ATORGAMMA. 20 mg. 56 tablets

INDICATION:
Atorgamma be used in addition to a change in diet, cc to reduce elevated total cholesterol, cholesterol LDL, apolipoprotein B and triglycerides in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined hyperlipidemia, if not achieved satisfactory results after held a special diet or other medications.

Atorgamma be used in combination therapy, e.g., with other reducing LDL cholesterol medicines or in the event that they have not achieved satisfactory results after other treatment performed to reduce total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia.

DOSAGE AND ADMINISTRATION:
Patients should be subjected to the standard diet holesterolponizhavashta before being prescribed Atorgamma, it is necessary to continue your diet during treatment with Atorgamma. The dosage should be adjusted individually depending on the base values of cholesterol in LDL, the target of treatment and therapeutic response.

The usual starting dose is 10 mg once daily. Dosage adjustment should be carried out at intervals of 4 weeks or more. The maximum dose is 80 mg once daily. The daily dose should be taken once in each time of the day, with or without food.

Primary hypercholesterolemia and combined hyperlipidemia
A suitable dose for most patients is 10 mg. Is a proven therapeutic response within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks. The answer is preserved during prolonged therapy.

Heterozygous familial hypercholesterolemia
The initial dose is 10 mg per day. The dose should be individualized for each patient and adjusted at intervals of 4 weeks to 40 mg daily. The dose of atorvastatin may be increased or 80 mg daily, or up to 40 mg daily, but in combination with a bile acid chelating agents.

Homozygous familial hypercholesterolemia
In a study of 64 patients, of which 46 with homozygous familial hypercholesterolemia, atorvastatin was administered at doses up to 80 mg. For these 46 patients, the median reduction in LDL cholesterol was 21%

Patients with homozygous familial hypercholesterolemia atorvastatin at doses of 10-80 mg per day, in addition to other lipid-lowering therapy in the blood, in the cases where they are not given satisfactory results to other treatments.

Patients with impaired renal function
Renal diseases affect neither the plasma concentration nor the effect of atorvastatin on blood lipids and therefore does not require dose adjustment.

Elderly
The efficacy and safety for use in the recommended doses for patients over 70 years, such as in other elderly patients.

Children and adolescents
Use in children should be carried out under the supervision of a specialist.
Experience in the use of this medicine in children is limited and confined to a small group of patients with serious abnormal hyperlipidemia as homozygous familial hypercholesterolemia. The recommended starting dose in this group of patients is 10 mg atorvastatin daily. Based on the therapeutic response and tolerance, the dose may be increased up to 80 mg daily. Not analyzed data on the safety and effects on the development of this group of patients using atorvastatin.

CONTRAINDICATIONS:
Atorgamma is contraindicated in:
- Patients with a history of hypersensitivity to the active substance or to any of the excipients
- Patients with active liver disease or unexplained high levels of serum transaminases
- Patients with myopathy
- Pregnancy and lactation
- Women of reproductive age who do not use contraceptives

Pregnancy and lactation
Atorgamma is contraindicated during pregnancy and lactation. Women of reproductive age should implement effective contraception during treatment.
The safety profile of atorvastatin use during pregnancy and lactation has not been established.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
Atorvastatin is not known to affect your ability to drive and use machines.

SIDE EFFECTS
The most common adverse reactions that may be expected symptoms of the gastrointestinal system, including constipation, flatulence, dyspepsia and abdominal pain that resolved during treatment. Less than 2% of the patients were excluded from the trials klinichini resulting in adverse effects associated with atorvastatin

Blood and lymphatic system disorders:
Uncommon - thrombocytopenia

Nervous system disorders:
Common - headache, dizziness, paraesthesia, hypoaesthesia
Uncommon - Peripheral neuropathy

Ear and labyrinth disorders:
Uncommon - tinnitus

Gastrointestinal disorders:
Common - constipation, flatulence, dyspepsia, nausea, diarrhea
Uncommon - anorexia, vomiting

Skin and subcutaneous tissue disorders:
Common - rash, itching
Uncommon - urticaria
Very rare - angioedema, bullous eruptions

Musculo-skeletal and connective tissue disorders:
Common - mialgaya, arthralgia
Uncommon - myopathy
Rare - myositis, rhabdomyolysis

Endocrine disorders:
Uncommon - alopitsiya, hyper-or hipoglikeziya, pancreatitis

General disorders and administration site conditions:
Common - fatigue, chest pain, back pain, peripheral edema
Uncommon - malaise, weight display

Immune system disorders:
Common - hypersensitivity
Very rare - anaphylaxis

Hepatobiliary disorders:
Rarely - hepatitis, cholestatic jaundice

Reproductive system and breast disorders:
Uncommon - impotence

Psychiatric disorders:
Common - insomnia
Uncommon - amnesia


LIST OF OTHER INGREDIENTS:
Core:
mannitol, microcrystalline cellulose, calcium carbonate, povidone, croscarmellose sodium, sodium lauryl sulphate, silica colloidal anhydrous, magnesium stearate.
Tablet coating:
hypromellose 6 cP, Titanium dioxide