CARVEDILOL PHOSPHATE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

INN (International Name):

CARVEDILOL PHOSPHATE

Composition:

CARVEDILOL PHOSPHATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carvedilol Phosphate extended-release capsules 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 Phosphate extended-release capsules 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 Phosphate extended-release capsules are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)] . They 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 a

Product summary:

The hard gelatin capsules are available in the following strengths: Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light‑resistant container.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CARVEDILOL PHOSPHATE- CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE
APOTEX CORP.
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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
C APSULE S.
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: 10 mg, 20 mg, 40 mg, 80 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The safety profile of Carvedilol Phosphate extended-release was
similar to that observed for immediate-release carvedilol.
Most common adverse events seen with immediate-release carvedilol.
(6.1):
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mild to severe chronic heart failure. (1.1)
left ventricular dysfunction following myocardial infarction in
clinically stable patients. (1.2)
hypertension. (1.3)
Heart failure: Start at 10 mg once daily and increase to 20, 40, and
then 80 mg once 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
20 mg once daily and increase to 40 mg then 80
mg once daily after intervals of 3 to 10 days. A lower starting dose
or slower titration may be used. (2.2)
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 tablets to
Carvedilol Phosphate extended-release capsules, a lower starting dose
should