ATORGAMA table. 40 mg

INDICATION:

Atorgamma be used in addition to a change in diet, ss to reduce elevated total cholesterol, cholesterol LDL, apolipoprotein B and triglycerides in patients with primary hypercholesterolaemia, 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, for example with other reducing LDL cholesterol drugs, or if they did not achieve satisfactory results after another led to treatment to reduce total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia.

DOSAGE AND ADMINISTRATION:

Patients should undergo a standard diet holesterolponizhavashta before being prescribed Atorgamma, it is necessary to continue the diet and during treatment with Atorgamma. Dosage should be individualized, depending on baseline cholesterol LDL, the goal of therapy and response.

The usual starting dose is 10 mg once daily. Dosage adjustments should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once daily. Doses should be taken at any time during the day with or without food.

Primary hypercholesterolaemia and combined hyperlipidaemia

The appropriate dose for most patients is 10 mg. Proven is a response within 2 weeks, and maximum response is usually achieved within 4 weeks. The answer remains in treatment.

Heterozygous familial hypercholesterolemia

The starting dose is 10 mg per day. Dosage 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 40 mg daily, but in combination with a bile acid chelating agents.

Homozygous familial hypercholesterolemia

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

Patients with homozygous familial hypercholesterolemia received atorvastatin at doses of 10-80 mg daily, in addition to other lipid-lowering therapy in the blood, in cases where no satisfactory results have been achieved by other treatment.

Patients with impaired renal function

Kidney disease does not affect either the plasma or the effect of atorvastatin on blood lipids and therefore does not require dose adjustment.

Elderly

The efficacy and safety when used in recommended doses for patients over 70 years are similar as for other adults.

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 restricted to a small group of patients with severe hyperlipidemia abnormal as homozygous familial hypercholesterolemia. The recommended starting dose for these patients is 10 mg atorvastatin daily. Based on the response and tolerance, the dose may be increased to 80 mg daily. There 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 elevated serum transaminases

Patients with myopathy

Pregnancy and lactation

 Women of childbearing age who do not use contraceptives

Pregnancy and lactation

Atorgamma is contraindicated during pregnancy and lactation. Women of childbearing age should use effective contraception during treatment.

The safety profile of atorvastatin when used during pregnancy and lactation has not been established.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Atorvastatin is not known to affect ability to drive and use machines.

SIDE EFFECTS

The most common adverse reactions that can be expected are symptoms of gastrointestinal system, including constipation, flatulence, dyspepsia, and abdominal pain that resolved with continued treatment. Less than 2% of patients were excluded from klinichini trials due to adverse events 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:

Rare - 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 sulfate, silica colloidal anhydrous, magnesium stearate.

Tablet coating:

hypromellose 6 cP, titanium dioxide