Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)
H.J. Harkins Company, Inc.
CARVEDILOL
CARVEDILOL 6.25 mg
ORAL
PRESCRIPTION DRUG
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
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 and are supplied as follows: NDC-68382-092-17 in bottles of 28 tablets NDC-68382-092-01 in bottles of 100 tablets NDC-68382-092-05 in bottles of 500 tablets 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 and are supplied as follows: NDC-68382-093-17 in bottles of 28 tablets NDC-68382-093-01 in bottles of 100 tablets NDC-68382-093-05 in bottles of 500 tablets 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 and are supplied as follows: NDC-68382-094-17 in bottles of 28 tablets NDC-68382-094-01 in bottles of 100 tablets NDC-68382-094-05 in bottles of 500 tablets 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 and are supplied as follows: NDC-68382-095-17 in bottles of 28 tablets NDC-68382-095-01 in bottles of 100 tablets NDC-68382-095-05 in bottles of 500 tablets 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.
Abbreviated New Drug Application
CARVEDILOL - CARVEDILOL TABLET, FILM COATED H.J. HARKINS COMPANY, 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. 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. (4) However Perskaitykite visą dokumentą