Country: United States
Language: English
Source: NLM (National Library of Medicine)
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)
Northwind Pharmaceuticals, LLC
CARVEDILOL
CARVEDILOL 6.25 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) and 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 antihyper
Carvedilol Tablets USP, 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-51655-029-52 in bottles of 30 tablets NDC-51655-029-25 in bottles of 60 tablets NDC-51655-029-26 in bottles of 90 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 Northwind Pharmaceuticals, LLC ---------- MEDICATION GUIDE PATIENT INFORMATION CARVEDILOL TABLETS, USP Read the Patient Information that comes with carvedilol tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about carvedilol tablets, ask your doctor or pharmacist. WHAT IS CARVEDILOL? Carvedilol is a prescription medicine that belongs to a group of medicines called "beta-blockers". Carvedilol tablets are used, often with other medicines, for the following conditions: To treat patients with high blood pressure (hypertension) To treat patients who had a heart attack that worsened how well the heart pumps Carvedilol tablets are not approved for use in children under 18 years of age. WHO SHOULD NOT TAKE CARVEDILOL TABLETS? Do not take carvedilol tablet if you: Have severe heart failure and are hospitalized in the intensive care unit or require certain intravenous medications that help support circulation (inotropic medications) Are prone to asthma or other breathing problems Have a slow heartbeat or a heart that skips a beat (irregular heartbeat) Have liver problems Are allergic to any of the ingredients in carvedilol tablets. The active ingredient is carvedilol. See the end of this leaflet for a list of all the ingredients in carvedilol tablets. WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING CARVEDILOL TABLETS? Tell your doctor about all of your medical conditions, including if you: Have asthma or other lung problems (such as bronchitis or emphysema) Have problems with blood flow in your feet and legs (peripheral vascular disease) carvedilol tablets can make some of your symptoms worse. Have diabetes Have thyroid problems Have a condition called pheochromocytoma Have had severe allergic reactions Are pregnant or trying to become pregnant. It is not known if carvedilol tablets are safe for yo Read the complete document
CARVEDILOL- CARVEDILOL TABLET, FILM COATED NORTHWIND PHARMACEUTICALS, LLC ---------- 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 are 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 mg, 6.25 mg, 12.5 mg, 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: D Read the complete document