Nebinor
Generic Name
Nebivolol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nebinor 5 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Nebivolol is a cardioselective beta-blocker primarily used to treat essential hypertension and stable mild to moderate chronic heart failure in elderly patients.
Uses & Indications
Dosage
Adults
Hypertension: Initially 5 mg once daily. May be increased to 10 mg after 1-2 weeks if necessary. Max 20 mg once daily. Heart failure: Initially 1.25 mg once daily, gradually titrate up to 10 mg once daily based on tolerability.
Elderly
No specific dose adjustment for hypertension; for heart failure, follow standard titration regimen.
Renal_impairment
Initial dose 2.5 mg once daily; may be increased with caution to 5 mg once daily if necessary. Not recommended in severe renal impairment (CrCl < 30 mL/min).
Hepatic_impairment
Initial dose 2.5 mg once daily; use with caution. Not recommended in severe hepatic impairment.
How to Take
Oral administration, preferably at the same time each day, with or without food. Do not chew or crush the tablet.
Mechanism of Action
Nebivolol is a highly selective beta-1 adrenergic receptor blocker. It also causes vasodilation through an endothelium-derived nitric oxide mechanism, leading to reduced peripheral vascular resistance and improved cardiac output.
Pharmacokinetics
Onset
Within 1-2 hours for acute effects; full antihypertensive effect may take 1-2 weeks.
Excretion
Approximately 38% excreted in urine and 48% in feces, mainly as metabolites.
Half life
Approximately 10-12 hours for the parent drug and 24-30 hours for active hydroxymetabolites.
Absorption
Rapidly absorbed after oral administration. Bioavailability is variable due to first-pass metabolism, averaging about 12% in extensive metabolizers and 96% in poor metabolizers.
Metabolism
Extensively metabolized in the liver, primarily via CYP2D6, into active hydroxyl metabolites.
Side Effects
Contraindications
- Acute heart failure, cardiogenic shock, or episodes of decompensation requiring intravenous inotropic therapy
- Sick sinus syndrome, including sino-atrial block
- Second- and third-degree heart block (without a pacemaker)
- Severe bradycardia (heart rate < 60 bpm before starting treatment)
- Severe hepatic impairment
- Bronchial asthma or history of bronchospasm
- Severe chronic obstructive pulmonary disease (COPD)
- Untreated pheochromocytoma
- Metabolic acidosis
- Hypersensitivity to nebivolol or any of its excipients
Drug Interactions
NSAIDs (e.g., ibuprofen, indomethacin)
May reduce the antihypertensive effect of nebivolol.
Calcium channel blockers (e.g., verapamil, diltiazem)
May potentiate negative inotropic and chronotropic effects. IV verapamil is contraindicated.
Class I antiarrhythmics (e.g., quinidine, disopyramide, flecainide)
May potentiate the negative inotropic effect and prolong atrioventricular conduction time.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, thioridazine, quinidine)
May increase nebivolol plasma levels and increase risk of adverse effects.
Antihypertensive drugs, nitrates, tricyclic antidepressants, barbiturates, phenothiazines
Increased hypotensive effects.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include bradycardia, hypotension, bronchospasm, and acute cardiac insufficiency. Management involves symptomatic and supportive treatment: atropine for bradycardia, IV fluids/vasopressors for hypotension, and bronchodilators for bronchospasm.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless clearly necessary, as it may cause fetal bradycardia and hypoglycemia. Nebivolol is excreted in breast milk, so breast-feeding is not recommended.
Side Effects
Contraindications
- Acute heart failure, cardiogenic shock, or episodes of decompensation requiring intravenous inotropic therapy
- Sick sinus syndrome, including sino-atrial block
- Second- and third-degree heart block (without a pacemaker)
- Severe bradycardia (heart rate < 60 bpm before starting treatment)
- Severe hepatic impairment
- Bronchial asthma or history of bronchospasm
- Severe chronic obstructive pulmonary disease (COPD)
- Untreated pheochromocytoma
- Metabolic acidosis
- Hypersensitivity to nebivolol or any of its excipients
Drug Interactions
NSAIDs (e.g., ibuprofen, indomethacin)
May reduce the antihypertensive effect of nebivolol.
Calcium channel blockers (e.g., verapamil, diltiazem)
May potentiate negative inotropic and chronotropic effects. IV verapamil is contraindicated.
Class I antiarrhythmics (e.g., quinidine, disopyramide, flecainide)
May potentiate the negative inotropic effect and prolong atrioventricular conduction time.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, thioridazine, quinidine)
May increase nebivolol plasma levels and increase risk of adverse effects.
Antihypertensive drugs, nitrates, tricyclic antidepressants, barbiturates, phenothiazines
Increased hypotensive effects.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include bradycardia, hypotension, bronchospasm, and acute cardiac insufficiency. Management involves symptomatic and supportive treatment: atropine for bradycardia, IV fluids/vasopressors for hypotension, and bronchodilators for bronchospasm.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless clearly necessary, as it may cause fetal bradycardia and hypoglycemia. Nebivolol is excreted in breast milk, so breast-feeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities for hypertension and heart failure
Patent Status
Off-patent (generic available)
Clinical Trials
Nebivolol has been studied in numerous clinical trials for hypertension (e.g., SENIORS trial for heart failure) demonstrating its efficacy and tolerability.
Lab Monitoring
- Blood pressure
- Heart rate
- Renal function tests (e.g., serum creatinine, BUN)
- Liver function tests (e.g., ALT, AST)
Doctor Notes
- Advise gradual withdrawal over 1-2 weeks.
- Monitor heart rate and blood pressure regularly, especially in patients with co-morbidities like heart failure or renal impairment.
- Caution in patients with obstructive airway disease, diabetes, peripheral arterial disease, or thyroid disorders.
Patient Guidelines
- Take Nebivolol exactly as prescribed by your doctor.
- Do not stop taking this medication abruptly, as it may worsen your condition. Consult your doctor for gradual dose reduction.
- Report any unusual side effects, especially slow heart rate, dizziness, or shortness of breath, to your doctor.
- Monitor your blood pressure and heart rate regularly as advised by 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 continue with your regular schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Nebivolol may cause dizziness or fatigue, especially at the beginning of treatment or when the dose is increased. Patients should be warned about driving or operating machinery until they know how the medicine affects them.
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.
- Manage stress through relaxation techniques.
- Monitor weight regularly.
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