Nytenso
Generic Name
Nebivolol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nytenso 5 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Nytenso 5 mg Tablet contains Nebivolol, a selective beta-1 adrenergic blocker with vasodilating properties, primarily used to treat essential hypertension and stable mild to moderate chronic heart failure.
Uses & Indications
Dosage
Adults
For hypertension: Initially 5 mg once daily. Dose may be increased after 1-2 weeks if necessary. For chronic heart failure: Initial dose is 1.25 mg once daily, doubled at 1-2 week intervals to a maximum of 10 mg once daily.
Elderly
For heart failure in patients ≥70 years, initial dose is 1.25 mg once daily, gradually titrated. For hypertension, no specific dose adjustment, but caution is advised.
Renal_impairment
For severe renal impairment (CrCl < 30 mL/min), initial dose is 2.5 mg once daily. Titrate carefully. Not recommended for decompensated heart failure.
How to Take
Take the tablet orally with a glass of water, with or without food, preferably at the same time each day. Do not crush or chew the tablet.
Mechanism of Action
Nebivolol selectively blocks beta-1 adrenergic receptors, reducing heart rate and myocardial contractility. It also causes vasodilation through nitric oxide release from the endothelium, leading to a reduction in peripheral vascular resistance and blood pressure.
Pharmacokinetics
Onset
Antihypertensive effect usually seen within 1-2 hours; maximal effect within 2-4 weeks.
Excretion
Approximately 38% excreted in urine and 48% in feces over 24 days, mainly as metabolites.
Half life
Mean elimination half-life is approximately 10-12 hours for nebivolol in extensive metabolizers; up to 24-30 hours for active hydroxymetabolites in poor metabolizers.
Absorption
Rapidly absorbed after oral administration; bioavailability is variable (12-96%) due to extensive first-pass metabolism, depending on CYP2D6 metabolizer status.
Metabolism
Extensively metabolized in the liver via direct glucuronidation and hydroxylation (primarily by CYP2D6) to active and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to nebivolol or any excipients.
- Liver impairment or failure.
- 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).
- Bronchospasm and bronchial asthma.
- Untreated pheochromocytoma.
- Metabolic acidosis.
- Severe peripheral arterial circulatory disorders.
Drug Interactions
Digitalis glycosides
Increased AV conduction time, risk of bradycardia.
Calcium channel blockers (e.g., verapamil, diltiazem)
Increased risk of AV conduction disturbances and heart failure. Avoid concomitant intravenous use.
Class I antiarrhythmics (e.g., quinidine, propafenone)
Increased risk of depression of myocardial contractility and AV conduction.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine)
May increase nebivolol plasma concentrations, potentially enhancing its effects and side effects.
Other antihypertensives (e.g., ACE inhibitors, diuretics, other beta-blockers)
Additive hypotensive effect, increased risk of bradycardia and hypotension.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency. Treatment is symptomatic and supportive, including atropine for bradycardia, vasopressors for hypotension, and bronchodilators for bronchospasm.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding due to excretion in breast milk.
Side Effects
Contraindications
- Hypersensitivity to nebivolol or any excipients.
- Liver impairment or failure.
- 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).
- Bronchospasm and bronchial asthma.
- Untreated pheochromocytoma.
- Metabolic acidosis.
- Severe peripheral arterial circulatory disorders.
Drug Interactions
Digitalis glycosides
Increased AV conduction time, risk of bradycardia.
Calcium channel blockers (e.g., verapamil, diltiazem)
Increased risk of AV conduction disturbances and heart failure. Avoid concomitant intravenous use.
Class I antiarrhythmics (e.g., quinidine, propafenone)
Increased risk of depression of myocardial contractility and AV conduction.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine)
May increase nebivolol plasma concentrations, potentially enhancing its effects and side effects.
Other antihypertensives (e.g., ACE inhibitors, diuretics, other beta-blockers)
Additive hypotensive effect, increased risk of bradycardia and hypotension.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency. Treatment is symptomatic and supportive, including atropine for bradycardia, vasopressors for hypotension, and bronchodilators for bronchospasm.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding due to excretion in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date
Availability
Available in pharmacies nationwide
Approval Status
Approved
Patent Status
Patent expired, generic versions available
Clinical Trials
Key trials for Nebivolol include the SENIORS trial, which demonstrated its efficacy in elderly patients with chronic heart failure, showing a reduction in the combined endpoint of all-cause mortality or cardiovascular hospitalization.
Lab Monitoring
- Regular monitoring of blood pressure and heart rate.
- Renal function tests (e.g., serum creatinine, BUN) in patients with renal impairment.
- Liver function tests (e.g., ALT, AST) in patients with hepatic impairment.
Doctor Notes
- Nebivolol is unique among beta-blockers due to its nitric oxide-mediated vasodilating effect.
- Careful titration is crucial, especially in elderly patients and those with heart failure.
- Monitor for signs of worsening heart failure or bradycardia.
Patient Guidelines
- Take Nytenso exactly as prescribed by your doctor, do not stop abruptly.
- Report any new or worsening symptoms, especially chest pain or shortness of breath.
- Avoid standing up too quickly from a sitting or lying position to prevent dizziness.
- Inform your doctor or dentist that you are taking this medication before any surgery or dental procedure.
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 double the dose.
Driving Precautions
May cause dizziness or fatigue, especially at the start of treatment or after dose increase. Exercise caution when driving or operating machinery.
Lifestyle Advice
- Adopt a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity as advised by your doctor.
- Maintain a healthy weight.
- Limit alcohol intake and stop smoking.
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