CARVEDILOL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc

INN (International Name):

CARVEDILOL

Composition:

CARVEDILOL 6.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) , 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: Risk Summary Available data regarding use of carvedilol in pregna

Product summary:

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 30               NDC 68788-6817-3 Bottles of 60               NDC 68788-6817-6 Bottles of 90               NDC 68788-6817-9 Bottles of 100               NDC 68788-6817-1 Bottles of 120               NDC 68788-6817-8 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 30               NDC68788-6819-3        Bottles of 60               NDC68788-6819-6          Bottles of 90               NDC68788-6819-9         Bottles of 100               NDC68788-6819-1         Bottles of 120               NDC68788-6819-8         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.  

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC
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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 is an alpha-/beta-adrenergic blocking agent indicated for
the treatment of:
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DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration.
(2)
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DOSAGE FORMS AND STRENGTHS
Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse events (6.1):
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AUROBINDO PHARMA USA,
INC. AT 1-866-
mild to severe chronic heart failure (1.1)
left ventricular dysfunction following myocardial infarction in
clinically stable patients (1.2)
hypertension (1.3)
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)
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
syndr