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
Inderal LA Indications, Dosage, Storage, Stability - Propranolol
Inderal LA Indications, Dosage, Storage, Stability - Propranolol
INDICATIONS AND USAGE
Hypertension
Inderal LA is indicated in the management of hypertension;
it may be used alone or used in combination with other antihypertensive agents,
particularly a thiazide diuretic. Inderal LA is not indicated in the management
of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Inderal LA is indicated for the long-term management of patients
with angina pectoris.
Migraine
Inderal LA is indicated for the prophylaxis of common migraine
headache. The efficacy of propranolol in the treatment of a migraine attack
that has started has not been established, and propranolol is not indicated
for such use.
Hypertrophic Subaortic Stenosis
Inderal LA is useful in the management of hypertrophic subaortic
stenosis, especially for treatment of exertional or other stress-induced angina,
palpitations, and syncope. Inderal LA also improves exercise performance. The
effectiveness of propranolol hydrochloride in this disease appears to be due
to a reduction of the elevated outflow pressure gradient, which is exacerbated
by beta-receptor stimulation. Clinical improvement may be temporary.
DOSAGE AND ADMINISTRATION
InderalÒLA (propranolol
hydrochloride) provides propranolol hydrochloride in a sustained-release capsule
for administration once daily. If patients are switched from Inderal Tablets
to Inderal LA Capsules, care should be taken to assure that the desired therapeutic
effect is maintained. Inderal LA should not be considered a simple mg-for-mg
substitute for Inderal. Inderal LA has different kinetics and produces lower
blood levels. Retitration may be necessary, especially to maintain effectiveness
at the end of the 24-hour dosing interval.
Hypertension
Dosage must be individualized. The usual initial dosage
is 80 mg Inderal LA once daily, whether used alone or added to a diuretic. The
dosage may be increased to 120 mg once daily or higher until adequate blood
pressure control is achieved. The usual maintenance dosage is 120 to 160 mg
once daily. In some instances a dosage of 640 mg may be required. The time needed
for full hypertensive response to a given dosage is variable and may range from
a few days to several weeks.
Angina Pectoris
Dosage must be individualized. Starting with 80 mg Inderal
LA once daily, dosage should be gradually increased at three- to seven-day intervals
until optimal response is obtained. Although individual patients may respond
at any dosage level, the average optimal dosage appears to be 160 mg once daily.
In angina pectoris, the value and safety of dosage exceeding 320 mg per day
have not been established.
If treatment is to be discontinued, reduce dosage gradually
over a period of a few weeks (see "WARNINGS").
Migraine
Dosage must be individualized. The initial oral dose
is 80 mg Inderal LA once daily. The usual effective dose range is 160 to 240
mg once daily. The dosage may be increased gradually to achieve optimal migraine
prophylaxis. If a satisfactory response is not obtained within four to six weeks
after reaching the maximal dose, Inderal LA therapy should be discontinued.
It may be advisable to withdraw the drug gradually over a period of several
weeks.
Hypertrophic Subaortic Stenosis
80 to 160 mg Inderal LA once daily.
Pediatric Dosage
At this time the data on the use of the drug in this age group
are too limited to permit adequate directions for use.
HOW SUPPLIED
InderalÒLA Capsules
(propranolol hydrochloride)
Each white/light-blue capsule, identified by 3 narrow bands,
1 wide band, and "INDERAL LA 60," contains 60 mg of propranolol hydrochloride
in bottles of 100 (NDC 0046-0470-81).
Each light-blue capsule, identified by 3 narrow bands, 1 wide
band, and "INDERAL LA 80," contains 80 mg of propranolol hydrochloride
in bottles of 100 (NDC 0046-0471-81).
Each light-blue/dark-blue capsule, identified by 3 narrow bands,
1 wide band, and "INDERAL LA 120," contains 120 mg of propranolol
hydrochloride in bottles of 100 (NDC 0046-0473-81).
Each dark-blue capsule, identified by 3 narrow bands, 1 wide
band, and "INDERAL LA 160," contains 160 mg of propranolol hydrochloride
in bottles of 100 (NDC 0046-0479-81).
The appearance of these capsules is a registered trademark
of Wyeth Pharmaceuticals.
Store at controlled room temperature 20°to
25°C (68°to
77°F). Protect from light, moisture, freezing,
and excessive heat.
Dispense in a tight, light-resistant container as defined in
the USP.
Wyeth Pharmaceuticals Inc. W10478C002 Philadelphia,
PA 19101 ET01 Rev 11/03
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