NORMATIN

Normatin (Eye Drops)
(Timolol maleate)

 

COMPOSITION
Each ml contains in 0.5% solution timolol maleate 6.83 mg.

THERAPEUTIC INDICATIONS
 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).

CONTRAINDICATIONS
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).

ADVERSE EFFECTS
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, eczema.

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 Next day previously applied antiglaucomal agent is withdrawn and then the treatment is continued with timolol.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.

PRECAUTIONS
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.

MANUFACTURED FORM
5 ml in a plastic vial with a dropper and screw cup. Vial with a dropper is in a carton box with a leaflet