DOSAGE AND ADMINISTRATION
The usual
starting dose is 1 drop of 0.25% Health 2000
Timolol maleate 0.5% eye drops in the affected eye(s) twice
a day. If the clinical response is not adequate, the dosage may be changed
to 1 drop of 0.5% solution in the affected eye(s) twice a day.
Health 2000 Timolol maleate 0.5% eye drops may require a few weeks to stabilize,
evaluation should include a determination of intraocular pressure after approximately
4 weeks of treatment with Health 2000 Timolol maleate 0.5% eye drops. If the
intraocular pressure is maintained at satisfactory levels, the dosage schedule
may be changed to 1 drop once a day in the affected eye(s).
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
Treatment of elevated intraocular pressure in patients with ocular hypertension, chronic open angle glaucoma, secondary glaucoma, aphakic glaucoma.
(iii) DESCRIPTION OF DOSAGE FORM
Timolol
maleate is a nonselective beta-adrenergic receptor blocking agent that does
not have significant intrinsic sympathomimetic, direct myocardial depressant,
or local anaesthetic (membrane stabilising) activity.Health 2000 Timolol maleate
0.5% eye drops reduce elevated and normal intraocular pressure whether or
not associated with glaucoma.
(iv) CONTRAINDICATIONS
Health 2000 Timolol maleate 0.5% eye drops Eye Drops are contraindicated in the following conditions: bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease; sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock; hypersensitivity to any component of the product.
WARNING
AND PRECAUTIONS
Product may have sulfites, which may cause allergic-type reactions In susceptible
patients; may exacerbate or precipitate heart block, asthma, chronic obstructive
pulmonary disease, and mental changes (especially in elderly patients)
USE
IN PREGNANCY C -
Safety for use during pregnancy has not been established. Timolol should be
used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
NURSING MOTHERS
Timolol maleate has been detected in human milk following oral and ophthalamic
drug administration.Because of the potential for serious adverse reactions
from Timolol in nursing infants , a decision should be made whether to discontinue
nursing or to discontinue the drug , taking into account the importance of
the drug to the mother.
PADEIATRIC USE
Safety and effectiveness in pediatric patients have not been established.
INTERACTION
It is not recommended to use two ophthalmic beta-blockers at the same time.
Special caution is warranted in people taking antidiabetic drugs, as timolol
may mask symptoms of low blood sugar. Consult your doctor for specific advice
if you are taking any other prescription or over-the-counter medication.
FOOD
INTERACTIONS
No known food interactions
DISEASE
INTERACTIONS
Caution is advised when taking timolol. Consult your doctor if you have any
of the following: asthma, emphysema or another lung disease, low blood sugar,
heart disease, blood vessel disease, or an overactive thyroid. In diabetes,
timolol can affect blood sugar levels or mask symptoms of low blood sugar.
(v)
SIDE EFFECTS
Serious Side Effects-Palpitations; trouble breathing; dizziness and weakness
caused by low blood pressure. Call your doctor right away.
Common Side Effects-Stinging or irritation of the eye when drops are applied;
tearing
Less Common Side Effects-Decreased night vision; eyebrow pain; crusted eyelashes;
dry eyes; increased sensitivity of eyes to light; redness, stinging, burning,
watering, or other irritation of the eye; droopy eyelid; eye inflammation
(vi) TOXIC EFFECTS
TERATOGENICITY
No epidemiological studies of congenital abnormalities among infants born
to women treated with timolol during pregnancy have been reported.
MUTAGENICITY
Timolol has not caused birth defects in animals. Human studies have not been
completed.
CARCINOGENICITY
In a lifetime study in mice, there were statistically significant increases
in the incidence of benign and malignant pulmonary tumors, benign uterine
polyps and mammary adenocarcinoma in female mice at 500 mg/kg/day, (approximately
400 times** the maximum recommended daily human dose), but not at 5 or 50
mg/kg/day. In a subsequent study in female mice, in which post-mortem examinations
were limited to uterus and lungs, a statistically significant increase in
the incidence of pulmonary tumors was again observed at 500 mg/kg/day.