PRO.MED.CS Praha a.s.

 

The following information is for health professionals only.
READ CAREFULLY THIS NOTICE!

Characteristics:

Bisoprolol is a highly cardioselective beta-blocker of adrenergic receptors without internal sympathomimetic activity (ISA), exerting antihypertensive, negatively inotropic and negatively chronotropic effects. Bisoprolol is well absorbed after oral administration; 50% is metabolized in the liver and the rest is excreted unchanged via the kidneys. Its biological half-life is 10-12 hours.

Indications:

Arterial hypertension; IHD: exertion angina pectoris, mute myocardial ischemia, unstable angina pectoris; subacute stage of myocardial infarction (in the acute stage, a beta-blocker with a shorter period of action is to be preferred); conditions after survival of myocardial infarction; in combination with nitrates or calcium antagonists it can be administered also in variant angina pectoris; disorders in cardiac rhythm, particularly its tachyarrhythmic form (supraventricular as well ventricular, fibrillation or flutter of the atria). Adults and children over 12 of age.

Contraindications:

Hypersensitivity to bisoprolol and auxiliary substances, acute deterioration of cardiac failure, shock, AV block of the 2nd and 3rd degree, sick sinus syndrome, serious sinoatrial block, bradycardia (below 50/min prior to the commencement of treatment), hypotension (systolic pressure below 90 mm Hg), asthma bronchiale, COPD, Raynaud’s syndrome, simultaneous administration of MAO inhibitors (except MAO - B inhibitors).
Caution is necessary in ischemic disease of the lower extremities in the stage of claudications or trophic changes, in diabetics, metabolic acidosis, AV block of the 1st degree, Prinzmetal’s angina, pheochromocytoma, allergic and psoriatic patients. Preparation should not be administered in gravidity and lactation.

Undesirable effects:

At the beginning of treatment, there may occur fatigue, headaches, vertigo, sleep disorders, psychic changes (depressive moods and suchlike). Occasionally orthostatic hypotension, bradycardia, transmission disorders, paresthesia, deterioration of troubles in patients with intermittent claudications or Raynaud’s syndrome, and breathlessness in patients with asthma bronchiale can be observed.

Interactions:

Bisoprolol intensifies hypotension when administered simultaneously with other antihypertensive agents. Simultaneous administration of reserpine, alpha-methyldopa, clonidine, digitalis, or guanfacin may induce bradycardia. Clonidine, digitalis or guanfacin may induce delayed transmission of cardiac impulse. In combination with calcium antagonists of verapamil type or some antiarrhythmic agents, bradycardia, transmission disorders or cardiac failure may occur. In combination with calcium antagonists of nifedipine type or with other vasodilating agents, it may induce hypotension.

Caution:

In diabetic patients bisoprolol may obscure the symptoms of hypoglycemia (tachycardia, tremor, sweating). Prior to an operation, the anesthesiologist must be informed about bisoprolol treatment.

Dosage:

Treatment starts with 5-10 mg of bisoprolol in a single, usually morning dose. In case the effect is insufficient, the dose can be increased up to 20 mg a day. In patients with severe affection of the liver and kidneys (creatinine clearance below 20 ml/min), the daily dose of 10 mg should not be exceeded. Bisoprolol treatment is a long-term one and must be terminated by gradual decrease in the dosage. Tablets a swallowed complete, in the morning on an empty stomach ore with meals with a sufficient volume of a liquid.

Package:

30 coated tablets of 5 mg,
30 coated tablets of 10 mg.

For greater details about the preparation see the product data summary.
Date of the latest revision of the text: January 16, 2008.
The preparation is available for medical prescription only and the price is fully covered by health insurance.

• Company profile
  • Who we are
  • History
  • Range
  • Quality care
  • Research and development
  • Position on the market
  • Co-operation with partners
• Products
  • Products by disease
  • Non-prescription drugs
  • Vitamins and minerals
• News
  • New products
  • About us
• Jobs
• Activities
  • International symposia of gastroenterology
  • Sponsoring
  • Round table
• Contact
  • Contact
  • Info line
• Homepage