Bisobet
Generic Name
Bisoprolol Fumarate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| bisobet 25 mg tablet | ৳ 6.00 | ৳ 60.00 |
Description
Overview of the medicine
Bisobet 2.5 mg Tablet contains Bisoprolol Fumarate, a cardioselective beta-1 adrenergic blocking agent used for the treatment of hypertension, angina pectoris, and chronic stable heart failure.
Uses & Indications
Dosage
Adults
For Hypertension/Angina: Initially 5 mg once daily, may be increased to 10 mg or maximum 20 mg once daily. For Chronic Stable Heart Failure: Initially 1.25 mg once daily, titrated gradually up to 10 mg once daily based on patient tolerance.
Elderly
No specific dosage adjustment usually required, but dose titration should be done carefully.
Renal_impairment
In severe renal impairment (creatinine clearance <20 mL/min), maximum dose is 10 mg daily. For patients on dialysis, no specific dose adjustment needed.
How to Take
Take orally, once daily in the morning, with or without food. Swallow the tablet whole with water. Do not chew or crush.
Mechanism of Action
Bisoprolol selectively blocks beta-1 adrenergic receptors in the heart, leading to a reduction in heart rate, myocardial contractility, and cardiac output. This reduces the heart's workload and oxygen demand.
Pharmacokinetics
Onset
Within 2-4 hours, full effect achieved within 2-6 weeks.
Excretion
Approximately 50% excreted unchanged in urine, and the remaining 50% as inactive metabolites via kidneys and to a lesser extent bile.
Half life
10-12 hours.
Absorption
Well absorbed from the gastrointestinal tract (approximately 90%), peak plasma concentrations reached within 2-4 hours.
Metabolism
Approximately 50% metabolized in the liver to inactive metabolites via CYP2D6 pathway.
Side Effects
Contraindications
- Acute heart failure or decompensated heart failure requiring intravenous inotropes
- Cardiogenic shock
- Second or third degree AV block (without a pacemaker)
- Sick sinus syndrome
- Severe bradycardia (<60 bpm)
- Severe asthma or severe chronic obstructive pulmonary disease (COPD)
- Severe peripheral arterial occlusive disease or Raynaud's syndrome
- Metabolic acidosis
- Untreated pheochromocytoma
- Hypersensitivity to Bisoprolol or any component of the formulation
Drug Interactions
Clonidine
Risk of rebound hypertension upon abrupt withdrawal of clonidine if beta-blocker is not tapered.
NSAIDs (e.g., Ibuprofen)
May reduce the hypotensive effect of bisoprolol.
Insulin and Oral Hypoglycemics
Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
Sympathomimetics (e.g., Adrenaline)
May reduce the effect of beta-blockers and cause hypertensive crisis.
Other Beta-blockers (including eye drops)
Additive effects.
Calcium Channel Blockers (Verapamil, Diltiazem)
Increased risk of bradycardia, AV block, and heart failure.
Antiarrhythmics (Class I e.g., Disopyramide, Quinidine; Class III e.g., Amiodarone)
Potentiation of effects on atrial conduction time and induction of negative inotropic effect.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency, and hypoglycemia. Treatment is supportive and symptomatic, including activated charcoal, atropine for bradycardia, glucagon, and vasopressors for hypotension.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Bisoprolol is excreted in breast milk; therefore, it is advisable to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Acute heart failure or decompensated heart failure requiring intravenous inotropes
- Cardiogenic shock
- Second or third degree AV block (without a pacemaker)
- Sick sinus syndrome
- Severe bradycardia (<60 bpm)
- Severe asthma or severe chronic obstructive pulmonary disease (COPD)
- Severe peripheral arterial occlusive disease or Raynaud's syndrome
- Metabolic acidosis
- Untreated pheochromocytoma
- Hypersensitivity to Bisoprolol or any component of the formulation
Drug Interactions
Clonidine
Risk of rebound hypertension upon abrupt withdrawal of clonidine if beta-blocker is not tapered.
NSAIDs (e.g., Ibuprofen)
May reduce the hypotensive effect of bisoprolol.
Insulin and Oral Hypoglycemics
Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
Sympathomimetics (e.g., Adrenaline)
May reduce the effect of beta-blockers and cause hypertensive crisis.
Other Beta-blockers (including eye drops)
Additive effects.
Calcium Channel Blockers (Verapamil, Diltiazem)
Increased risk of bradycardia, AV block, and heart failure.
Antiarrhythmics (Class I e.g., Disopyramide, Quinidine; Class III e.g., Amiodarone)
Potentiation of effects on atrial conduction time and induction of negative inotropic effect.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency, and hypoglycemia. Treatment is supportive and symptomatic, including activated charcoal, atropine for bradycardia, glucagon, and vasopressors for hypotension.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Bisoprolol is excreted in breast milk; therefore, it is advisable to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA, FDA)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Bisoprolol has been extensively studied in various clinical trials for hypertension, angina, and heart failure, demonstrating its efficacy and safety. Key trials include CIBIS-II and MERIT-HF for heart failure.
Lab Monitoring
- Blood pressure
- Heart rate
- Renal function (BUN, Creatinine)
- Liver function tests (periodically)
- Blood glucose (especially in diabetics)
Doctor Notes
- Ensure gradual titration, especially when initiating for heart failure.
- Advise patients not to discontinue abruptly due to risk of rebound effects.
- Monitor for signs of worsening heart failure or bronchospasm, particularly in susceptible patients.
Patient Guidelines
- Take Bisobet regularly as prescribed, do not stop abruptly.
- Monitor your blood pressure and heart rate regularly.
- Inform your doctor about all other medications you are taking.
- Report any unusual side effects to your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Bisoprolol may cause dizziness or fatigue, especially at the start of treatment or when changing doses. Patients should be cautious when driving or operating machinery until they know how they react to the medication.
Lifestyle Advice
- Maintain a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity (as advised by your doctor).
- Avoid smoking and excessive alcohol consumption.
- Manage stress effectively.
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