CARVEDILOL- carvedilol tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

NuCare Pharmaceuticals, Inc.

INN (mednarodno ime):

CARVEDILOL

Sestava:

CARVEDILOL 6.25 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)] . Carvedilol tablets are contraindicated in the following conditions: - Bronchial asthma or related bronchospastic conditions.

Povzetek izdelek:

Carvedilol Tablets USP, 3.125 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the other side.          Bottles of 100               NDC 65862-142-01          Bottles of 500               NDC 65862-142-05          Bottles of 1,000            NDC 65862-142-99 Carvedilol Tablets USP, 6.25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘02’ on the other side.           Bottles of 100               NDC 65862-143-01          Bottles of 500               NDC 65862-143-05          Bottles of 1,000            NDC 65862-143-99 Carvedilol Tablets USP, 12.5 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘03’ on the other side.          Bottles of 100               NDC 65862-144-01           Bottles of 500               NDC 65862-144-05          Bottles of 1,000            NDC 65862-144-99 Carvedilol Tablets USP, 25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘04’ on the other side.           Bottles of 100               NDC 65862-145-01          Bottles of 500               NDC 65862-145-05          Bottles of 1,000            NDC 65862-145-99 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.  

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
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 is 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 mg,
12.5 mg 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: Do not