Instruction for use: Nortivan

Dosage form: film coated tablets

Active substance: Valsartanum

ATX

C09CA03 Valsartan

Pharmacological group

Angiotensin II receptor antagonist [Angiotensin II receptor antagonists (AT1-subtype)]

Nosological classification (ICD-10)

I10 Essential (primary) hypertension: hypertension; Arterial hypertension; Arterial hypertension crisis course; Essential Hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Primary hypertension; Arterial hypertension, complications of diabetes; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; arterial Hypertension; malignant Hypertension; Hypertonic disease; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; Isolated systolic hypertension

I15 Secondary hypertension: Arterial hypertension, complications of diabetes; hypertension; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; hypertension; arterial Hypertension; malignant Hypertension; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; hypertension; Arterial hypertension; Arterial hypertension crisis course; renovascular hypertension; Hypertension symptomatic; Renal hypertension; Renovascular hypertension; renovascular hypertension; Symptomatic hypertension

I21.9 Acute myocardial infarction, unspecified: Changes in left ventricle with myocardial infarction; Changes in the left atrium with myocardial infarction; Myocardial infarction; Myocardial infarction without Q wave; Myocardial infarction without signs of chronic heart failure; Myocardial infarction with unstable angina; Pirouette tachycardia with myocardial infarction

I50.1 Left ventricular failure: Cardiac asthma; Asymptomatic dysfunction of the left ventricle; Asymptomatic left ventricular heart failure; Diastolic dysfunction of the left ventricle; Left ventricular dysfunction; Changes in the left ventricle with myocardial infarction; Left ventricular heart failure; Violation of the function of the left ventricle; Acute left ventricular failure; Acute cardiac left ventricular failure; Cardiac asthma; Heart failure of left ventricular; Changes in the lungs with left ventricular failure; Precordial abnormal pulsation; Lack of left ventricle

I50.9 Heart failure, unspecified: Diastolic rigidity; Diastolic heart failure; Cardiovascular failure; Heart failure with diastolic dysfunction; Cardiovascular failure

Composition

Tablets covered with a film coating.

active substance: Valsartan 40 mg; 80 mg; 160 mg

Auxiliary substances: MCC - 35.6 / 71.2 / 142.4 mg; Crospovidone - 19.75 / 39.5 / 79 mg; Silicon dioxide colloidal - 5,3 / 10,6 / 21,2 mg; Magnesium stearate - 1.875 / 3.75 / 7.5 mg

Film sheath

Tablets 40 mg: Opadry TAN 03B34653 (hypromellose 6sp - 3,125, titanium dioxide (E171) - 1.43 mg, macrogol 400 - 0.312 mg, talc - 0.05 mg, iron oxide yellow oxide (E172) - 0.073 mg, iron dye Red oxide (E172) 0.008 mg, ferric iron oxide black (E172) 0.002 mg) 5 mg

Tablets 80/160 mg: Opadry PINK 03B34654 (hypromellose-6sR - 6.25 / 12.5 mg, titanium dioxide (E171) - 2.691 / 5.383 mg, macrogol 400 - 0.625 / 1.25 mg, talc 0.1 / 0.2 mg, ferric iron oxide yellow (E172) 0.146 / 0.292 mg, iron oxide red (E172) 0.188 / 0.375 mg) 10/20 mg

Pharmachologic effect

Mode of action - antihypertensive.

Dosing and Administration

Inside, regardless of food intake, the frequency of reception - 1-2 times a day.

Arterial hypertension

For most patients, the recommended dose of Nortivan® is 80 mg / day, regardless of the age, sex or race of the patient. The hypotensive effect is manifested during 2 weeks of therapy, and the maximum effect is observed after 4 weeks of therapy.

In some patients who cannot achieve the target blood pressure, the dose can be increased to 160 mg / day. Further increase in antihypertensive effects can be achieved either by increasing the dose of Nortivan® to a maximum of 320 mg / day, or by adding Nortivan® thiazide diuretics to therapy.

Nortivan® can also be used concomitantly with other antihypertensive agents.

Use in patients older than 75 years

It is recommended to start treatment with a lower dose of 40 mg / day.

Use in patients with impaired renal function

In patients with impaired renal function (Cl creatinine less than 20 ml / min) or who are on hemodialysis, it is recommended to begin treatment with a lower dose of 40 mg / day.

In patients with impaired renal function (Cl creatinine 20-50 ml / min), correction of the initial dose of the drug is not required.

Use in patients with reduced BCC

For patients with reduced BCC (for example, patients receiving treatment with high doses of diuretics whose dose of diuretic cannot be reduced), the initial dose of Nortivan® is 40 mg / day.

Use in patients with impaired liver function

Patients with mild to moderate hepatic insufficiency (less than 9 on the Child-Pugh scale) are given a recommended initial dose of 40 mg / day. The maximum daily dose is 80 mg. Do not exceed the daily dose of 80 mg.

Use in patients after a previous myocardial infarction

Therapy can be started already in the first 12 hours after an acute myocardial infarction in an initial dose of 20 mg (1/2 tablet to 40 mg) twice a day, possibly a gradual increase in the dose of Nortivan® (40, 80 mg) for several weeks Until the maximum dose of 160 mg twice a day, taking into account the tolerability of the drug.

If you detect arterial hypotension or a violation of kidney function, you should consider reducing the dose of the drug.

Nortivan® can be used in patients receiving standard therapy after a previous myocardial infarction, including acetylsalicylic acid, β-blockers, inhibitors of HMG-CoA reductase.

When using Nortivan® after a myocardial infarction in patients with impaired renal function (Cl creatinine 20-50 ml / min), dose adjustment is not required.

Currently, there are no data on the use of the drug after a previous myocardial infarction in patients with severe renal insufficiency (creatinine concentration ≥221 μmol / l). For this reason, Nortivan® should be used in such patients with caution, with an appropriate assessment of renal function.

Release form

Tablets, film-coated, 40 mg, 80 mg, 160 mg. In the blister, aluminum / aluminum for 10 pcs. 3 blisters in a cardboard box.

Manufacturer

Gedeon Richter

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Nortivan

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

The shelf life of the drug Nortivan

3 years.

Do not use beyond the expiration date printed on the package.