Biprosan

Biprosan

bisoprolol

Manufacturer:

Healthcare Pharma

Distributor:

San Lwin Trading

Marketer:

San Lwin Trading
Full Prescribing Info
Contents
Bisoprolol fumarate.
Description
Biprosan 2.5 mg: Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg.
Biprosan 5 mg: Each film coated tablet contains Bisoprolol Fumarate USP 5 mg.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Bisoprolol blocks the action of the sympathetic nervous system on the heart by blocking the heart's beta-1 adrenergic receptors. Bisoprolol reduces the heart rate & force of contraction of the heart, thus lowers blood pressure.
Pharmacokinetics: Absorption: Rapid and almost complete.
Distribution: Widely; highest concentrations in heart, liver, lungs, and saliva.
Metabolism: Extensively hepatic; significant first-pass effect (-20%).
Excretion: Urine (50% as unchanged drug, remainder as inactive metabolites); feces (<2%).
Indications/Uses
Biprosan (Bisoprolol) is indicated in the management of hypertension and in the treatment of angina and heart failure. It may be used alone or in combination with other antihypertensive agents.
Dosage/Direction for Use
The dose of Biprosan must be individualized to the needs of the patient. The usual starting dose is Biprosan 5 mg once daily. In some patients, Biprosan 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of Biprosan 5 mg is inadequate, the dose may be increased to Biprosan 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-titration. 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.
Overdosage
The most common signs expected with overdosage of a beta-blocker are bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia. Only a few cases of overdose with Bisoprolol have been reported. Bradycardia and/or hypotension were noted. Sympathomimetic agents were given in some cases, and all patients recovered. In general, if overdose occurs, Bisoprolol therapy should be stopped and supportive and symptomatic treatment should be provided.
Contraindications
Bisoprolol is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.
Special Precautions
Impaired renal or hepatic function: Use caution in adjusting the dose of Bisoprolol in patients with renal or hepatic impairment.
Risk of anaphylactic reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Use In Pregnancy & Lactation
Pregnancy: Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with Bisoprolol is considered necessary, the uteroplacental blood flow and the fetal growth should be monitored. In case of harmful effects on pregnancy or the fetus, 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.
Adverse Reactions
Fatigue, dizziness, headache, disturbances of the gut such as nausea, vomiting, diarrhoea, 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.
Storage
Store at temperature not exceeding 30°C in a dry place. Protect from light and moisture.
MIMS Class
ATC Classification
C07AB07 - bisoprolol ; Belongs to the class of selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
Presentation/Packing
FC tab 2.5 mg x 3 x 10's. 5 mg x 3 x 10's.
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