Brand name: SB-Bisop

  Generic name with specification: Bisoprolol Fumarate USP

Strength: 5 mg

Composition: Each film coated  tablet contains Bisoprolol Fumarate USP  5 mg.

INDICATION:

SB-Bisop is indicated in the management of hypertension and in the treatment of angina. It may be used alone or in combination with other antihypertensive agents.

DOSAGE & ADMINISTRATION:

The dose of SB-Bisop must be individualized to the needs of the patient. The usual starting dose is SB-Bisop 5 mg once daily. If the antihypertensive effect of SB-Bisop 5 mg is inadequate, the dose may be increased to SB-Bisop 10 mg and then, if necessary, to 20 mg once daily.

Patients with Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance <40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-tritration. Since limited data suggest that Bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis.

Geriatric Patients: It is not necessary to adjust the dose in the elderly, unless there is also   significant renal or hepatic dysfunction.

Pediatric Patients: There is no pediatric experience with Bisoprolol Fumarate.

Side effects

Fatigue, dizziness, headache, disturbances of the gut such as nausea, vomiting, diarrhea,   constipation or abdominal pain, cold or numb extremities, e.g. hands and feet, muscle weakness or cramps, slower than normal heart beat (bradycardia), worsening of heart failure, sleep disturbance, depression, breathing difficulties due to a narrowing of the airways (bronchospasm) in people with asthma or COPD.

Contraindications

Bisoprolol Fumarate is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.

Pregnancy category:  C

Pregnancy: Bisoprolol Fumarate should not be used during pregnancy unless clearly necessary. If treatment with Bisoprolol Fumarate is considered necessary, the uteroplacental blood flow and the foetal growth should be monitored. In case of harmful effects on pregnancy or the foetus, alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.

Lactation: It is not known whether this drug is excreted in human milk. Therefore, breast-feeding is not recommended during administration of Bisoprolol Fumarate.

Available packaging: 30’S.

Unit Price: 10 tk.