API

Nebivolol (5mg)

Drug classification

Beta-blocker; specifically, a selective beta-1 adrenergic receptor antagonist with vasodilatory properties.

Dosage form

Film-coated oral tablet containing 5 mg of nebivolol.

API strength per dosage

Dose

Nebivolol 5 mg is typically initiated at 5 mg once daily for adults with hypertension or heart failure. Dose adjustments may be needed for elderly patients or those with renal or moderate hepatic impairment; start at 2.5 mg once daily. Safety and efficacy in children have not been established. Use caution in severe hepatic impairment.

Mechanism of action

Nebivolol selectively blocks β1-adrenergic receptors, reducing heart rate and myocardial contractility, thereby lowering blood pressure. It also enhances nitric oxide release from the endothelium, causing vasodilation. The combined effects decrease peripheral vascular resistance and cardiac output, resulting in antihypertensive action.

Indications

Treatment of Hypertension (high blood pressure)Prevention of Heart attackPrevention of Stroke

Side effects

Nausea Headache Fatigue Constipation Diarrhea Dizziness Breathlessness Edema swelling

Pregnancy category

Nebivolol should be used during pregnancy only if clearly needed; limited human data, potential fetal risk based on mechanism and animal studies. Consult physician.

Precautions

Monitor blood pressure, heart rate, signs of bradycardia, heart failure, bronchospasm, blood glucose in diabetics, renal and hepatic function, avoid abrupt withdrawal, caution in asthma, COPD, peripheral vascular disease, and in elderly, assess for drug interactions, use caution in pregnancy and lactation.

Contraindications

Hypersensitivity to nebivolol, severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated heart failure, severe hepatic impairment, sick sinus syndrome, severe hypotension, untreated pheochromocytoma.