Nebivolol is the generic equivalent of the brand-name drug NEBIVOLOL. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Nebivolol through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )] . Nebivolol tablets may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits hav…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions ( 6.1 ): • Headache, fatigue To report SUSPECTED ADVERSE REACTIONS, Contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Nebivolol has been evaluated for safety in patients with hypertension and in patients with heart failure. The observed adverse reaction profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials…
Drug Interactions
7 DRUG INTERACTIONS • CYP2D6 enzyme inhibitors may increase nebivolol levels. ( 7.1 ) • Reserpine or clonidine may produce excessive reduction of sympathetic activity. ( 7.2 ) • Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. ( 7.3 ) • Verapamil- or diltiazem-type calcium channel blockers may cause excessive reductions in heart rate, blood pressure, and cardiac contractility. ( 7.4 ) 7.1 CYP2…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Can be taken with and without food. Individualize to the needs of the patient and monitor during up-titration. ( 2 ) • Hypertension: Most patients start at 5 mg once daily. Dose can be increased at 2-week intervals up to 40 mg. ( 2.1 ) 2.1 Hypertension The dose of nebivolol tablets must be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other ag…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). • Patient Advice Advise patients to take nebivolol tablets regularly and continuously, as directed. Nebivolol tablets can be taken with or without food. If a dose is missed, take the next scheduled dose only (without doubling it). Do not interrupt or discontinue nebivolol tablets without consulting the physician. Patients should know how they react to this medicine before they operate automobiles, use machinery, or engage in other tasks requiring alertness. Advise patients to consult a physician if any d…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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