Drugplain

Bystolic 2.5 mg/1

nebivolol hydrochloride · TABLET · Allergan, Inc.

No Recall History
Plain English

Bystolic is a tablet containing nebivolol hydrochloride at 2.5 mg/1, taken oral. Manufactured by Allergan, Inc..

Key Facts

Brand Name
Bystolic
Generic Name
nebivolol hydrochloride
NDC Code (Product)
0456-1402
Manufacturer
Allergan, Inc.
Strength
2.5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
NDA021742
Marketing Start
01/22/2008

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. INDICATIONS AND USAGE BYSTOLIC 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 BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )]. BYSTOLIC 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 have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BYSTOLIC. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to a…

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 BYSTOLIC 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 agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial. Renal Impairment In patients with severe renal impairment (ClCr less than 30 mL/min) the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients receiving dialysis [see Clinical Pharmacology ( 12.4 ) ]. Hepatic Impairment In patients with moderate hepatic impairment, the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients with severe hepatic impairment and therefore it is not recommended in th…

Contraindications

4. CONTRAINDICATIONS BYSTOLIC is contraindicated in the following conditions: Severe bradycardia Heart block greater than first degree Patients with cardiogenic shock Decompensated cardiac failure Sick sinus syndrome (unless a permanent pacemaker is in place) Patients with severe hepatic impairment (Child-Pugh >B) Patients who are hypersensitive to any component of this product. Severe bradycardia ( 4 ) Heart block greater than first degree ( 4 ) Patients with cardiogenic shock ( 4 ) Decompensated cardiac failure ( 4 ) Sick sinus syndrome (unless a permanent pacemaker is in place) ( 4 ) Patients with severe hepatic impairment (Child-Pugh >B) ( 4 ) Hypersensitive to any component of this product ( 4 )

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 CYP2D6 Inhibitors Use caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )] . 7.2 Hypotensive Agents Do not use BYSTOLIC with other β-blockers. Closely monitor patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, because the added β-blocking action of BYSTOLIC may produce excessive reduction of sympathetic activity. In patients who are receiving BYSTOLIC and clonidine, discontinue BYSTOLIC for several days before the gradual tapering of clonidine. 7.3 Digitalis Glycosides Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. C…

Adverse Reactions

6. ADVERSE REACTIONS Most common adverse reactions ( 6.1 ): Headache, fatigue To report SUSPECTED ADVERSE REACTIONS, Contact AbbVie Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience BYSTOLIC 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. Adverse reactions reported for each of these patient populations are provided below. Excluded are adverse reactions considered too general to be informative and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. The data described below reflect worldwide clinical trial exposure to BYSTOLIC in 6545 patients, including 5038 patients treated for hypertension and the remaining 1507 subjects treated for other cardiovascular diseases. Doses ranged from 0.5 mg to 40 mg. Patients received BYSTOLIC for up to 24 months, with over 1900 patients treated for at least 6 months, and approximately 1300 p…

Frequently Asked Questions

What is Bystolic used for?

Bystolic contains nebivolol hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Bystolic a controlled substance?

Bystolic is not classified as a controlled substance by the DEA.

What is the generic name for Bystolic?

The generic name for Bystolic is nebivolol hydrochloride. There are 10 other brand versions of nebivolol hydrochloride.

What is the NDC code for Bystolic 2.5 mg/1?

The NDC (National Drug Code) for Bystolic 2.5 mg/1 is 0456-1402, listed by Allergan, Inc..

Product NDC

0456-1402

Package NDC

0456-1402-01

Other Nebivolol Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)