CARVEDILOL tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)

Tilgjengelig fra:

Northwind Pharmaceuticals, LLC

INN (International Name):

CARVEDILOL

Sammensetning:

CARVEDILOL 6.25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [ see Drug Interactions ( 7.4) and Clinical Studies ( 14.1) ]. Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [ see   Clinical Studies ( 14.2) ]. Carvedilol tablets are indicated for the management of essential hypertension [ see   Clinical Studies ( 14.3, 14.4)] . It can be used alone or in combination with other antihyper

Produkt oppsummering:

Carvedilol Tablets USP, 6.25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC40' on one side and plain on other side and are supplied as follows: NDC-51655-029-52 in bottles of 30 tablets NDC-51655-029-25 in bottles of 60 tablets NDC-51655-029-26 in bottles of 90 tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
Northwind Pharmaceuticals, LLC
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MEDICATION GUIDE
PATIENT INFORMATION
CARVEDILOL TABLETS, USP
Read the Patient Information that comes with carvedilol 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 carvedilol
tablets, ask your doctor or pharmacist.
WHAT IS CARVEDILOL?
Carvedilol is a prescription medicine that belongs to a group of
medicines called "beta-blockers".
Carvedilol tablets are used, often with other medicines, for the
following conditions:
To treat patients with high blood pressure (hypertension)
To treat patients who had a heart attack that worsened how well the
heart pumps
Carvedilol tablets are not approved for use in children under 18 years
of age.
WHO SHOULD NOT TAKE CARVEDILOL TABLETS?
Do not take carvedilol tablet if you:
Have severe heart failure and are hospitalized in the intensive care
unit or require certain intravenous
medications that help support circulation (inotropic medications)
Are prone to asthma or other breathing problems
Have a slow heartbeat or a heart that skips a beat (irregular
heartbeat)
Have liver problems
Are allergic to any of the ingredients in carvedilol tablets. The
active ingredient is carvedilol. See the end
of this leaflet for a list of all the ingredients in carvedilol
tablets.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING CARVEDILOL TABLETS?
Tell your doctor about all of your medical conditions, 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) carvedilol tablets can
make some of your symptoms worse.
Have diabetes
Have thyroid problems
Have a condition called pheochromocytoma
Have had severe allergic reactions
Are pregnant or trying to become pregnant. It is not known if
carvedilol tablets are safe for yo

Preparatomtale

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
NORTHWIND PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CARVEDILOL TABLETS.
CARVEDILOL TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Carvedilol tablets are an alpha/beta-adrenergic blocking agent
indicated for the treatment of:
mild to severe chronic heart failure ( 1.1)
left ventricular dysfunction following myocardial infarction in
clinically stable patients( 1.2)
hypertension( 1.3)
DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration.
( 2)
Heart failure: Start at 3.125 mg twice daily and increase to 6.25,
12.5, and then 25 mg twice daily over
intervals of at least 2 weeks. Maintain lower doses if higher doses
are not tolerated. ( 2.1)
Left ventricular dysfunction following myocardial infarction: Start at
6.25 mg twice daily and increase to
12.5 mg then 25 mg twice daily after intervals of 3 to 10 days. A
lower starting dose or slower titration
may be used.( 2.2)
Hypertension: Start at 6.25 mg twice daily and increase if needed for
blood pressure control to 12.5 mg
then 25 mg twice daily over intervals of 1 to 2 weeks.( 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg ( 3)
CONTRAINDICATIONS
Bronchial asthma or related bronchospastic conditions. ( 4)
Second- or third-degree AV block. ( 4)
Sick sinus syndrome. ( 4)
Severe bradycardia (unless permanent pacemaker in place). ( 4)
Patients in cardiogenic shock or decompensated heart failure requiring
the use of IV inotropic therapy. (
4)
Severe hepatic impairment ( 2.4, 4)
History of serious hypersensitivity reaction (e.g., Stevens-Johnson
syndrome, anaphylactic reaction,
angioedema) to any component of this medication or other medications
containing carvedilol. ( 4)
WARNINGS AND PRECAUTIONS
Acute exacerbation of coronary artery disease upon cessation of
therapy: D