BIROLEN [Bisoprolol] 5 mg Film-coated tablets
Instructions for the medical use of the medicinal product
BIROLEN
Tradename
Birolen, Birolen
International non-proprietary name
Bisoprolol Fumarate USP , Bisoprolol Fumarate USP
Compound
Each film-coated tablet contains:
active substance: bisoprolol fumarate USP 5 mg
excipients : Q. S Colour: Titanium Dioxide BP
Each film-coated tablet contains:
active substance: bisoprolol fumarate USP 10 mg
excipients : Q. S Colour: Titanium Dioxide BP
Dosage form
Tablets.
Pharmacological properties Mechanism of action
Bisoprolol is a potent, highly selective beta1-adrenoblocker that does not have internal stimulation and does not have the corresponding membrane stabilizing activity. He shows low affinity only for beta2 receptors of bronchial and vascular smooth muscles, as well as for beta2 receptors, related With regulation metabolism. So Thus, bisoprolol generally does not affect airway resistance and beta2-mediated metabolic effects. Its beta1 selectivity goes beyond limits therapeutic range doses.
Indications for use
Treatment of hypertension
Treatment of stable chronic angina pectoris
Treatment stable chronic cardiac insufficiency with reduced systolic function of the left ventricle in addition to inhibitors ACE, diuretics and optional cordial glycosides.
Contraindications
Bisoprolol is contraindicated in patients with chronic heart failure with:
• acute cardiac failure or at episodes of decompensated heart failure requiring i/v introductions inotropic therapy
• cardiogenic shock
• AV block second or third degree (without pacemaker)
• syndrome weaknesses sinus node
• sinoatrial blockade
• Symptomatic bradycardia
• Symptomatic hypotension
• heavy bronchial asthma or heavy chronic obstructive disease lungs
• late stages occlusal disease peripheral arteries and syndrome Raynaud
• untreated pheochromocytoma
• metabolic acidosis
• hypersensitivity to the active substance or to anyone from auxiliary substances.
Special instructions and precautions
Special Warnings:
It is used only in chronic heart failure:
Treatment stable chronic cardiac insufficiency with bisoprolol should begin with a special titration phase.
Applies to all indications:
Especially in patients with ischemic heart disease, discontinuation of bisoprolol therapy should not be abrupt, unless clearly indicated, as this may lead to a transient worsening of the heart condition.
Precautionary measures:
Only used for hypertension or angina pectoris: Bisoprolol should apply With caution at patients with arterial hypertension or angina pectoris and concomitant cardiac insufficiency.
It is used only in chronic heart failure:
At the beginning of treatment with bisoprolol, regular monitoring is necessary. Dosage and method of application, please.
There is no therapeutic experience in the treatment of heart failure with bisoprolol in patients with following diseases and states:
• insulin dependent sugar diabetes ( I type of),
• heavy violations functions kidney,
• heavy violations functions liver,
• restrictive cardiomyopathy,
• birth defects hearts,
• hemodynamically significant organic valve defects,
• heart attack myocardium in flow 3 months
Applies to all indications:
Bisoprolol should be used with caution in:
• bronchospasm (bronchial asthma, obstructive diseases respiratory ways).
In bronchial asthma or other chronic obstructive pulmonary diseases that can cause symptoms, it is recommended to prescribe bronchodilator therapy simultaneously. Sometimes patients with asthma may experience increased resistance respiratory ways, that's why maybe required increase doses of beta2 stimulants. C sugar diabetes With big fluctuations indicators of glucose in the blood; symptoms of hypoglycemia (eg, tachycardia, palpitations, or sweating) may be masked.
• strict starvation
• constant desensitizing therapy
Like other beta-blockers, bisoprolol can increase both allergen sensitivity and severity. anaphylactic reactions. Treatment adrenaline not always gives expected therapeutic Effect.
• AV block first degrees
• Prinzmetal's angina
• occlusal disease peripheral arteries (may happen gain complaints, especially in early therapy)
• general anesthesia
side action
Highly rarely
Pain or pain in the body, chest pain, chills, cough, difficulty or difficult breath, ear congestion, fever, headache, loss of voice, congestion nose, pain or soreness around eyes and cheekbones, shortness of breath or difficulty breathing, sneezing, sore throat, congestion or runny nose, chest tightness, unusual tiredness or weakness, wheezing breath.
Rarely
Discomfort in chest, dizziness, dizziness
or fainting slow or irregular heartbeat.
Influence on the ability to management vehicles and mechanisms
In a study involving patients with coronary heart disease, bisoprolol did not impair the ability to drive a car. However, due to individual variations in drug response, the ability to to rule transport means or work with mechanisms. it should take account of, in in particular in the beginning of treatment and when changing the drug, as well as in combination with alcohol.
Interaction With others medicinal agents may be an interaction between bisoprolol and any of next:
Aldesleukin, aliskiren, alpha agonists (eg clonidine, methyldopa), alpha blockers (for example, alfuzosin, doxazosin, tamsulosin), amifostine, amiodarone, amphetamines (for example, dextroamphetamine, lisdexamfetamine) inhibitors angiotensin-converting enzyme (ACE; captopril, enalapril, ramipril), blockers receptors angiotensin (BRA, for example, candesartan, irbesartan , losartan), antimalarials (eg chloroquine, hydroxychloroquine, primaquine), neuroleptics (eg chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone), barbiturates (eg, butalbital, pentobarbital, phenobarbital), beta-2-agonists (eg, salbutamol, formoterol, terbutaline), brimonidine, calcium channel blockers (eg, diltiazem, felodipine, nifedipine , verapamil), carbamazepine.