CARVEDILOL- carvedilol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cipla USA Inc.

INN (International Name):

CARVEDILOL

Composition:

CARVEDILOL 3.125 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 is contraindicated in the following conditions: - Bronchial asthma or related bronchospastic conditions. Deaths from status

Product summary:

White, capsule-shaped, biconvex, film-coated tablets containing carvedilol: 3.125 mg-debossed with 'C263' on one side and plain on other side, in bottles of 30; in bottles of 100; in bottles of 500;in bottles of 1000;6.25 mg-debossed with 'C264' on one side and plain on other side, in bottles of 30; in bottles of 100; in bottles of 500;in bottles of 1000;12.5 mg-debossed with 'Cipla' on one side and'265' on other side, in bottles of 30; in bottles of 100; in bottles of 500;in bottles of 1000; 25 mg-debossed with 'Cipla' on one side and'266' on other side, in bottles of 30; in bottles of 100; in bottles of 500, in bottles of 1000. 3.125 mg Bottles of 30 NDC   69097-263-02 Bottles of 100 NDC   69097-263-07 Bottles of 500 NDC   69097-263-12 Bottles of 1000 NDC   69097-263-15 6.25 mg Bottles of 30 NDC   69097-264-02 Bottles of 100 NDC   69097-264-07 Bottles of 500 NDC   69097-264-12 Bottles of 1000 NDC   69097-264-15 12.5 mg Bottles of 30 NDC   69097-265-02 Bottles of 100 NDC   69097-265-07 Bottles of 500 NDC   69097-265-12 Bottles of 1000 NDC   69097-265-15 25 mg Bottles of 30 NDC   69097-266-02 Bottles of 100 NDC   69097-266-07 Bottles of 500 NDC   69097-266-12 Bottles of 1000 NDC   69097-266-15 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
CIPLA USA 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 tablets 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,
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, 6.25, 12.5, 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 abruptly discontinue. (5.1)
Bradycardia, hypotensio