Nebilol Plus
Generic Name
Nebivolol + Hydrochlorothiazide
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nebilol plus 5 mg tablet | ৳ 12.00 | ৳ 168.00 |
Description
Overview of the medicine
Nebilol Plus is a combination medicine used to treat essential hypertension. It contains Nebivolol, a beta-blocker that lowers heart rate and relaxes blood vessels, and Hydrochlorothiazide, a diuretic that increases urine production and removes excess water and salt from the body.
Uses & Indications
Dosage
Adults
Usually one tablet (Nebivolol 5 mg / Hydrochlorothiazide 12.5 mg) once daily. Dosage should be individualized and adjusted based on patient response.
Elderly
No specific dose adjustment is required in elderly patients, but caution should be exercised.
Renal_impairment
Not recommended for patients with severe renal impairment (creatinine clearance < 30 mL/min). For moderate impairment (30-80 mL/min), monitor closely. Not for anuria.
How to Take
Take orally once daily, preferably at the same time each day, with or without food.
Mechanism of Action
Nebivolol is a highly selective beta1-adrenergic receptor blocker that causes vasodilation, possibly through a nitric oxide-dependent mechanism. Hydrochlorothiazide is a thiazide diuretic that acts by inhibiting the sodium-chloride cotransporter in the distal convoluted tubule, thereby increasing the excretion of sodium, chloride, and water.
Pharmacokinetics
Onset
Nebivolol: 1-2 hours for effect; Hydrochlorothiazide: 2 hours for diuretic effect.
Excretion
Nebivolol and its metabolites are excreted via urine (approx. 50%) and feces (approx. 50%). Hydrochlorothiazide is primarily excreted unchanged by the kidneys.
Half life
Nebivolol: Approximately 10-12 hours in extensive metabolizers, 20-30 hours in poor metabolizers. Hydrochlorothiazide: 6-15 hours.
Absorption
Nebivolol is rapidly absorbed after oral administration, bioavailability is about 12% in extensive metabolizers and higher in poor metabolizers. Hydrochlorothiazide is well absorbed after oral administration, with bioavailability ranging from 65-75%.
Metabolism
Nebivolol is extensively metabolized in the liver via CYP2D6 and glucuronidation. Hydrochlorothiazide is not significantly metabolized.
Side Effects
Contraindications
- Hypersensitivity to nebivolol, hydrochlorothiazide, or other sulfonamide-derived drugs
- Severe hepatic impairment
- Severe renal impairment (creatinine clearance < 30 mL/min) or anuria
- Acute heart failure, cardiogenic shock, or episodes of decompensation requiring intravenous inotropic therapy
- Sick sinus syndrome, including sino-atrial block
- Second and third-degree atrioventricular block (without a pacemaker)
- Severe bradycardia (< 60 bpm)
- Uncontrolled asthma, severe chronic obstructive pulmonary disease
- Peripheral arterial occlusive disease
- Metabolic acidosis
Drug Interactions
Lithium
Thiazides reduce renal clearance of lithium, increasing risk of lithium toxicity.
Corticosteroids
May increase the risk of hypokalemia when co-administered with hydrochlorothiazide.
Digitalis glycosides (e.g., Digoxin)
Thiazide-induced hypokalemia may enhance the arrhythmogenic effects of digitalis.
Insulin and oral antidiabetic agents
Beta-blockers may mask symptoms of hypoglycemia; thiazides can increase blood glucose levels, requiring adjustment of antidiabetic medication.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of nebivolol and hydrochlorothiazide.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine)
May increase nebivolol plasma levels, leading to increased risk of bradycardia and other adverse effects.
Other antihypertensives (e.g., ACE inhibitors, ARBs, calcium channel blockers)
May potentiate the antihypertensive effects, increasing risk of hypotension.
