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
Timoptic Indications, Dosage, Storage, Stability - Timolol Maleate
Timoptic Indications, Dosage, Storage, Stability - Timolol Maleate
INDICATIONS
Tablets
Hypertension: Timolol maleate is indicated for the
treatment of hypertension. It may be used alone or in combination
with other antihypertensive agents, especially thiazide-type diuretics.
Myocardial Infarction: Timolol maleate is indicated
in patients who have survived the acute
phase of myocardial
infarction, and are clinically stable, to reduce
cardiovascular
mortality and the risk of reinfarction.
Migraine: Timolol maleate is indicated for the prophylaxis
of migraine headache.
Ophthalmic Solutions and Ophthalmic Gel Forming Solution
Timolol maleate is indicated in the treatment
of elevated intraocular pressure in patients with ocular
hypertension or
open-angle glaucoma.
Additional Information for Preservative-Free Ophthalmic Solution:
Preservative-free timolol maleate may be used when a patient
is sensitive to the preservative
in timolol maleate, benzalkonium chloride, or when use of a preservative-free
topical medication
is advisable.
DOSAGE AND ADMINISTRATION
Tablets
Hypertension: The usual initial
dosage of timolol maleate
is 10 mg twice a day, whether
used alone or added to diuretic
therapy. Dosage may be increased or decreased depending on heart
rate and blood pressure
response. The usual total maintenance dosage
is 20-40 mg per
day. Increases in dosage
to a maximum of 60 mg
per day divided into two
doses may be necessary. There should be an interval
of at least seven days between increases in dosages.
Timolol maleate may be used with a thiazide diuretic
or with other antihypertensive agents. Patients should be observed
carefully during initiation of such concomitant therapy.
Myocardial Infarction: The recommended dosage
for long-term prophylactic use in patients who have survived the
acute phase
of a myocardial infarction is 10 mg
given twice daily (see CLINICAL PHARMACOLOGY).
Migraine: The usual initial
dosage of timolol maleate
is 10 mg twice a day. During
maintenance therapy the 20 mg
daily dosage may be administered as a single dose. Total daily dosage
may be increased to a maximum
of 30 mg, given in divided doses, or decreased to 10 mg
once per day depending on clinical
response and tolerability.
If a satisfactory response is not obtained after 6-8 weeks use of
the maximum daily dosage,
therapy with timolol maleate should be discontinued.
Ophthalmic Solutions
Timolol maleate ophthalmic
solution is available
in concentrations of 0.25 and 0.5%. The usual starting dose
is one drop of 0.25% timolol
maleate in the affected eye(s) twice a day. If the clinical
response is not adequate,
the dosage may be changed
to one drop of 0.5% solution
in the affected eye(s) twice a day. Additional Information for
Preservative-Free Ophthalmic Solution: Apply enough gentle pressure
on the individual container to obtain a single drop
of solution.
Since in some patients the pressure-lowering response
to timolol maleate may require a few weeks to stabilize, evaluation
should include a determination of intraocular
pressure after approximately
4 weeks of treatment
with timolol maleate.
If the intraocular
pressure is maintained
at satisfactory levels, the dosage schedule
may be changed to one drop
once a day in the affected eye(s). Because of diurnal
variations in intraocular
pressure, satisfactory response to the once-a-day dose
is best determined by measuring the intraocular pressure at different
times during the day.
Dosages above one drop
of 0.5% timolol maleate twice a day generally have not been shown
to produce further reduction
in intraocular pressure.
If the patient's intraocular
pressure is still not
at a satisfactory level on this regimen, concomitant
therapy with other agents(s) for lowering intraocular pressure
can be instituted, taking into consideration, for the preservative-free
opthalmic solution, that the preparation(s) used concomitantly may
contain one or more preservatives. The concomitant
use of two topical beta-adrenergic
blocking agents is
not recommended (see DRUG INTERACTIONS,
Beta-adrenergic Blocking Agents).
Additional Information for Preservative-Free Ophthalmic Solution:
Preservative-free Timoptic in Ocudose is a sterile
solution that does
not contain a preservative. The solution
from one individual unit
is to used immediately after opening
for administration
to one or both eyes. Since sterility cannot be guaranteed after
the individual unit is
opened, the remaining contents should be discarded immediately after
administration.
Ophthalmic Gel Forming Solution
Patients should be instructed to invert
the closed container
and shake once before each use. It is not necessary to shake the
container more than
once. Other topically applied ophthalmic
medications should be administered at least 10 minutes before timolol
maleate ophthalmic
gel forming solution (see
PRECAUTIONS, Information for
the Patient and PATIENT PACKAGE
INSERT).
Timolol maleate ophthalmic
gel forming solution
is available in concentrations of 0.25% and 0.5%. The dose
is one drop of timolol
maleate ophthalmic
gel forming solution
(either 0.25% or 0.5%) in the affected eye(s) once a day.
Because in some patients the pressure-lowering response
to timolol maleate ophthalmic gel
forming solution may
require a few weeks to stabilize, evaluation should include a determination
of intraocular pressure
after approximately 4 weeks of treatment
with timolol maleate ophthalmic
gel forming solution.
Dosages higher than one drop
of 0.5% timolol maleate ophthalmic
gel forming solution
once a day have not been studied. If the patient's intraocular pressure
is still not at a satisfactory level on this regimen, concomitant
therapy can be considered. The concomitant
use of two topical beta-adrenergic
blocking agents is not recommended (see DRUG
INTERACTIONS, Beta-adrenergic Blocking Agents).
When patients have been switched from therapy with timolol maleate ophthalmic
solution administered twice daily to timolol maleate ophthalmic
gel forming solution administered
once daily, the ocular hypotensive
effect has remained consistent.
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