Timolol-POS - instructions for use, dose, side effects, contraindications

A non-selective beta-adrenergic receptor blocker without sympathomimetic activity. With topical application lowers the intraocular pressure, by reducing the formation of watery moisture and a slight increase in its outflow. The effect manifests itself 20 minutes after instillation, the maximum effect is after 1-2 hours; duration of action is 24 hours.

Pharmacokinetics:

Timolol maleate quickly penetrates through the cornea into the tissues of the eye.In an insignificant amount enters the systemic bloodstream by absorption through the conjunctiva, the mucous membranes of the nose and the lacrimal tract. Excretion of metabolites by the kidneys. In newborns and small children, the concentration of the active substance is significantly higher than its maximum concentration in adult plasma.

Indications:

primary open-angle glaucoma;

- Secondary glaucoma (uveal, aphakic, post traumatic); -conditioned glaucoma (with ineffectiveness of other therapeutic measures);

sharp increase in ophthalmotonus;

Primary angle-closure glaucoma (in combination with miotics).

Contraindications:

chronic obstructive pulmonary disease of the severe course (COPD), including bronchial asthma;

- sinus bradycardia (slow heartbeat);

atrioventricular blockade of II and III degree;

- acute and chronic heart failure of II and III degree; -cardiogenic shock;

-dystrophic diseases of the cornea;

heavy vasomotor rhinitis;

-increased sensitivity to the components of the drug.

Carefully:

: sinoatrial blockade, arterial hypotension, children's age, especially the period of newborns,cerebrovascular insufficiency, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, simultaneous administration of other beta-blockers.

Pregnancy and lactation:

In pregnancy, the drug is used if the expected benefit to the mother exceeds the potential risk to the fetus. During the application of the drug, breastfeeding should be stopped.

Dosing and Administration:

Newborns and children under 10 years old drop by drop 0.25% solution 2 times a day. Adults and children over 10 years are instilled in the conjunctival sac 1 drop of 0.25% solution 2 times a day, with insufficient efficiency - 1 drop of 0.5% solution 2 times a day. If necessary, the dose can be reduced to 1-2 drops 1 time per day.

Before every instillation you need remove the protective cap (see Fig. 1).

Before first use of the preparation, flip the bottle dropper vertically down and Press on its bottom (bottom) several times until on the tip dropper will not appear the first drop (see Figure 2). After this, the bottle is ready to further use.

When the drug is instilled hold the bottle with a dropper Down, quickly and vigorously pressing on its bottom (bottom). Thus, is activated the dropper mechanism is removed only one a drop of the drug. Special valves dropper system design provides always the same size extracted and drops the same speed of its extraction even with a very strong pressure on the vial base. Tilt head back a little finger slightly pull the lower eyelid and drip one drop in the conjunctival sack as described above (see. Fig. 3). Slowly close your eyes.

After the procedure is finished, immediately seal the protective cap on the dropper (see Figure 4).

When instilling, avoid contact with the tip of the dropper with the surface of the eye and skin.

Side effects:

Local reactions:

Eye irritation, manifested as conjunctivitis, blepharitis, keratitis (dermahemia eyelids, itching and burning sensation in the eyes, conjunctival hyperemia, lacrimation or decrease tearing, photophobia, corneal epithelial edema, short-term disturbance of visual acuity, prolonged use may develop surface pitting ketone pathopathy (reduced transparency of the cornea) and decreased sensitivity of the cornea), ptosis, diplopia;

Systemic reactions:

From the side of the cardiovascular system: lowering blood pressure,bradycardia, bradyarrhythmia, atrioventricular blockade, heart failure, cardiac arrest, decreased myocardial contractility, chest pain, transient cerebral circulation, collapse;

On the part of the respiratory system: dyspnea, bronchospasm, pulmonary insufficiency;

From the central nervous system: dizziness, headache, drowsiness, hallucinations, slowing the speed of psychomotor reactions;

Other side effects: allergic reactions (including urticaria), rhinitis, nasal congestion, epistaxis, nausea, vomiting, diarrhea, paresthesia, muscle weakness, sexual dysfunction, depression.

Overdose:

When topical application in the recommended dose, the symptoms of an overdose were not noted. At casual intake it is possible development of following signs: a nausea, vomiting, a giddiness, a headache, depression of arterial pressure, a bronchospasm, a bradycardia. In case of symptoms of overdose, treatment is symptomatic. Isoprenaline can be administered intravenously to eliminate severe bradycardia or bronchospasm, dobutamine for the treatment of arterial hypotension.

Interaction:

Epinephrine, pilocarpine, systemic beta-blockers increase the effect. When used with reserpine - it is possible to develop severe bradycardia or hypotension (this combination requires careful medical supervision); with calcium channel blockers or cardiac glycosides - there may be a violation of atrioventricular conduction, acute left ventricular failure or arterial hypotension. Strengthens the effect of muscle relaxants (timolol should be discontinued 48 hours before the proposed general anesthesia using peripheral muscle relaxants). It can not be used simultaneously with antipsychotic drugs (neuroleptics) and anxiolytic drugs (tranquilizers). During treatment it is not recommended to take ethanol (possibly a sharp drop in blood pressure). With caution, appoint simultaneously with antihypertensive drugs, other beta-blockers, insulin or oral hypoglycemic drugs, glucocorticosteroids, psychoactive drugs.

Special instructions:

Control of efficacy should be performed approximately 3-4 weeks after the start of therapy. During the treatment period, at least once every 6 months, the function of lacrimation, the integrity of the cornea, and the field of vision should be monitored. During the treatment period, care must be taken when driving vehicles and practicing other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions and good vision (within 0.5 hours after instillation into the eye).

Contact lenses should be removed before instillation and put on not earlier than 15 minutes after it.

With prolonged use of timolol, the effect may be weakened. Before the forthcoming surgical intervention with the application of general anesthesia - within 48 hours the drug should be canceled.

The original design of the vial-dropper, operating on the principle of a vacuum pump, does not allow air from outside to penetrate into the vial and thus ensures the sterility of eye drops in the absence of a preservative in their composition.

The use of "Timolol-PIC eye drops [without preservative] avoids the undesirable effects of the preservative on the external tissues of the glaucoma.

for, conjunctiva and cornea, and also - excludes the risk of allergic reactions to the preservative.

After opening the vial and the first instillation of Timolol-PIC, eye drops [without preservative] the drug can be used for 12 weeks. To do this, mark on the vial and / or on the cardboard pack the date when you first dripped the drug. On the label of the vial and on the cardboard pack there is a special graph for filling in by the patient: "Date of first use".

After using the contents of the vial, you should purchase a new vial of the drug; the used vial is not provided for reuse and is recyclable (discard the used vial in the bin)

Form release / dosage:

Eye drops [without preservative] 0.25%, 0.5%.

For 10 ml in multidose bottles of plastic. The bottle together with the instructions for use are placed in a cardboard box.

Packaging:

For 10 ml in multidose bottles of plastic. The bottle together with the instructions for use are placed in a cardboard box.

Storage conditions:

List B. At a temperature of no higher than 25 ° C. Keep out of the reach of children!

Shelf life:

In closed original packaging: 3 years.

After opening the bottle 12 weeks.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001055/08

Date of registration:26/02/2008

The owner of the registration certificate:Ursafarm Artsnaymittel GmbHUrsafarm Artsnaymittel GmbH Germany

Manufacturer: & nbsp

URSAPHARM Arzneimittel, GmbH Germany

Information update date: & nbsp31.08.2015

Illustrated instructions

Instructions

drawings

Timolol-POS® (Timolol-POS®)