CARVEDILOL tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Direct_Rx

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

1.1 Heart Failure 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), Clinical Studies (14.1)]. 1.2 Left Ventricular Dysfunction following Myocardial Infarction 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)]. 1.3 Hypertension 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

Produkt oppsummering:

Carvedilol Tablets USP, 3.125 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1,000 Carvedilol Tablets USP, 6.25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘02’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1,000 Carvedilol Tablets USP, 12.5 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘03’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1,000 Carvedilol Tablets USP, 25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘04’ on the other side. Bottles of 100 Bottles of 500 Bottles of 1,000 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
DIRECT_RX
----------
CARVEDIDOL
1.1 Heart Failure
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), Clinical Studies (14.1)].
1.2 Left Ventricular Dysfunction following Myocardial Infarction
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)].
1.3 Hypertension
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 should be taken with food to slow the rate of
absorption and reduce
the incidence of orthostatic effects.
2.1 Heart Failure
DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN
DURING UP-TITRATION. Prior to initiation of carvedilol tablets, it is
recommended that
fluid retention be minimized. The recommended starting dose of
carvedilol tablets is
3.125 mg twice daily for 2 weeks. If tolerated, patients may have
their dose increased to
6.25 mg, 12.5 mg and 25 mg twice daily over successive intervals of at
least 2 weeks.
Patients should be maintained on lower doses if higher doses are not
tolerated. A
maximum dose of 50 mg twice daily has been administered to patients
with mild-to-
moderate heart failure weighing over 85 kg (187 lbs).
Patients should be advised that initiation of treatment and (to a
lesser extent) dosage
increases may be associated with transient symptoms of dizziness or
lightheadedness
(and rarely syncope) within the first h