TIMIXOL

Eye-drops 0,5%

Formula and form of issue:

Eye-drops: 5ml in bottle 1ml Timolol maleate- 5mg (0,5%)

Pharmacological action:

Antiglaucomic agent. Belongs to beta-adrenergic blocking agents group. Lowers internal eye pressure, mainly bу means of decreasing aqueous humour and improving its outflow. Maximal effect is observed in 2–4 hours. Duration of action is 24 hours.

Compared to miotics, Timixol lowers internal eye pressure practically not influencing pupil’s size and accommodation.

Pharmacokinetics:

• Chronical open-angle glaucoma
• Some cases of secondary glaucoma
• Eye hypertension
• Aphakia in glaucoma
• In patients with narrow chamber angle and indication of previous spontaneous and iatrogenic angle block of another eye, to whom lowering of eye pressure is prescribed.

Dosage regime:

Adults: Primary dose is 1 drop of a 0,5% solution in the affected eye once daily. In the following- 1–2 drops 2 times a day.

If necessary Timixol can be combined with miotics and epinephrine, as well as with systemic prescription of carbonic anhydrase.

Evaluation of treatment results is carried out by measuring intraocular pressure in 4 weeks after the beginning of treatment. When reaching optimal effect patient can be shifted to maintenance dose of the preparation: 1 drop in the affected eye once daily.

While shifting the patient who is getting local therapy by another beta-adrenergic blocking agent to Timixol, application of the preceding preparation should be stopped after taking its regular daily dose, and application of Timixol is prescribed on the following day. If a patient was previously getting monotherapy by one of the antiglaucomic agents, not belonging to beta-adrenergic blocking agents group, then application of this preparation should be continued adding instillation of one 0,5% drop of Timixol solution in the affected eye once daily. On the following day treatment by previous preparation should be completely withheld and Timixol treatment should be continued.

Side effects:

• Visual organs: symptoms of local irritation (1%), conjunctivitis, blepharitis, keratitis, cornea desensitization (less than 1%). Changes in refringence are in some cases connected with miotics cancellation.
• Cardiovascular system: (less than 1%) bradycardia, hypotension, myocard asequence.
• Respiratory system: (less than 1%) bronchospasm (mainly in inclinable patients), dyspnea.
• Central nervous system: (less than 1%) headache, astenisation, dizziness.
• Gastrointestinal tract: (less than 1%) sickness
• Allergic reactions: (less than 1%) local and generalized skin rash, hives.

Contraindications:

• Bronchial asthma or indication of bronchial asthma in history
• Severe chronical obstructive respiratory diseases
• Sinus bradycardia
• AV block of II–III degree
• Cardiogenic shock
• Hypersensitivity to any component of the preparation

Special remarks:

In local application of Timixol side effects can be observed, typical for systemic use of beta-adrenergic blocking agents.

Before starting to use Timixol heart failure should compensated.

In patients with sever heart disease in history it is necessary to exclude all the signs of heart failure and to observe blood pressure constantly.

Patients who are already taking beta-adrenergic blocking agents and are prescribed Timixol, should be observed in the connection of summary action of internal eye pressure and systemic effects of beta-adrenergic blocking agents.

If Timixol is used for lowering internal eye pressure in closed-angle glaucoma, then it should be prescribed only in combination with miotics.

Timixol wasn’t observed in patients wearing contact lenses. Half-life time of gel solution from the eye according to clinical research is 30 minutes.

Safety and efficiency of Timixol during pregnancy are not studied. When prescribing Timixol during lactation period, breast-feeding should be stopped as timolol is eliminated with milk.

Overdosage:

Up to the present times no cases of overdosage have been reported. Symptomatic bradycardia, hypotension, bronchospasm are considered to be possible symptoms of beta-adrenergic blocking agents overdosage. Treatment is symptomatic. The preparation is slowly eliminated in dialysis.

Drug interaction:

Simultaneous prescription of adrenalin may lead to mydriasis.

There is potential danger of additive effect with the development of hypotension and/or significant bradycardia when Timixol is used simultaneously with calcium channel blocking agents, and medicines lowering the amount of catecholamines and beta-adrenergic blocking agents in the organism.

Storage conditions: Should be stored under temperature -not above 25˚ С in the dark place.

Keep out of reach of children.

Expiry period: Do not take the preparation after the expiry date printed on the package. After unsealing the bottle, expiry date — 30 days