products-page-bottom-left-box

B-Cor

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

B-Cor

Manufacturer

Joswe Medicals, Na'ur Jordan.

Therapeutic Class

Beta-blockers

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: 04-8630): One film coated tablet contains 5 mg Bisoprolol fumarate (2:1).

Pack size: 30's

Tablet (NRN: 04-0725): One film coated tablet contains 10 mg Bisoprolol fumarate (2:1).

Pack size: 30's

bcor 5

Pharmacology

Bisoprolol fumarate is a beta1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range.

Cardioselectivity is not absolute, however, and at higher doses (≥20 mg) Bisoprolol fumarate also inhibits beta2-adrenoceptors, chiefly located in the bronchial and vascular musculature; to retain selectivity it is therefore important to use the lowest effective dose.

Indications

High blood pressure (hypertension); Coronary heart disease (angina pectoris).

Contra-indications

Bisoprolol must not be used in cases of untreated myocardial insufficiency (decompensated heart failure), recent myocardial infarction, shock disturbances of atrioventricular conduction (AV block grades II and III), sick sinus syndrome, disturbed stimulus conduction between the sinoatrial node and atrium (sinoatrial block), extremely slow pulse (bradycardia with less than 50 beats/min) prior to the start of treatment, extremely low blood pressure (hypotension), bronchial asthma and advanced stages of peripheral circulatory disturbances.

In the case of adrenal tumor (phaeochromocytoma), Bisoprolol may only be administered after alpha-blockade.

Bisoprolol should not be used during pregnancy or lactation or by children, as no experience has been made so far in man. Animal experiments have shown no damage to fertility or offspring.

Note: Precaution is warranted in diabetic patients with greatly fluctuating blood glucose values, during prolonged periods of fasting and in patients with acidosis.

Precautions/Warnings

Due to the antihypertensive effect of Bisoprolol the ability to drive or operate machinery may be impaired as a result of reactions to the drug varying from individual to individual. This is particularly the case at the start of treatment and with a change of medication as well as upon interaction with alcohol. Specific investigations have shown, however, that there is no fear of reactivity being directly impaired by Bisoprolol.

If by way of exception, Bisoprolol has been used during pregnancy, therapy should be terminated 72 hours prior to the expected date of birth due to the possibility of bradycardia, hypotension and hypoglycaemia occurring in the neonates. If this is not possible, the neonate should be carefully monitored for 48-72 hours after delivery.

Interactions

Due to the antihypertensive effect of Bisoprolol the ability to drive or operate machinery may be impaired as a result of reactions to the drug varying from individual to individual.

This is particularly the case at the start of treatment and with a change of medication as well as upon interaction with alcohol. Specific investigations have shown, however, that there is no fear of reactivity being directly impaired by Bisoprolol.

If by way of exception, Bisoprolol has been used during pregnancy, therapy should be terminated 72 hours prior to the expected date of birth due to the possibility of bradycardia, hypotension and hypoglycaemia occurring in the neonates. If this is not possible, the neonate should be carefully monitored for 48-72 hours after delivery.

Adverse Effects

Particularly at the start of treatment, tiredness, dizziness, mild headaches, perspiration, sleep disturbances, vivid dreams and depressive moods may occur. In rare cases, gastrointestinal disturbances (diarrhoea, constipation, nausea, abdominal pain) and skin reactions (e.g. erythema, pruritis) may occur.

Occassionally, a marked decrease in blood pressure, slow pulse rate or a disturbance of AV conduction are observed. Treatment can occasionally lead to tingling and a sensation of coldness in the limbs and in rare cases to muscle weakness, muscle cramp and reduced lacrimation ( to be taken into account if contact lenses are worn). An increase in airway resistance (difficulties in breathing in patients tending towards bronchospastic reactions, e.g. with asthmoid bronchitis) may occur in rare cases. In elderly patients concurrently suffering from diabetes, glucose tolerance might be impaired. Signs of low blood glucose levels (e.g. rapid heart rate) may be masked.

Dosage & Administration

According to the doctor's prescription, one film coated tablet of B-Cor 5 or one film coated tablet of B-Cor 10 once daily. In milder forms of the disease as well as at the start of treatment, 1 tablet of B-Cor 5 once daily is sufficient in most cases.

If necessary, this dosage may be increased to 20 mg (2 tablets of B-Cor 10mg once daily) may be necessary only in isolated cases.

The film coated tablets should be swallowed whole with some liquid. It is recommended to take B-Cor in the morning on an empty stomach or with the breakfast.

Dose adjustment is generally not required in patients with hepatic or renal insufficiency of mild or moderate severity. A daily dose of 10 mg Bisoprolol should not be exceeded in patients with terminal renal insufficiency (creatinine clearance

Duration of treatment: Generally, treatment with B-Cor is a long term therapy. The dosage of B-Cor must not be altered without the doctor's directions. Nor should therapy be discontinued without the doctor's directions. Therapy with B-Cor must not be discontinued abruptly but must fundamentally be discontinued on a gradual basis. Particular attention must be paid to this in patients suffering from coronary artery disease.

Overdosage:

In the case of overdosage or a precarious drop in pulse rate and/or blood pressure, treatment with Bisoprolol must be discontinued. If necessary, the following antidotes should be administered alone or consecutively: Atropine intravenous 0.5-2 mg, Orciprenaline slowly IV until it takes effect; also Glucagon may be given at a dose of 1-5 (-10) mg.

Storage/Handling Recommendations

Store below 30ºC. Keep out of the reach of children.

Review Date

2017-09-18 11:42:00