CARVEDILOL PHOSPHATE capsule, extended release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2)

Inapatikana kutoka:

Bryant Ranch Prepack

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Carvedilol phosphate extended-release capsules 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 phosphate extended-release capsules are contraindicated in the following conditions: Risk Summary Available data regarding use of carvedilol phosphate extended-release capsules 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 D

Bidhaa muhtasari:

NDC: 63629-9635-1: 30 EXTENDED RELEASE CAPSULEs in a BOTTLE, PLASTIC NDC: 63629-9635-2: 90 EXTENDED RELEASE CAPSULEs in a BOTTLE, PLASTIC

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CARVEDILOL PHOSPHATE- CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL PHOSPHATE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CARVEDILOL PHOSPHATE EXTENDED-RELEASE CAPSULES.
CARVEDILOL PHOSPHATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Carvedilol phosphate extended-release capsules are an
alpha-/beta-adrenergic blocking agent indicated
for the treatment of:
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DOSAGE AND ADMINISTRATION
Take with food. Do not crush or chew capsules. Individualize dosage
and monitor during up-titration. (2)
•
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DOSAGE FORMS AND STRENGTHS
Capsules: 10mg, 20mg, 40mg and 80 mg (3)
CONTRAINDICATIONS
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•
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WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The safety profile of carvedilol phosphate extended-release capsules
was similar to that observed for
immediate-release carvedilol. Most common adverse events seen with
immediate-release carvedilol (6.1):
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC. AT
1-800-406-7984 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
hypertension (1.3)
Hypertension: Start at 20 mg once daily and increase if needed for
blood pressure control to 40 mg
then 80 mg once daily over intervals of 1 to 2 weeks. (2.3)
Elderly patients (> 65 years of age): When switching from higher doses
of immediate-release
carvedilol to carvedilol phosphate extended-release capsules, a lower
starting dose should be
considered to reduce the risk of hypotension and syncope. (2.5)
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