Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)
NCS HealthCare of KY, Inc dba Vangard Labs
CARVEDILOL
CARVEDILOL 6.25 mg
ORAL
PRESCRIPTION DRUG
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.
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. Blistercards of 30 NDC 0615-7944-39 Unit dose boxes of 30 NDC 0615-7944-30 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. Blistercards of 30 NDC 0615-8018-39 Unit dose boxes of 30 NDC 0615-8018-30 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. Blistercards of 30 NDC 0615-7945-39 Unit dose boxes of 30 NDC 0615-7945-30 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. Blistercards of 30 NDC 0615-7946-39 Unit dose boxes of 30 NDC 0615-7946-30 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 NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- 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 m Pročitajte cijeli dokument