Bisobet
Generic Name
Bisoprolol Fumarate 5 mg
Manufacturer
ACI Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| bisobet 5 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Bisobet 5 mg Tablet contains Bisoprolol Fumarate, a beta-1 selective adrenergic blocking agent. It is primarily used to treat high blood pressure, angina pectoris, and heart failure by reducing heart rate and blood pressure.
Uses & Indications
Dosage
Adults
Typical starting dose for hypertension/angina is 5 mg once daily, may be increased to 10 mg once daily if needed. For heart failure, start with 1.25 mg once daily, titrate up gradually to a maximum of 10 mg once daily.
Elderly
No special dosage adjustment is generally required unless there is severe renal or hepatic dysfunction.
Renal_impairment
For severe renal impairment (creatinine clearance <20 mL/min), initial dose 2.5 mg once daily, maximum 10 mg once daily. For mild to moderate, no initial adjustment.
How to Take
Take the tablet whole with a glass of water, preferably in the morning with or without food. Do not chew or crush.
Mechanism of Action
Bisoprolol selectively blocks beta-1 adrenergic receptors, primarily in the heart. This leads to a decrease in heart rate, myocardial contractility, and cardiac output, thereby reducing blood pressure and myocardial oxygen demand.
Pharmacokinetics
Onset
Within 2-4 hours, maximal effect within 2-6 weeks of consistent therapy.
Excretion
Approximately 50% excreted unchanged in urine, remaining 50% as inactive metabolites via urine and bile.
Half life
9-12 hours
Absorption
Well absorbed from the GI tract (approx. 90%), high bioavailability (approx. 90%). Peak plasma concentrations occur 2-4 hours after administration.
Metabolism
Approximately 50% metabolized in the liver via CYP3A4 into inactive metabolites.
Side Effects
Contraindications
- Acute heart failure or decompensated heart failure requiring intravenous inotropic therapy
- Cardiogenic shock
- Second or third degree AV block (without a pacemaker)
- Sick sinus syndrome (without a pacemaker)
- Sinoatrial block
- Bradycardia (<60 bpm) before start of treatment
- Severe asthma or severe chronic obstructive pulmonary disease
- Severe peripheral arterial disease or Raynaud's syndrome
- Untreated phaeochromocytoma
- Metabolic acidosis
- Hypersensitivity to Bisoprolol or any of its excipients
Drug Interactions
NSAIDs (e.g., Ibuprofen)
May attenuate the antihypertensive effect.
Insulin and oral antidiabetics
May mask symptoms of hypoglycemia (e.g., tachycardia).
Antiarrhythmics (e.g., Amiodarone)
Increased risk of bradycardia and cardiac depression.
Calcium channel blockers (e.g., Verapamil, Diltiazem)
May lead to profound bradycardia, AV block, and heart failure.
Other antihypertensives (e.g., ACE inhibitors, diuretics)
May enhance hypotensive effect.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency. Management involves gastric lavage, activated charcoal, and symptomatic supportive care. Atropine for severe bradycardia, glucagon for persistent bradycardia/hypotension, bronchodilators for bronchospasm, diuretics/vasodilators for heart failure.
Pregnancy & Lactation
Category C for pregnancy. Use only if potential benefit justifies potential risk to the fetus. Bisoprolol is excreted in breast milk in small amounts; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Acute heart failure or decompensated heart failure requiring intravenous inotropic therapy
- Cardiogenic shock
- Second or third degree AV block (without a pacemaker)
- Sick sinus syndrome (without a pacemaker)
- Sinoatrial block
- Bradycardia (<60 bpm) before start of treatment
- Severe asthma or severe chronic obstructive pulmonary disease
- Severe peripheral arterial disease or Raynaud's syndrome
- Untreated phaeochromocytoma
- Metabolic acidosis
- Hypersensitivity to Bisoprolol or any of its excipients
Drug Interactions
NSAIDs (e.g., Ibuprofen)
May attenuate the antihypertensive effect.
Insulin and oral antidiabetics
May mask symptoms of hypoglycemia (e.g., tachycardia).
Antiarrhythmics (e.g., Amiodarone)
Increased risk of bradycardia and cardiac depression.
Calcium channel blockers (e.g., Verapamil, Diltiazem)
May lead to profound bradycardia, AV block, and heart failure.
Other antihypertensives (e.g., ACE inhibitors, diuretics)
May enhance hypotensive effect.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency. Management involves gastric lavage, activated charcoal, and symptomatic supportive care. Atropine for severe bradycardia, glucagon for persistent bradycardia/hypotension, bronchodilators for bronchospasm, diuretics/vasodilators for heart failure.
Pregnancy & Lactation
Category C for pregnancy. Use only if potential benefit justifies potential risk to the fetus. Bisoprolol is excreted in breast milk in small amounts; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Generic available (Patent expired)
WHO Essential Medicine
YesClinical Trials
Bisoprolol has been extensively studied in various clinical trials, demonstrating efficacy in hypertension, angina, and especially in stable chronic heart failure (e.g., CIBIS trials - Cardiac Insufficiency Bisoprolol Study).
Lab Monitoring
- Blood pressure monitoring
- Heart rate monitoring
- Renal function (creatinine, GFR) in patients with impairment
- Liver function tests (LFTs) if clinical suspicion arises
Doctor Notes
- Careful titration is crucial in heart failure patients.
- Monitor for bradycardia and hypotension, especially at initiation.
- Patients with pulmonary disease require careful assessment.
- Advise patients not to stop abruptly.
Patient Guidelines
- Do not stop taking this medicine abruptly without consulting your doctor.
- Take the medicine at the same time each day.
- Report any unusual side effects to your doctor.
- Avoid driving or operating machinery until you know how this medicine affects you.
Missed Dose Advice
If you miss a dose, 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 the dose is changed. Patients should be advised to exercise caution when driving or operating machinery.
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 limit alcohol consumption.
- Monitor your blood pressure regularly at home if advised.
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Global Brand Names
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