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:

State of Florida DOH Central Pharmacy

INN (International Name):

CARVEDILOL

Composition:

CARVEDILOL 3.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carvedilol tablets, USP 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 ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)] . Carvedilol tablets, USP 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. Deaths from status asthmaticus have been reported following single doses of carvedilol tablets. - Second- or third-degree AV block - Sick sinus syndrome - Severe bradycardia (unless a permanent pacemaker is in place) - Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy.

Product summary:

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. 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.  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. 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.    They are supplied by State of Florida DOH Central Pharmacy as follows: 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
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CARVEDILOL TABLETS, USP.
CARVEDILOL TABLETS, USP
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Major Surgery (5.9) October 2010
Warnings and Precautions, Intraoperative Floppy Iris Syndrome (5.14)
January 2011
INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for
the treatment of:
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)
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, or 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, hypotension, worsening heart failure/fluid retention may
o