CARVEDILOL tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Bayshore Pharmaceuticals LLC

INN (الاسم الدولي):

CARVEDILOL

تركيب:

CARVEDILOL 3.125 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Carvedilol Tablets is 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 Clinical Studies (14.1)]. Carvedilol Tablet 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 less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2) ]. Carvedilol Tablet is 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 Tablet is contraindicated in the following conditions: - Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of Carvedilol Tablet. - 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 Tablet. - 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. Risk Summary Available data regarding use of carvedilol in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and Respiratory depression in the neonate [see Clinical Considerations]. In animal reproduction studies, there was no evidence of adverse developmental outcomes at clinically relevant doses [see Data]. Oral administration of carvedilol to pregnant rats during organogenesis resulted in post-implantation loss, decreased fetal body weight, and an increased frequency of delayed fetal skeletal development at maternally toxic doses that were 50 times the maximum recommended human dose (MRHD). In addition, oral administration of carvedilol to pregnant rabbits during organogenesis resulted in increased post-implantation loss at doses 25 times the MRHD [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions: Neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly. Data Animal Data: Studies performed in rats and rabbits given carvedilol during fetal organogenesis revealed increased post-implantation loss in rats at a maternally toxic dose of 300 mg per kg per day (50 times the MRHD as mg per m2) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg per kg per day (25 times the MRHD as mg per m2). In the rats, there was also a decrease in fetal body weight at 300 mg per kg per day (50 times the MRHD as mg per m’) accompanied by an increased incidence of fetuses with delayed skeletal development. In rats, the no-effect level for embryo-fetal toxicity was 60 mg per kg per day (10 times the MRHD as mg per m2; in rabbits, it was 15 mg per kg per day (5 times the MRHD as mg per m2). In a pre-and post-natal development study in rats administered carvedilol from late gestation through lactation, increased embryo-lethality was observed at a maternally toxic dose of 200 mg per kg per day (approximately 32 times the MRHD as mg per m2), and pup mortality and delays in physical growth/development were observed at 60 mg per kg per day (10 times the MRHD as mg per m2) in the absence of maternal toxicity. The no-effect level was 12 mg per kg per day (2 times the MRHD as mg per m2). Carvedilol was present in fetal rat tissue. Risk Summary There are no data on the presence of carvedilol in human milk, the effects on the breastfed infant, or the effects on milk production. Carvedilol is present in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for carvedilol and any potential adverse effects on the breastfed infant from carvedilol or from the underlying maternal condition. Effectiveness of Carvedilol Tablets in patients younger than 18 years of age has not been established. In a double-blind trial, 161 children (mean age 6 years, range 2 months to 17 years; 45% less than 2 years old) with chronic heart failure [NYHA class II to 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 two dose levels of Carvedilol Tablet. These dose levels produced placebo-corrected heart rate reduction of 4 to 6 heartbeats 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 patients treated with Carvedilol Tablet and at twice the rate of placebo-treated patients 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 Tablets in US clinical trials, 31% (235) were 65 years of age or older, and 7.3% (56) were 75 years of age or older. Of the 1,156 subjects randomized to Carvedilol Tablets in a long-term, placebo-controlled trial in severe heart failure, 47% (547) were 65 years of age or older, and 15% (174) were 75 years of age or older. Of 3,025 subjects receiving Carvedilol Tablets in heart failure trials worldwide, 42% were 65 years of age or older. Of the 975 myocardial infarction patients randomized to Carvedilol Tablet in the CAPRICORN trial, 48% (468) were 65 years of age or older, and 11% (111) were 75 years of age or older. Of the 2,065 hypertensive patients in U.S. clinical trials of efficacy or safety who were treated with Carvedilol Tablet, 21% (436) were 65 years of age or older. Of 3,722 patients receiving Carvedilol Tablet in hypertension clinical trials conducted worldwide, 24% were 65 years of age or older. With the exception of dizziness in hypertensive patients (incidence 8.8% in the elderly versus 6% in younger patients), 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.

ملخص المنتج:

Carvedilol Tablets are available as follows: 3.125 mg- White, oval shaped, film-coated tablet engraved with 254 on one side and plain on the other side contains 3.125 mg of Carvedilol. Tablets are supplied as follows: NDC 76385-110-01 in bottles of 100 tablets NDC 76385-110-50 in bottles of 500 tablets 6.25 mg- White, oval shaped, film-coated tablet engraved with 255 on one side and plain on the other side contains 6.25 mg of Carvedilol. Tablets are supplied as follows: NDC 76385-111-01 in bottles of 100 tablets NDC 76385-111-50 in bottles of 500 tablets 12.5 mg- White, oval shaped, film-coated tablet engraved with 256 on one side and plain on the other side, and contains 12.5 mg of Carvedilol. Tablets are supplied as follows: NDC 76385-112-01 in bottles of 100 tablets NDC 76385-112-50 in bottles of 500 tablets 25 mg- White, oval shaped, film-coated tablet engraved with 257 on one side and plain on the other side contains 25 mg of Carvedilol. Tablets are supplied as follows: NDC 76385-113-01 in bottles of 100 bottles NDC 76385-113-50 in bottles of 500 tablets Store at 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
BAYSHORE PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CARVEDILOL TABLETS, USP, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Carvedilol Tablet 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.