A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Sectral Indications, Dosage, Storage, Stability - Acebutolol
Sectral Indications, Dosage, Storage, Stability - Acebutolol
INDICATIONS
Hypertension
Acebutolol hydrochloride
capsules are indicated for the management of hypertension in adults. They
may be used alone or in combination with other antihypertensive agents,
especially thiazide-type diuretics.
Ventricular Arrhythmias
Acebutolol hydrochloride
capsules are indicated in the management of ventricular premature
beats; it reduces the total number
of premature beats, as well
as the number of paired and
multi-form ventricular
ectopic beats, and R-on-T
beats.
DOSAGE AND ADMINISTRATION
Hypertension
The initial dosage
of acebutolol in uncomplicated mild-to- moderate hypertension is 400 mg.
This can be given as a single daily dose, but in occasional patients twice
daily dosing may be required for adequate 24-hour blood-pressure control.
An optimal response
is usually achieved with dosages of 400 to 800 mg
per day, although some patients
have been maintained on as little as 200 mg
per day. Patients with more severe
hypertension or who have
demonstrated inadequate control
may respond to a total of 1200 mg daily (administered b.i.d.), or to the
addition of a second antihypertensive
agent. ß-1 selectivity diminishes as dosage
is increased.
Ventricular Arrhythmia
The usual initial dosage
of acebutolol is 400 mg daily given
as 200 mg b.i.d. Dosage should
be increased gradually until an optimal clinical response is obtained,
generally at 600 to 1200 mg per
day. If treatment is to be discontinued, the dosage
should be reduced gradually over a period of about two weeks.
Use in Older Patients
Older patients have an approximately 2-fold increase in bioavailability
and may require lower maintenance doses. Doses above 800 mg/day should
be avoided in the elderly.
HOW SUPPLIED
Acebutolol Hydrochloride Capsules are available containing 200 mg
or 400 mg of acebutolol as the
hydrochloride salt.
The 200 mg product
is a medium orange opaque
and medium orange opaque capsule
marked with MYLAN over 1200 on both the body and cap.
They are available as follows:
The 400 mg product
is a medium orange opaque
and medium orange opaque capsule
marked with MYLAN over 1400 on both the body and cap.
They are available as follows:
STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F).
PROTECT FROM LIGHT.
Keep container tightly
closed.
Dispense in a tight, light-resistant container
as defined in the USP using a child-resistant closure.
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