Medicinal Products

ATORVASTATIN RANBAXY PHARMA G 80 mg

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

Coated tablet
Box of 90
All forms

Indication

hypercholesterolemia

ATORVASTATIN RANBAXY PHARMACIE GENERIQUES is indicated in addition to a diet adapted to reduce the high levels of total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, children and adolescents. adolescents and children over 10 years of age with primary hypercholesterolemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidemia (corresponding to Fredrickson's Types IIa and IIb), when the response to diet or other non-pharmacological measures are not sufficient.

ATORVASTATIN RANBAXY PHARMACIE GENERIQUES is also indicated for the reduction of total cholesterol and LDL-C levels in adult patients with homozygous familial hypercholesterolemia, in combination with other lipid-lowering drugs (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 5.1 Pharmacodynamic properties ), in combination with corrective treatments for other risk factors.

Dosage ATORVASTATIN RANBAXY PHARMA G 80 mg Film-coated tablet Box of 90

Dosage

The patient should follow a standard cholesterol-lowering diet before starting treatment with ATORVASTATIN RANBAXY PHARMACIE GENERIQUES and should continue this regimen for the duration of treatment with ATORVASTATIN RANBAXY PHARMACIE GENERIQUES.

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

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

Primary hypercholesterolemia and combined (mixed) hyperlipidemia

The majority of patients are controlled by ATORVASTATIN RANBAXY PHARMACY GENERIC 80 mg once daily. A therapeutic effect is observed after two weeks and the maximum therapeutic response is usually reached within 4 weeks. The effect is maintained in case of prolonged treatment.

Heterozygous familial hypercholesterolemia

Treatment of patients taking ATORVASTATIN RANBAXY PHARMACIE GENERIQUES will be initiated at a dose of 10 mg once daily. The dosage will then be individually adjusted every 4 weeks up to 40 mg once a day. Thereafter, the dosage may be increased to a maximum of 80 mg once daily or a bile acid sequestrant may be combined with 40 mg of atorvastatin 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 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 apheresis) or when such treatments are not available.

Prevention of cardiovascular diseases

In primary prevention studies, the dosage was 10 mg / day. Higher dosages may be required to achieve the LDL cholesterol targets set by current guidelines.

Renal insufficiency

No dose adjustment is required in patients with renal impairment (see Warnings and Precautions ).

Hepatic insufficiency

ATORVASTATIN RANBAXY PHARMACIE GENERIQUES should be used with caution in patients with hepatic impairment (see sections Warnings and Precautions for Use and Pharmacokinetic Properties ). ATORVASTATIN RANBAXY PHARMACIE GENERIQUES 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.

Pediatric use

Hypercholesterolemia:

Pediatric use should be reserved for specialists and the effectiveness of treatment should be evaluated regularly.

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

ATORVASTATIN RANBAXY PHARMACY GENERIC is a drug for oral administration. Each daily dose of atorvastatin is administered once daily and can be taken at any time of the day, during or after meals.

Against indications

ATORVASTATIN RANBAXY PHARMACY GENERIC is contraindicated in patients with the following characteristics:

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

· Have active liver disease or unexplained persistent increases in 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 ).

Adverse Reactions Atorvastatin Ranbaxy Pharma G

In controlled clinical studies comparing the effect of atorvastatin with placebo in 16066 patients (8755 atorvastatin-treated versus 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 undesirable effects presented below observed with ATORVASTATIN RANBAXY PHARMACIE GENERIQUES come from clinical studies and the experience gained since the commercialization of the molecule.

The estimated frequency of these effects is established according to the following convention: 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: hypoglycaemia, 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, tendonopathy, 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 treated with ATORVASTATIN RANBAXY PHARMACIE GENERIQUES. 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 RANBAXY PHARMACIE GENERIQUES. These increases were dose-dependent and reversible in all patients.

Increased serum creatine phosphokinase (CPK) by more than three times the upper limit of normal was observed in 2.5% of patients treated with ATORVASTATIN RANBAXY PHARMACY GENERIC, a proportion similar to that seen with other HMG-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 RANBAXY PHARMACIE GENERIQUES (see Warnings and Precautions ).

The following side effects have been reported for some statins:

· Sexual disorders.

· Depression.

· Exceptional cases of interstitial lung disease, especially during long-term treatment (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

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.

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