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 may include severe bradycardia, hypotension, acute heart failure, bronchospasm, and electrolyte disturbances (e.g., hypokalemia). Management is symptomatic and supportive, including IV fluids, vasopressors, atropine for bradycardia, diuretics for fluid overload, and bronchodilators for bronchospasm.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless clearly necessary, as it may cause fetal harm (e.g., bradycardia, intrauterine growth restriction). Thiazides cross the placental barrier and may cause fetal or neonatal jaundice, thrombocytopenia, and other possible adverse reactions. Excreted in breast milk, use during lactation is not recommended.
Side Effects
Contraindications
- Hypersensitivity to nebivolol, hydrochlorothiazide, or other sulfonamide-derived drugs
- Severe hepatic impairment
- Severe renal impairment (creatinine clearance < 30 mL/min) or anuria
- Acute heart failure, cardiogenic shock, or episodes of decompensation requiring intravenous inotropic therapy
- Sick sinus syndrome, including sino-atrial block
- Second and third-degree atrioventricular block (without a pacemaker)
- Severe bradycardia (< 60 bpm)
- Uncontrolled asthma, severe chronic obstructive pulmonary disease
- Peripheral arterial occlusive disease
- Metabolic acidosis
Drug Interactions
Lithium
Thiazides reduce renal clearance of lithium, increasing risk of lithium toxicity.
Corticosteroids
May increase the risk of hypokalemia when co-administered with hydrochlorothiazide.
Digitalis glycosides (e.g., Digoxin)
Thiazide-induced hypokalemia may enhance the arrhythmogenic effects of digitalis.
Insulin and oral antidiabetic agents
Beta-blockers may mask symptoms of hypoglycemia; thiazides can increase blood glucose levels, requiring adjustment of antidiabetic medication.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of nebivolol and hydrochlorothiazide.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine)
May increase nebivolol plasma levels, leading to increased risk of bradycardia and other adverse effects.
Other antihypertensives (e.g., ACE inhibitors, ARBs, calcium channel blockers)
May potentiate the antihypertensive effects, increasing risk of hypotension.
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 may include severe bradycardia, hypotension, acute heart failure, bronchospasm, and electrolyte disturbances (e.g., hypokalemia). Management is symptomatic and supportive, including IV fluids, vasopressors, atropine for bradycardia, diuretics for fluid overload, and bronchodilators for bronchospasm.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless clearly necessary, as it may cause fetal harm (e.g., bradycardia, intrauterine growth restriction). Thiazides cross the placental barrier and may cause fetal or neonatal jaundice, thrombocytopenia, and other possible adverse reactions. Excreted in breast milk, use during lactation is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved (in various countries)
Patent Status
Patent expired for active ingredients, generics available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Nebivolol and Hydrochlorothiazide in treating hypertension, both as monotherapy and in combination.
Lab Monitoring
- Blood pressure
- Heart rate
- Serum electrolytes (potassium, sodium)
- Renal function (creatinine, BUN)
- Blood glucose
- Liver function tests
- Lipid profile (periodically)
Doctor Notes
- Advise patients not to discontinue abruptly due to risk of rebound angina/MI.
- Monitor serum electrolytes, renal function, and glucose levels regularly.
- Caution in patients with diabetes, asthma, or peripheral vascular disease.
- Consider lower initial dose in elderly or renally impaired patients (if creatinine clearance >30 mL/min).
Patient Guidelines
- Take the medicine regularly as prescribed by your doctor.
- Do not stop taking this medicine abruptly without consulting your doctor.
- Monitor your blood pressure regularly at home.
- Inform your doctor about any new or worsening symptoms, especially chest pain or breathing difficulties.
- Avoid driving or operating machinery if you experience dizziness or lightheadedness.
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
This medicine may cause dizziness or fatigue, especially at the start of treatment or when changing dosage. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Follow a low-sodium diet and limit saturated and trans fats.
- Engage in regular physical activity as advised by your doctor.
- Maintain a healthy weight.
- Quit smoking and limit alcohol consumption.
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