Normatin (Eye Drops)
Each ml contains in 0.5% solution timolol maleate 6.83 mg.
Increased intraocular pressure (eye hypertension);
- Glaucoma simplex;
- Aphakic glaucoma and other types of secondary glaucoma;
- Adjuvant agent for increasing of intraocular pressure in case of angle-closure
glaucoma (in combination with miotics);
- Congenital glaucoma (other therapy failure).
Normatin is not prescribed in the following cases:
Hypersensitization to drug ingredients, bronchial asthma (including in past
history), severe chronic obstructive diseases of lungs, cardiogenic shock, acute
and severe cardiac insufficiency, atrioventricular heart block (degree II and
III), sinoauricular block, sinus bradycardia (less than 45-50 strokes/min), sick
sinus syndrome, dystrophic cornea diseases, severe allergic inflammations of
mucous membrane of nose, breast-feeding, infancy (prematures and newborns).
Local reactions: irritation and hyperemia of eye conjunctiva, lacrimation,
photophobia, epithelium edema and cornea hyperemia, and diplopia. Systemic
reactions have been rarely observed. Effects on cardiovascular system:
bradycardia, bradyarrhythmia, hypotension, collapse, atrioventricular heart
block. Effects on respiratory system: dyspnea, bronchospasm, pulmonary
insufficiency. Effects on CNS: headache, vertigo. Allergic reactions: urticaria,
DOSAGE AND ADMINISTRATION
The initial dose of the drug is 1 drop of 0.25% solution twice a day. If the
clinical response is not adequate, the dosage may be changed to one drop of 0.5%
solution twice a day. Since stabilization of intraocular pressure after
initiation of therapy occurs within a few weeks, treatment effect is evaluated
after 4 weeks. Starting a patient on timolol who previously received topical
therapy with other beta-blocker should be done next day following administration
of appropriate daily dose of the latter. The initial dose is 1 drop of 0.25%
solution two times a day into affected eye. If there is no adequate effect the
dose may be increased till 1 drop of 0.5% solution 2 times a day. Monotherapy
with one topical antiglaucomal agent not related to beta-blockers group should
be added by prescription of timolol. The dose is 1 drop of 0.25% solution in
affected eye 2 times a day. Next day previously applied antiglaucomal agent is
withdrawn and then the treatment is continued with timolol. If required the dose
of timolol may be increased till 1 drop of 0.5% solution 2 times a day.
If a patient wears soft contact lenses he should not apply Normatin eye drops
since Normatin contains a preservative, which may be absorbed by contact lenses
and has unfavorable effects on eye tissues. Hard contact lenses should be
removed immediately prior to administration of Normatin and reinserted 15
minutes following application.
PREGNANCY AND LACTATION
The drug should be prescribed during pregnancy only if treatment efficacy
justifies potential risk for fetus.
The breast-feeding should be ceased during treatment.
5 ml in a plastic vial with a dropper and screw cup. Vial with a dropper is in a
carton box with a leaflet.