NEBIVOLOL tablet NEBIVOLOL- nebibolol tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Solco Healthcare US, LLC

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 guidel

Toote kokkuvõte:

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.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Solco Healthcare US, LLC
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PATIENT INFORMATION
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 takes 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 way to treat high blood
pressure while you are pregnant.
•
Are breastfeeding. It is not known if nebivolol

Toote omadused

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
INDICATIONS AND USAGE
Nebivolol tablets are 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):
•
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
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 2/2022
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: Monitor glucose as β-blockers may mask symptoms of
hypoglycemia. (5.5)
Headache, fatigue
CYP2D6 enzyme inhibitors may increase nebivolol levels. (7.1)
Reserpine or clonidine may produce excessive reduction of sympathetic
activity. (7.2)
Both digitalis glycosid