Nebipro 5 mg (Tablet)

Unit Price: ৳ 10.00 (3 x 10: ৳ 300.00)
Strip Price: ৳ 100.00

Medicine Details

Category Details
Generic Nebivolol hydrochloride
Company Incepta pharmaceuticals ltd
Also available as
Nebipro 25 mg tablet

Indications

  • Hypertension
  • Treatment of essential hypertension
  • Chronic heart failure (CHF)
  • Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients

Pharmacology

  • β adrenergic receptor blocking agent
  • Inhibits both β1 and β1 adrenergic receptors
  • Lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations
  • Does not demonstrate β1-adrenergic receptor blockade activity at clinically relevant doses
  • Metabolized by glucuronidation and hydroxylation by CYP2D6
  • Active isomer (d-nebivolol) has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers
  • Exposure to d-nebivolol is substantially increased in poor metabolizers
  • Metabolites contribute to beta-blocking activity
  • Decreased heart rate
  • Decreased myocardial contractility
  • Diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers
  • Suppression of renin activity
  • Vasodilation and decreased peripheral vascular resistance
  • Absorption is similar to an oral solution
  • Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing
  • Food does not alter the pharmacokinetics
  • Plasma protein binding of nebivolol is approximately 98%, mostly to albumin
  • Independent of nebivolol concentrations
  • Predominantly metabolized via direct glucuronidation of parent
  • Metabolized to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6
  • 38% of the dose was recovered in urine and 44% in feces for extensive metabolizers (EMs)
  • 67% in urine and 13% in feces for poor metabolizers
  • No significant changes in the pharmacokinetics of digoxin or warfarin
  • Nebivolol has no significant effects on the anticoagulant activity of warfarin
  • Starting dose should be reduced in patients with moderate hepatic impairment
  • No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients

Dosage & Administration

  • Recommended starting dose is 5 mg once daily
  • With or without food
  • Monotherapy or in combination with other agents
  • Dose can be increased at 2-week intervals up to 40 mg
  • A more frequent dosing regimen is unlikely to be beneficial

Interaction

  • Care when myocardial depressants or inhibitors of AV conduction are used concurrently
  • Should not be combined with other β-blockers
  • Closely monitored in patients receiving catecholamine-depleting drugs
  • Use caution when co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)

Contraindications

  • Severe bradycardia
  • Heart block greater than first degree
  • Cardiogenic shock
  • Decompensated cardiac failure
  • Sick sinus syndrome (unless a permanent pacemaker is in place)
  • Severe hepatic impairment (Child-Pugh >B)
  • Hypersensitive to any component of this product

Side Effects

  • Headache
  • Nausea
  • Bradycardia

Precautions & Warnings

  • Patients with coronary artery disease should be advised against abrupt discontinuation of therapy
  • Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported following the abrupt discontinuation of therapy with β-blockers
  • Patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy
  • When discontinuation of Nebipro is planned, patients should be carefully observed and advised to minimize physical activity
  • Nebipro should be tapered over 1 to 2 weeks when possible
  • In patients who have compensated congestive heart failure, Nebipro should be administered cautiously
  • If heart failure worsens, discontinuation of Nebipro should be considered
  • Nebipro was not studied in patients with angina pectoris or who had a recent Ml
  • Patients with bronchospastic diseases should not receive (3-blockers
  • Patients should be closely monitored when anesthetic agents which depress myocardial function are used
  • β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia
  • Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels
  • β-blockers may mask clinical signs of hyperthyroidism
  • β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease
  • Caution should be exercised in patients treated concomitantly with β-blockers and calcium channel blockers of the verapamil and diltiazem type
  • Nebipro should be used with caution in patients with severe renal impairment because of decreased renal clearance
  • Nebipro has not been studied in patients receiving dialysis
  • Nebipro should be used with caution in patients with moderate hepatic impairment because of decreased metabolism
  • Nebipro is contraindicated in patients with severe hepatic impairment
  • Patients with a history of severe anaphylactic reactions to allergens may be more reactive to repeated challenges

Use in Special Populations

  • Caution in patients with severe renal impairment because of decreased renal clearance
  • Not studied in patients receiving dialysis
  • Caution in patients with moderate hepatic impairment because of decreased metabolism
  • Contraindicated in patients with severe hepatic impairment
  • Patients with a history of severe anaphylactic reactions to allergens may be more reactive to repeated challenges

Therapeutic Class

  • Beta-adrenoceptor blocking drugs
  • Beta-blockers

Storage Conditions

  • Keep below 30°C temperature
  • Away from light & moisture
  • Keep out of the reach of children

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