STATINAM

Amlodipine + Atorvastatin

Composition: each film-coated tablet contains:

active substance:amlodipine (asamlodipine besilate) – 5 mg or 10 mg; atorvastatin (as atorvastatin calcium) – 10 mg.

Therapeutic indications

Statinam-Belmed is prescribed to the patients to whom the simultaneous treatment with amlodipine and atorvastatin is recommended.

Amlodipine.

Arterial hypertension: Amlodipine is indicated for treatment of arterial hypertension. The drug product is administered both as the monotherapy and in combination with the other antianginal or hypotensive drug products.

Ischaemic heart disease (IHD)

Chronic stable stenocardia: Amlodipine is indicated for treatment of chronic stable stenocardia. The drug product is administered both as the monotherapy and in combination with the other antianginal or hypotensive drug products.

Vasospasticstenocardia(Prinzmetal's angina or variant stenocardia):amlodipine is indicated for treatment of confirmed or in case of suspected vasospasticstenocardia. The drug product is administered both as the monotherapy and in combination with the other antianginal drug products.

Coronary artery disease confirmed by angiographic study (CAD): amlodipine is indicated for patients with coronary artery disease that has been recently confirmed by angiographic study and with no cardiac distress or with indicant ejection fraction <40% in order to reduce the risk of hospitalization because of stenocardia and to lower the risk of revascularization procedure.

Atorvastatin

Associated with a high-risk of atherosclerotic vascular disease development at hypercholesteremia it is recommended to administer atorvastatin in patients with multiple risk factors. It is recommended to provide treatment with drug products if the response to therapeutic diet is lowering that is referred to saturated fat and cholesterin reduction and also in case of insufficiency of other drug-free methods. In patients with coronary artery insufficiency or multiple risk factors coronary artery insufficiency development the treatment of Statinam-Belmed component of atorvastatin may be started together with therapeutic diet.

Atorvastatin is recommended to be taken for cardiovascular disease prevention to:

   -   reduce risk of myocardial infarction;

   -   reduce risk of apoplectic attack;

   -   reduce risk of revascularization and stenocardia

In patients with type 2 diabetes with no clinical evidence of coronary artery insufficiency with the several risk factors of coronary artery insufficiency (for instance: retinopathy, albuminuria, smoking or hypertension) atorvastatin is indicated to:

   -   reduce risk of myocardial infarction;

   -   reduce risk of apoplectic attack;

In patients with clinical evidence of coronary artery insufficiency atorvastatin is indicated to:

   -   reduce risk of nonfatal myocardial infarction;

   -   reduce risk of fatal and nonfatal apoplectic attack;

   -   reduce risk of revascularization;

   -   reduce risk of hospitalization with backward heart failure;

   -   reduce risk of stenocardia development

Heterozygous heritable and nonheritable hypercholesterolemia:

Atorvastatin is indicated as supplement to the diet in order to reduce higher level of total cholesterol, LDL, apoB and triglycerids and also to increase HDL in patients with primaryhypercholesteremia (heterozygous heritable and nonheritable) with mixed dislipidemy (type IIa and IIb according to Fredricson’s classification);

Increased level of triglycerids in blood serum: Atorvastatin is indicated in combination with the diet in order to lower the higher level of triglycerids in blood serum (type IV according to Fredricson’s classification);

Primarydysbetalipoproteinemia: Atorvastatin is indicated for treatment of patients with primarydysbetalipoproteinemia if the diet does not have any appropriate effect;

Homozygous heritable hypercholesterolemia: Atorvastatin is indicated in order to reduce the higher level of total cholesterol and LDL in patients with homozygous heritable hypercholesterolemia in combination with other drug products which reduce the level of lipids (for example: apheresis of LDL) or if such treatment is impossible.

	АТС code
	C10BX03
	Pharmaceutical form
	film-coated tablets 5mg/10mg, 10mg/10mg
	Storage conditions
	Store in protected from moisture and light place at temperature below 30°C.