CARVEDILOL tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

State of Florida DOH Central Pharmacy

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.1)]. Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.2)]. 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. Such patients sho

Termék összefoglaló:

Carvedilol Tablets, 3.125 mg are white to off-white, round, biconvex, film-coated tablets debossed with ‘Z’ on one side and ‘1’ on other side. Carvedilol Tablets, 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. Carvedilol Tablets, 12.5 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with ‘ZC41’ on one side and plain on other side. Carvedilol Tablets, 25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with ‘ZC42’ on one side and plain on other side. They are supplied by State of Florida DOH Central Pharmacy as follows: 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CARVEDILOL - CARVEDILOL TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
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.
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Drug Interactions (7) December 2008
Contraindications (4) April 2008
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(1.1)
Hype rte nsion(1.2)
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.(2.1)
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.(2.2)
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 (2.3, 4)
History of serious hypersensitivity reaction (e.g., Stevens-Johnson
syndrome, anaphylactic reaction, angioedema) to
carvedilol, any of the components of 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
occur. Reduce the dose as needed. (5.2, 5.3, 5.4)
Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema):
Avoid β-blockers.