LDL Apheresis) or when such treatments are not available.

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 BLUEFISH 20 mg Film-coated tablet scored Box of 90 film-coated tablets

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

The dosage should be adjusted according to the initial levels of LDL cholesterol, the objective and the response to the treatment of each patient.

The starting dose is 10 mg once a day. Dosage adjustment should be within a minimum interval of 4 weeks. The maximum dosage is 80 mg once a day.

Taking atorvastatin will be done at one time, regardless of the time of day, during or after meals.

Primary hypercholesterolemia and 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 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. The dosage may however be increased up to 80 mg per day. A bile acid chelator may also be prescribed in combination while maintaining a dosage of atorvastatin 40 mg per day.

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 should be used in combination or not with other lipid-lowering treatments such as LDL cholesterol apheresis (in case of unavailability of this type of treatment).

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.

Dosage in patients with renal insufficiency.

Renal function abnormalities have no influence on the plasma concentrations of atorvastatin. It is the same for the effects of lipids on atorvastatin. As a result, no dosage adjustment is necessary.

Dosage in patients with hepatic insufficiency

Atorvastatin should be used with caution in patients with hepatic impairment (see Warnings and Precautions and Pharmacokinetic Properties sections). It is contraindicated in patients with ongoing 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 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 daily have not been studied in children under 18 years of age.

The impact of treatment on development (safety data) has not been studied in this population.

For oral administration.

Against indications

Atorvastatin is contraindicated in patients with the following characteristics:

· Hypersensitivity to the active substance or to any of the excipients

· Have active liver disease or patients with unexplained persistent elevations of serum transaminases greater than 3 times the upper limit of normal.

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

Atorvastatin Bluefish side effects

The most common side effects are mainly gastrointestinal, including constipation, flatulence, dyspepsia, abdominal pain; these effects usually improve with continued treatment.

Less than 2% of patients were excluded from clinical trials because of atorvastatin-related adverse events.

The following adverse reactions observed with atorvastatin are from clinical studies and significant experience gained since product marketing.

The estimated frequencies of events are classified according to the following convention: frequent (≥ 1/100, <1/10); infrequent (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (≤ 1/10 000).

Blood and lymphatic system disorders

Uncommon: thrombocytopenia

Immune system disorders

Frequent: allergic reactions

Very rare: anaphylaxis.

Metabolism and nutrition disorders

Uncommon: hyperglycemia, hypoglycemia

Psychiatric disorders

Frequent: insomnia

Nervous system disorders

Frequent: headache, dizziness, paresthesia, hypoaesthesia

Uncommon: peripheral neuropathy, amnesia

Very rare: dysgeusia

Eye disorders

Very rare: Visual disturbances

Affections of the ear and labyrinth

Uncommon: Tinnitus

Very rare: hearing loss

Gastrointestinal disorders

Common: constipation, flatulence, dyspepsia, abdominal pain, nausea, diarrhea

Uncommon: anorexia, vomiting, pancreatitis

Hepatobiliary disorders

Rare: hepatitis, cholestatic jaundice

Very rare: liver problems

Skin and subcutaneous tissue disorders

Common: rash, pruritus

Uncommon: urticaria, alopecia

Rare: bullous erythema (including erythema multiforme)

Very rare: angioneurotic edema, Stevens-Johnson syndrome and toxic epidermal necrosis

Musculoskeletal and systemic disorders

Frequent: myalgia, arthralgia

Uncommon: myopathy

Rare: myositis, rhabdomyolysis, muscle cramps

Very rare: tendinopathy can be complicated by rupture

Disorders of reproductive organs and breast

Uncommon: impotence

Very rare: Gynecomastia

General disorders and administration site conditions

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

Uncommon: discomfort, weight gain.

investigations

An increase in serum transaminase levels has been reported in patients treated with atorvastatin. These increases are usually small and transient, and do not require discontinuation of treatment. Increases in clinically significant serum transaminases (> 3 times the upper limit of normal) were observed in 0.8% of patients treated with atorvastatin. These increases were dose-dependent and 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.

Levels 10 times higher than the upper limit were reported in 0.4% of atorvastatin-treated patients (see Warnings and Precautions ).

The following side effects have been reported with some statins:

· Sleep disorders with nightmares,

· memory loss,

· Sexual disorders,

· Depression.

Exceptional cases of interstitial lung disease, especially during long-term treatment (see Warnings and precautions for use ).

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