SB-Bisop
Generic Name
Bisoprolol Fumarate
Manufacturer
SB Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
sb bisop 5 mg tablet | ৳ 10.00 | N/A |
Description
Overview of the medicine
SB-Bisop contains Bisoprolol Fumarate, a selective beta-1 blocker used to treat high blood pressure, angina pectoris, and stable chronic heart failure. It works by slowing down the heart rate and relaxing blood vessels.
Uses & Indications
Dosage
Adults
For hypertension and angina: Initially 5 mg once daily, adjusted up to 10 mg once daily. For chronic heart failure: Initially 1.25 mg once daily, gradually increased over weeks to a maximum of 10 mg once daily.
Elderly
No dose adjustment generally required, but caution is advised in patients with severe renal or hepatic impairment. Start with the lowest effective dose.
Renal_impairment
For severe renal impairment (creatinine clearance < 20 mL/min), the initial dose is 2.5 mg once daily, maximum 10 mg once daily. For severe hepatic impairment, 2.5 mg once daily, maximum 10 mg once daily.
How to Take
Take orally once daily in the morning, with or without food. Swallow the tablet whole with some liquid; do not chew or crush.
Mechanism of Action
Bisoprolol selectively blocks beta-1 adrenergic receptors, primarily in the heart. This reduces heart rate, myocardial contractility, and oxygen demand, leading to decreased blood pressure and improved cardiac function.
Pharmacokinetics
Onset
Onset of action is within 2-4 hours, with maximal effect seen after 2-4 weeks of consistent dosing.
Excretion
Approximately 50% excreted unchanged by the kidneys, and the remaining 50% as inactive metabolites via hepatic metabolism and renal excretion.
Half life
Elimination half-life is 10-12 hours.
Absorption
Well absorbed from the gastrointestinal tract, with bioavailability of approximately 90%. Peak plasma concentrations are reached within 2-4 hours.
Metabolism
Approximately 50% metabolized in the liver to 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
- Symptomatic bradycardia (< 50 beats/min)
- Symptomatic hypotension
- Severe bronchial asthma or severe chronic obstructive pulmonary disease
- Late stages of peripheral arterial occlusive disease and Raynaud's syndrome
- Metabolic acidosis
Drug Interactions
Clonidine
Risk of rebound hypertension upon clonidine withdrawal if bisoprolol is not tapered slowly.
Insulin and oral antidiabetics
May mask symptoms of hypoglycemia; adjust dosage if necessary.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
May reduce the hypotensive effect of bisoprolol.
Antiarrhythmics (e.g., disopyramide, amiodarone)
Increased risk of cardiac depression and bradycardia.
Calcium channel blockers (e.g., verapamil, diltiazem)
Increased risk of bradycardia, hypotension, and heart block. Avoid concomitant use or monitor closely.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency. Management involves symptomatic and supportive treatment, including gastric lavage, activated charcoal, and intravenous atropine for severe bradycardia.
Pregnancy & Lactation
Pregnancy Category C. Bisoprolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human breast milk; therefore, caution should be exercised when administered to a nursing woman.
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
- Symptomatic bradycardia (< 50 beats/min)
- Symptomatic hypotension
- Severe bronchial asthma or severe chronic obstructive pulmonary disease
- Late stages of peripheral arterial occlusive disease and Raynaud's syndrome
- Metabolic acidosis
Drug Interactions
Clonidine
Risk of rebound hypertension upon clonidine withdrawal if bisoprolol is not tapered slowly.
Insulin and oral antidiabetics
May mask symptoms of hypoglycemia; adjust dosage if necessary.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
May reduce the hypotensive effect of bisoprolol.
Antiarrhythmics (e.g., disopyramide, amiodarone)
Increased risk of cardiac depression and bradycardia.
Calcium channel blockers (e.g., verapamil, diltiazem)
Increased risk of bradycardia, hypotension, and heart block. Avoid concomitant use or monitor closely.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency. Management involves symptomatic and supportive treatment, including gastric lavage, activated charcoal, and intravenous atropine for severe bradycardia.
Pregnancy & Lactation
Pregnancy Category C. Bisoprolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human breast milk; therefore, caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date, check specific packaging.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Bisoprolol has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in hypertension, angina, and chronic heart failure. Key trials include CIBIS-II and MERIT-HF for heart failure.
Lab Monitoring
- Regular monitoring of blood pressure and heart rate. In patients with renal or hepatic impairment, monitor kidney and liver function tests periodically.
Doctor Notes
- Emphasize the importance of gradual withdrawal to prevent rebound effects.
- Caution in patients with obstructive airway diseases, diabetes (may mask hypoglycemia symptoms), and peripheral vascular disease.
- Monitor heart rate and blood pressure regularly.
Patient Guidelines
- Take medicine exactly as prescribed by your doctor.
- Do not stop taking SB-Bisop suddenly, as it may worsen your condition.
- Inform your doctor about all other medications you are taking.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness or fatigue, especially at the start of treatment or when changing doses. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Adopt a healthy lifestyle including a balanced diet and regular exercise.
- Avoid smoking and limit alcohol intake.
- Manage stress effectively.
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