Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)
Cipla USA Inc.
CARVEDILOL
CARVEDILOL 3.125 mg
ORAL
PRESCRIPTION DRUG
Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies (14.1)] . 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 less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)] . Carvedilol tablets 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 is contraindicated in the following conditions: - Bronchial asthma or related bronchospastic conditions. Deaths from status
White, capsule-shaped, biconvex, film-coated tablets containing carvedilol: 3.125 mg-debossed with 'C263' on one side and plain on other side, in bottles of 30; in bottles of 100; in bottles of 500;in bottles of 1000;6.25 mg-debossed with 'C264' on one side and plain on other side, in bottles of 30; in bottles of 100; in bottles of 500;in bottles of 1000;12.5 mg-debossed with 'Cipla' on one side and'265' on other side, in bottles of 30; in bottles of 100; in bottles of 500;in bottles of 1000; 25 mg-debossed with 'Cipla' on one side and'266' on other side, in bottles of 30; in bottles of 100; in bottles of 500, in bottles of 1000. 3.125 mg Bottles of 30 NDC 69097-263-02 Bottles of 100 NDC 69097-263-07 Bottles of 500 NDC 69097-263-12 Bottles of 1000 NDC 69097-263-15 6.25 mg Bottles of 30 NDC 69097-264-02 Bottles of 100 NDC 69097-264-07 Bottles of 500 NDC 69097-264-12 Bottles of 1000 NDC 69097-264-15 12.5 mg Bottles of 30 NDC 69097-265-02 Bottles of 100 NDC 69097-265-07 Bottles of 500 NDC 69097-265-12 Bottles of 1000 NDC 69097-265-15 25 mg Bottles of 30 NDC 69097-266-02 Bottles of 100 NDC 69097-266-07 Bottles of 500 NDC 69097-266-12 Bottles of 1000 NDC 69097-266-15 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 CIPLA USA 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 CARVEDILOL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL:1995 INDICATIONS AND USAGE Carvedilol tablets is an alpha/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure (1.1) 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) Heart failure: Start at 3.125 mg twice daily and increase to 6.25, 12.5, and then 25 mg twice daily over intervals of at least 2 weeks. Maintain lower doses if higher doses are not tolerated. (2.1) 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, 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 (2.4, 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, hypotensio Lestu allt skjalið