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BYSTOLIC Tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

A-S Medication Solutions

Λέξεις κλειδιά

50090-1307

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1. Indications and Usage

1.1 Hypertension BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure <em>[see Clinical Studies (14.1)]</em>. BYSTOLIC may be used alone or in combination with other antihypertensive ...

2. Dosage and Administration

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 ...

3. Dosage Forms and Strengths

BYSTOLIC is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol. BYSTOLIC tablets are triangular-shaped, biconvex, unscored, ...

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 ...

5. Warnings and Precautions

5.1 Abrupt Cessation of Therapy Do not abruptly discontinue BYSTOLIC therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have ...

6. Adverse Reactions

6.2 Laboratory Abnormalities In controlled monotherapy trials of hypertensive patients, BYSTOLIC was associated with an increase in BUN, uric acid, triglycerides and a decrease in HDL cholesterol and platelet ...

6.1. Clinical Trials Experience

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 ...

6.3. Postmarketing Experience

The following adverse reactions have been identified from spontaneous reports of BYSTOLIC received worldwide and have not been listed elsewhere. These adverse reactions have been chosen for inclusion due ...

7. Drug Interactions

7.1 CYP2D6 Inhibitors Use caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) <em>[see Clinical Pharmacology (12.5)]</em>. 7.2 Hypotensive ...

8. Use in Specific Populations

8.6 Heart Failure In a placebo-controlled trial of 2128 patients (1067 BYSTOLIC, 1061 placebo) over 70 years of age with chronic heart failure receiving a maximum dose of 10 mg per day for a median of ...

8.1. Pregnancy

Risk Summary Available data regarding use of BYSTOLIC in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother ...

8.2. Lactation

Risk Summary There is no information regarding the presence of nebivolol in human milk, the effects on the breastfed infant, or the effects on milk production. Nebivolol is present in rat milk <em>[see ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Pediatric studies in ages newborn to 18 years old have not been conducted because of incomplete characterization of developmental ...

8.5. Geriatric Use

Of the 2800 patients in the U.S. sponsored placebo-controlled clinical hypertension studies, 478 patients were 65 years of age or older. No overall differences in efficacy or in the incidence of adverse ...

10. Overdosage

In clinical trials and worldwide postmarketing experience there were reports of BYSTOLIC overdose. The most common signs and symptoms associated with BYSTOLIC overdosage are bradycardia and hypotension. ...

11. Description

The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1RS)1,1'[(2RS,2SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2'-iminodiethanol hydrochloride. Nebivolol is a ...

12. Clinical Pharmacology

Nebivolol is a β-adrenergic receptor blocking agent. In extensive metabolizers (most of the population) and at doses less than or equal to 10 mg, nebivolol is preferentially β<sub>1</sub> selective. In ...

12.1. Mechanism of Action

The mechanism of action of the antihypertensive response of BYSTOLIC has not been definitively established. Possible factors that may be involved include: (1) decreased heart rate, (2) decreased myocardial ...

12.3. Pharmacokinetics

Nebivolol is metabolized by a number of routes, including glucuronidation and hydroxylation by CYP2D6. The active isomer (d-nebivolol) has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a two-year study of nebivolol in mice, a statistically significant increase in the incidence of testicular Leydig cell hyperplasia and adenomas was observed at 40 mg/kg/day (5 times the maximally recommended ...

14. Clinical Studies

14.1 Hypertension The antihypertensive effectiveness of BYSTOLIC as monotherapy has been demonstrated in three randomized, double-blind, multi-center, placebo-controlled trials at doses ranging from 1.25 ...

16.1. How Supplied

Product: 50090-1307 NDC: 50090-1307-0 30 TABLET in a BOTTLE NDC: 50090-1307-1 90 TABLET in a BOTTLE Distributed by: Allergan USA, Inc., Madison, NJ 07940 Licensed from Mylan Laboratories, Inc.

17. Patient Counseling Information

<em>See FDA-approved patient labeling</em> (Patient Information). <u>Patient Advice:</u> Advise patients to take BYSTOLIC regularly and continuously, as directed. BYSTOLIC can be taken with or without ...
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