Bisoprolol Fumarate belongs to a group of drugs called beta-blockers.
Bisoprolol Fumarate is combined with other medicines to treat stable chronic moderate to severe heart failure.
Bisoprolol Fumarate Tablets may be used to treat the following conditions:
Treatment of high blood pressure (hypertension).
Treatment of coronary heart disease (angina pectoris).
Treatment of stable chronic moderate to severe heart failure with reduced systolic ventricular function (ejection fraction 35%, based on echocardiography) in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.
Bisoprolol Fumarate , 10 mg Tablets is a white to off white round
biconvex tablet with a break line on one side..
How To Use:
The patients should have stable chronic heart failure without acute failure during the past six weeks and a mainly unchanged basic therapy during the past two weeks.
They should be treated at an optimal dose with an ACE inhibitor(or other vasodilators in case of intolerance to ACE inhibitors), a diuretic, and optionally cardiac glycosides, prior to the administration of bisoprolol.
It is recommended that the treating physician should be experienced in the management of chronic heart failure.
Warnings and precautions:
The treatment of stable chronic heart failure with bisoprolol fumarate has to be initiated with a titration phase as given in the description below.
The treatment with bisoprolol fumarate is to be started with a gradual Up titration according to the following steps:
5 mg once daily for a further week, if a well-tolerated increase to
5 mg once daily for the 4 following weeks, if well-tolerated increase to
10 mg once daily for maintenance therapy.
After initiation of treatment with 1.25 mg, the patients should be observed
Over a period of approximately 4 hours (especially as regards blood pressure,
Heart rate, conduction disturbances, signs of worsening of heart failure).
The maximum recommended dose is 10 mg once daily.
Treatment of high blood pressure (hypertension)
Treatment of coronary heart disease (angina pectoris)
Treatment of stable chronic moderate to severe heart failure with reduced systolic ventricular function (ejection fraction ? 35%, based on echocardiography) in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.
Caution & Warnings:
Bisoprolol Fumarate is contraindicated in chronic heart failure patients with:
Acute heart failure or during episodes of heart failure decompensation
Av block of second or third degree
Sick sinus syndrome
Symptomatic bradycardia with less than 60 beats/min before the start of therapy
Symptomatic hypotension (systolic blood pressure less than 100 mm hg)
Severe bronchial asthma or severe chronic obstructive pulmonary disease
Late stages of the peripheral arterial occlusive disease and Raynaud's syndrome
Untreated pheochromocytoma .
Hypersensitivity to bisoprolol or to any of the excipients
The treatment of stable chronic heart failure with bisoprolol has to be initiated
With a special titration phase.
Especially in patients with ischemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to a transitional worsening of a heart condition the initiation and cessation of treatment of stable chronic heart failure with bisoprolol necessitate regular monitoring.
Bisoprolol fumarate must be used with caution in:
Bronchospasm (bronchial asthma, obstructive airways diseases)
Diabetes mellitus with large fluctuations in blood glucose values; symptoms of hypoglycemia can be masked by strict fasting and ongoing desensitization therapy.
As with other beta-blockers, bisoprolol may increase both the sensitivity toward allergens and the severity of anaphylactic reactions. Epinephrine treatment may not always yield the expected therapeutic effect, av block of first-degree prinzmetal's angina
Peripheral arterial occlusive disease (intensification of complaints might happen especially during the start of therapy).
In patients undergoing general anesthesia betablockade reduces the incidence of arrhythmias and myocardial ischemia during induction and intubation and the postoperative period.
It is currently recommended that maintenance betablockade be continued perioperatively.
The anesthetist must be aware of betablockade because of the potential for interactions with other drugs, resulting in bradyarrhythmia, attenuation of the reflex tachycardia and the decreased reflex ability to compensate for blood loss.
If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be done gradually and completed about 48 hours before anesthesia.
There is no therapeutic experience of bisoprolol fumarate treatment of heart
failure in patients with the following diseases and conditions:
NYHA class II heart failure.
Insulin dependent diabetes mellitus (type I).
Impaired renal function (serum creatinine>300 micromole/l).
Impaired liver function.
Patients older than 80 years.
Congenital heart disease.
Hemodynamically significant organic valvular disease.
Myocardial infarction within 3 months.
Combination of bisoprolol fumarate with calcium antagonists of the verapamil And diltiazem type, with Class I antiarrhythmic drugs and centrally acting Antihypertensive drugs is generally not recommended.
In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, bronchodilation therapy should be given concomitantly.
Occasionally an increase in airway resistance may occur in patients with
Asthma, therefore the dose of beta2stimulants may have to be increased.
Bisoprolol Fumarate 10 mg Tablets.