Instruction for use: Biprol

Trade name of the drug – Biprol

Dosage Form: tablets

Active substance: Bisoprololum

ATX

C07AB07 bisoprolol

Pharmacotherapeutic group: Beta1-selective blocker [Beta-blockers]

The 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

I20 Angina [angina]: Heberden disease; Angina pectoris; The attack of angina pectoris; recurrent angina; Spontaneous angina; Stable angina pectoris; Angina rest; Angina progressing; Angina mixed; Angina spontaneous; stable angina; Chronic stable angina; Angina Syndrome X

I25 Chronic ischemic heart disease: Coronary heart disease on the background of hypercholesterolemia; Coronary heart disease is a chronic; Coronary heart disease; Stable coronary artery disease; Percutaneous transluminal angioplasty; Myocardial ischemia, arteriosclerosis; Recurrent myocardial ischemia

Composition (per tablet):

active substance: bisoprolol fumarate 2.5 mg; 5 mg; 10 mg

Other ingredients: MCC - 40 / 44.5 / 62.4 mg; ludipress LTSE (lactose monohydrate - 94,7-98,3% povidone - 3-4%) - 38.05 / 40 / 38.5 mg; corn starch - 7.2 / 8/11 mg; colloidal silicon dioxide (Aerosil) - 0.45 / 0.5 / 0.6 mg; crospovidone (Kollidon CL) - 0,9 / 1 / 1.25 mg; magnesium stearate - 0.9 / 1 / 1.25 mg

shell film: titanium dioxide - 0.43 / 0.287 / 0.43 mg; macrogol (polyethylene glycol 4000) - 0.2 / 0.287 / 0.43 mg; Hypromellose (hydroxypropyl) - 1.27 / 1.32 / 1.968 mg; talc - 0.1 / 0.106 / 0.172 mg

Pharmacological Properties of Biprol

Pharmachologic effect - antianginal, hypotensive, anti-arrhythmic.

Dosage and Administration

Common for all dosages

Inside, in the morning, 1 times a day with a small amount of liquid, before breakfast, during or after it. Tablets should not be chewed or triturate.

For tablets, film coated tablets, 2.5 mg

The prerequisites for the start of treatment Biprol are stable chronic heart failure without acute symptoms for 6 weeks; optimal treatment doses of drugs to standard therapy of CHF; no change in the standard therapy of CHF in the previous 2 weeks. Home treatment with Biprol necessarily require the special titration phase and regular medical supervision.

titration phase

Biprol recommended starting dose of the drug is 1.25 mg (Table 1.2., 2.5 mg), 1 time per day. Depending on individual tolerability, the dose should be gradually increased to 2.5; 3.75; 5; 7.5; 1 and 10 mg once a day. Any subsequent increase in the dose should be administered at intervals of at least 2 weeks. If an increase in the dose of the drug is poorly tolerated by the patient, the dose may be reduced. The maximum recommended (target) dose of the drug in CHF Biprol is 10 mg 1 time a day.

During the titration phase, requires regular monitoring of heart rate, blood pressure and symptoms of worsening heart failure trends that may develop from the first day of the drug.

Upon receiving the starting dose of 1.25 mg (2.1 Table 2.5 mg.) Of the patient should be monitored for 4 hours (control heart rate, blood pressure, conduction abnormalities, worsening symptoms of heart failure flow); preparation cancel if necessary.

Any increase in dose should be administered only if the previous well tolerated dose and the patient's condition stable. When questionable portability and excessive decrease in blood pressure, increase the dose 1 every 4 weeks; wherein the target dose can be achieved by the 24th week. If it is impossible to achieve the target dose, the patient should receive the maximum tolerated dose.

The titration period or maintenance therapy may experience a temporary worsening of heart failure, hypotension or bradycardia. In these cases, it is recommended to carry out the correction doses of concomitant therapy drugs (diuretic and / or ACE inhibitor); the ineffectiveness of this measure may require a temporary reduction, a slower titration of dose or withdrawal of the drug Biprol. Resumption of therapy and / or dose titration Biprol the drug should be considered only after stabilization of the patient's condition.

Do not allow a sudden discontinuation of the drug Biprol (or any beta-blocker), since it is possible the development of the syndrome, which manifests signs of decompensation of chronic heart failure. Therefore, the abolition and reduction of the dose Biprol drug should be made gradually, under medical supervision, taking into account the individual patient's reactions (see. "Special Instructions").

Omitting receiving regular doses of the drug should not double the next dose.

The duration of treatment. Biprol drug usually prescribed for long-term therapy, the duration of which is determined by your doctor.

Special patient groups

Impaired renal or hepatic function. If the kidney function or liver mild or moderate dose adjustment is required. In severe violations of the kidneys (Cl creatinine less than 20 mL / min) and in patients with severe liver disease dose titration is carried out with extreme caution; the maximum daily dose Biprol drug is 10 mg.

Elderly patients. Dose adjustment is not required.

Children. Due to lack of data Biprol use of the drug in children under 18 years of age is not recommended.

Patients with concomitant diseases. At present, insufficient data regarding the use of bisoprolol in patients with chronic heart failure in combination with type 1 diabetes, severe renal impairment and / or liver disease, restrictive cardiomyopathy, congenital heart defects or defects of the heart valves with severe hemodynamic disturbances, myocardial infarction within the last 3 months.

For tablets, film-coated, 5 and 10 mg

In all cases, the receiving mode and selects the dose the doctor for each patient individually, in particular taking into account the patient's heart rate and condition.

When hypertension and coronary heart disease the drug is prescribed 5 mg 1 time per day. If necessary to increase the dose of 10 mg 1 time per day. In the treatment of hypertension and angina maximum daily dose is 20 mg once a day one.

Impaired renal function. Patients with renal impairment (Cl creatinine <20 ml / min) or severe liver problems, the maximum daily dose is 10 mg 1 time per day. Increasing the dose in such patients should be carried out with extreme caution.

Elderly patients. Dose adjustment is not required.

Release Form

Tablets, film-coated, 2.5 mg. In blisters made of PVC film and aluminum foil printed lacquered, 10 pcs. 1, 2, 3, 5 or 10 contour of cellular packages in a stack of cardboard.

Tablets, film-coated, 5 mg and 10 mg. In blisters made of PVC foil and aluminum foil, 10 pieces. 3, 5 or 10 contour cell packages in paper cartons.

Manufacturer

Tablets, film-coated, 2.5 mg. "MAKIZ PHARMA" Ltd., Russia. 109029, Moscow, Prospect Road., 6, p. 5.

Tablets, film-coated, 5 mg and 10 mg. 1. LLC "MAKIZ PHARMA", Russia. 109029, Moscow, Prospect Road., 6, p. 5.

Name and address of the legal entity in whose name issued registration certificate / organization receiving the claim: JSC "Nizhpharm", Russia. 603950, Nizhny Novgorod, GSP-459, st. Salganskii 

Conditions of supply of pharmacies

On prescription.

Storage conditions of Biprol

In a dry, dark place at a temperature no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

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