NEBIVOLOL tablet NEBIVOLOL- nebibolol tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

NEBIVOLOL (UNII: 030Y90569U) (NEBIVOLOL - UNII:030Y90569U)

Beschikbaar vanaf:

Solco Healthcare US, LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 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 nebivolol tablets. 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 achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nebivolol tablets are contraindicated in the following conditions: Risk Summary Available data regarding use of nebivolol tablets in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate [see Clinical Considerations]. Oral administration of nebivolol to pregnant rats during organogenesis resulted in embryofetal and perinatal lethality at doses approximately equivalent to the maximum recommended human dose (MRHD). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal adverse reactions Neonates of women with hypertension, who are treated with beta-blockers during the third trimester of pregnancy, may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage accordingly. Data Animal Data Nebivolol was shown to increase embryo-fetal and perinatal lethality in rats at approximately 1.2 times the MRHD or 40 mg/day on a mg/m2 basis. Decreased pup body weights occurred at 1.25 and 2.5 mg/kg in rats, when exposed during the perinatal period (late gestation, parturition and lactation). At 5 mg/kg and higher doses (1.2 times the MRHD), prolonged gestation, dystocia and reduced maternal care were produced with corresponding increases in late fetal deaths and stillbirths and decreased birth weight, live litter size and pup survival. These events occurred only when nebivolol was given during the perinatal period (late gestation, parturition and lactation). Insufficient numbers of pups survived at 5 mg/kg to evaluate the offspring for reproductive performance. In studies in which pregnant rats were given nebivolol during organogenesis, reduced fetal body weights were observed at maternally toxic doses of 20 and 40 mg/kg/day (5 and 10 times the MRHD), and small reversible delays in sternal and thoracic ossification associated with the reduced fetal body weights and a small increase in resorption occurred at 40 mg/kg/day (10 times the MRHD). No adverse effects on embryo-fetal viability, sex, weight or morphology were observed in studies in which nebivolol was given to pregnant rabbits at doses as high as 20 mg/kg/day (10 times the MRHD). 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 [see Data] . Because of the potential for β-blockers to produce serious adverse reactions in nursing infants, especially bradycardia, nebivolol tablets are not recommended during nursing. Data In lactating rats, maximum milk levels of unchanged nebivolol were observed at 4 hours after single and repeat doses of 2.5 mg/kg/day. The daily dose (mg/kg body weight) ingested by a rat pup is 0.3% of the dam dose for unchanged nebivolol. 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 toxicity and possible adverse effects on long-term fertility [see Nonclinical Toxicology (13.1)] . Juvenile Animal Toxicity Data Daily oral doses of nebivolol to juvenile rats from post-natal day 14 to post-natal day 27 showed sudden unexplained death at exposures equal to those in human poor metabolizers given a single dose of 10 mg. No mortality was seen at half the adult human exposure. In surviving rats, cardiomyopathy was seen at exposures greater than or equal to the human exposure. Male rat pups exposed to twice the human exposure showed decreases in total sperm count as well as decreases in the total and percentage of motile sperm. 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 events were observed between older and younger patients. In a placebo-controlled trial of 2128 patients (1067 nebivolol tablets, 1061 placebo) over 70 years of age with chronic heart failure receiving a maximum dose of 10 mg per day for a median of 20 months, no worsening of heart failure was reported with nebivolol compared to placebo. However, if heart failure worsens consider discontinuation of nebivolol tablets.

Product samenvatting:

Nebivolol tablets are available for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol. Nebivolol tablets are triangular-shaped, biconvex, unscored, differentiated by color and are debossed with “S” on one side and the number (671, 672, 673, or 674) on the other side. Nebivolol tablets are supplied in the following strengths and package configurations: Nebivolol Tablets Tablet Strength Package Configuration NDC # Tablet Color 2.5 mg Bottle of 30 with child-resistant closure 43547-524-03 Light Blue Bottle of 90 with child-resistant closure 43547-524-09 Bottle of 500 with child-resistant closure 43547-524-50 5 mg Bottle of 30 with child-resistant closure 43547-525-03 Light Yellow Bottle of 90 with child-resistant closure 43547-525-09 Bottle of 500 43547-525-50 10 mg Bottle of 30 with child-resistant closure 43547-526-03 Pink Bottle of 90 with child-resistant closure 43547-526-09 Bottle of 500 43547-526-50 20 mg Bottle of 30 with child-resistant closure 43547-527-03 Light Blue Bottle of 90 with child-resistant closure 43547-527-09 Bottle of 500 43547-527-50 Store at 20o to 25o C (68o to 77o F); excursions permitted between 15o and 30o C (59o and 86o F) [see USP for Controlled Room Temperature] . Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Solco Healthcare US, LLC
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PATIENT INFORMATION
Dispense with Patient Information available at:
www.solcohealthcare.com/druglabeling/nebivolol-tablets.pdf
Nebivolol Tablets
(ne biv′ oh lol)
Read the Patient Information that comes with nebivolol tablets before
you start taking it and each time you
get a refill. There may be new information. This information does not
take the place of talking with your
doctor about your medical condition or your treatment. If you have any
questions about nebivolol tablets, ask
your doctor or pharmacist.
WHAT ARE NEBIVOLOL TABLETS?
Nebivolol tablets are a kind of prescription medicine called a
“beta-blocker”. Nebivolol tablets treat:
•
High blood pressure (hypertension)
Nebivolol tablets can lower blood pressure when used by itself and
with other medicines.
Nebivolol tablets are not approved for children less than 18 years of
age.
WHO SHOULD NOT TAKE NEBIVOLOL TABLETS?
Do not take nebivolol tablets if you:
•
Have heart failure and are in the ICU or need medicines to keep up
your blood circulation
•
Have a slow heartbeat or your heart skips beats (irregular heartbeat)
•
Have severe liver damage
•
Are allergic to any ingredient in nebivolol tablets. The active
ingredient is nebivolol. See the end of this
leaflet for a list of ingredients.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING NEBIVOLOL TABLETS?
Tell your doctor about all of your medical problems, including if you:
•
Have asthma or other lung problems (such as bronchitis or emphysema)
•
Have problems with blood flow in your feet and legs (peripheral
vascular disease) Nebivolol tablets
can make symptoms of blood flow problems worse.
•
Have diabetes and take medicine to control blood sugar
•
Have thyroid problems
•
Have liver or kidney problems
•
Had allergic reactions to medications or have allergies
•
Have a condition called pheochromocytoma
•
Are pregnant or trying to become pregnant. It is not known if
nebivolol tablets are safe for your unborn
baby. Talk with your doctor about the best wa

Productkenmerken

NEBIVOLOL- NEBIVOLOL TABLET
SOLCO HEALTHCARE US, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEBIVOLOL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEBIVOLOL
TABLETS.
NEBIVOLOL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Warnings and Precautions, Hypoglycemia (5.5) 06/2023
INDICATIONS AND USAGE
Nebivolol 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)
DOSAGE AND ADMINISTRATION
Can be taken with and without food. Individualize to the needs of the
patient and monitor during up-
titration. (2)
•
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5, 5, 10, 20 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
MOST COMMON ADVERSE REACTIONS (6.1):
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US,
LLC AT 1-866-257-
2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
Hypertension: Most patients start at 5 mg once daily. Dose can be
increased at 2-week intervals up to
40 mg. (2.1)
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)
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly
discontinue. (5.1)
Diabetes: May mask symptoms of hypoglycemia and alter glucose levels;
monitor (5.5)
Headache, fatigue
CYP2D6 enzyme inhibitors may increase nebivolol levels. (7.1)
Reserpine or clonidine may produce excessive reduction of