Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)
NCS HealthCare of KY, Inc dba Vangard Labs
CARVEDILOL
CARVEDILOL 3.125 mg
ORAL
PRESCRIPTION DRUG
Carvedilol is 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 is indicated for the management of essential hypertension [ see CLINICAL STUDIES (14.2, 14.3)]. 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 asthmaticus have been reported following single doses of carvedilol - 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 should first be weaned fro
Carvedilol tablets are available as follows: 3.125 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 61 on the other side. NDC 0615-6583-39, blisterpacks of 30 tablets NDC 0615-6583-30, boxes of 30 tablets for unit-dose dispensing. 6.25 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 62 on the other side. NDC 0615-6584-39, blisterpacks of 30 tablets NDC 0615-6584-30, unit-dose boxes of 30 tablets 12.5 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 116 on the other side. NDC 0615-6585-39, blisterpacks of 30 tablets NDC 0615-6585-30, boxes of 30 tablets for unit-dose dispensing. 25 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 117 on other side. NDC 0615-6586-39, blisterpacks of 30 tablets NDC 0615-6586-30, boxes of 30 tablets for unit-dose dispensing. Store at 20º-25ºC (68º-77ºF) [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 FILM COATED FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Warnings and Precautions, Major Surgery (5.9) Oct 2010 Warnings and Precautions, Intraoperative Floppy Iris Syndrome (5.14) Jan 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 (1.1) Hypertension (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 a permanent pacemaker is 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 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/flui Läs hela dokumentet