CARVEDILOL tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)

Disponível em:

NuCare Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

CARVEDILOL

Composição:

CARVEDILOL 3.125 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 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 should first be weaned from intravenous therapy before initiating carvedilol tablets. - Patients with severe hepatic impairment. - Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. Pregnancy Category C. Studies performed in pregnant rats and rabbits given carvedilol revealed increased post-implantation loss in rats at doses of 300 mg per kg per day (50 times the maximum recommended human dose [MRHD] as mg per m 2 ) and in rabbits at doses of 75 mg per kg per day (25 times the MRHD as mg per m 2 ). In the rats, there was also a decrease in fetal body weight at the maternally toxic dose of 300 mg per kg per day (50 times the MRHD as mg per m 2 ), which was accompanied by an elevation in the frequency of fetuses with delayed skeletal development (missing or stunted 13th rib). In rats the no-observed-effect level for developmental toxicity was 60 mg per kg per day (10 times the MRHD as mg per m 2 ); in rabbits it was 15 mg per kg per day (5 times the MRHD as mg per m 2 ). There are no adequate and well-controlled studies in pregnant women. Carvedilol tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Studies in rats have shown that carvedilol and/or its metabolites (as well as other β-blockers) cross the placental barrier and are excreted in breast milk. There was increased mortality at one week post-partum in neonates from rats treated with 60 mg per kg per day (10 times the MRHD as mg per m 2 ) and above during the last trimester through day 22 of lactation. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from β-blockers, especially bradycardia, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The effects of other α- and β-blocking agents have included perinatal and neonatal distress. Effectiveness of carvedilol tablets in patients younger than 18 years has not been established. In a double-blind trial, 161 children (mean age: 6 years, range: 2 months to 17 years; 45% younger than 2 years) with chronic heart failure [NYHA class II-IV, left ventricular ejection fraction less than 40% for children with a systemic left ventricle (LV), and moderate-severe ventricular dysfunction qualitatively by echo for those with a systemic ventricle that was not an LV] who were receiving standard background treatment were randomized to placebo or to 2 dose levels of carvedilol. These dose levels produced placebo-corrected heart rate reduction of 4 to 6 heart beats per minute, indicative of β-blockade activity. Exposure appeared to be lower in pediatric subjects than adults. After 8 months of follow-up, there was no significant effect of treatment on clinical outcomes. Adverse reactions in this trial that occurred in greater than 10% of subjects treated with carvedilol and at twice the rate of placebo-treated subjects included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%). Of the 765 subjects with heart failure randomized to carvedilol in US clinical trials, 31% (235) were aged 65 years or older, and 7.3% (56) were aged 75 years or older. Of the 1,156 subjects randomized to carvedilol in a long-term, placebo-controlled trial in severe heart failure, 47% (547) were aged 65 years or older, and 15% (174) were aged 75 years or older. Of 3,025 subjects receiving carvedilol in heart failure trials worldwide, 42% were aged 65 years or older. Of the 975 myocardial infarction subjects randomized to carvedilol tablets in the CAPRICORN trial, 48% (468) were aged 65 years or older, and 11% (111) were aged 75 years or older.   Of the 2,065 hypertensive subjects in US clinical trials of efficacy or safety who were treated with carvedilol tablets, 21% (436) were aged 65 years or older. Of 3,722 subjects receiving carvedilol tablets in hypertension clinical trials conducted worldwide, 24% were aged 65 years or older. With the exception of dizziness in hypertensive subjects (incidence 8.8% in the elderly versus 6% in younger subjects), no overall differences in the safety or effectiveness (see Figure 2 and 4) were observed between the older subjects and younger subjects in each of these populations. Similarly, other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Resumo do produto:

Carvedilol Tablets USP, 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-68071-3138-3 bottles of 30 NDC-68071-3138-6 bottles of 60 NDC-68071-3138-9 bottles of 90 NDC 68071-3138-8 bottles of 180 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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
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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 carvedilol. ( 4)
WARNINGS AND PRECAUTIONS
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly discontinue. (
5.1)
Bradycardia, hy