Офтан® Timololum

General characteristics. Structure:

Active ingredient: 3,42 mg or 6,84 mg of Timololum of a maleate that sootvetstut 2,5 mg and 5 mg of Timololum.

Excipients: a benzalkoniya chloride, sodium hydrophosphate, hydrophosphate sodium dodecahydrate, sodium hydroxide, water for and.

Pharmacological properties:

Pharmacodynamics. Protivoglaukomny drug, non-selective beta adrenoblocker. Has no internal sympathomimetic and membrane stabilizing activity. At topical administration in the form of eye drops Timololum reduces both the normal, and increased intraocular pressure due to reduction of formation of intraocular liquid. Does not exert impact on the size of a pupil and accommodation.

Effect of drug is shown in 20 min. after an instillation in a conjunctival cavity. The maximum decrease in intraocular pressure occurs in 1-2 h and remains during 24 h.

Pharmacokinetics. At topical administration of Timololum the maleate quickly gets through a cornea. After instillation of eye drops the maximum concentration of Timololum in watery moisture of an eye is reached in 1-2 hours.

80% of Timololum applied in the form of eye drops get to a system blood stream by absorption through vessels of a conjunctiva, mucous a nose and the lacrimal path. Removal of metabolites of Timololum is carried out preferential by kidneys.

Newborns and small children have a concentration of Timololum. as active agent, significantly exceeds its maximum concentration (Cmax) in a blood plasma of adults.

Indications to use:

— the increased intraocular pressure (oftalmogipertenziya);

— open angle glaucoma;

— glaucoma on an afakichesky eye and other types of secondary glaucoma;

— as an additional tool for decrease in intraocular pressure at closed-angle glaucoma (in a combination from miotika);

— inborn glaucoma (at inefficiency of other means).

Route of administration and doses:

In an initiation of treatment appoint on 1-2 drops in the affected eye in the form of drops eye 0.25% or a thaw of eye 0.5% of 2 times/days.

If intraocular pressure at regular use is normalized, it is necessary to lower a dose to 1 drop of 1 times/days in the morning.

Treatment of Oftan® Timololum is carried out, as a rule, for an appreciable length of time. Having rummaged in treatment or change of a dosage of drug are carried out only according to the instruction of the attending physician.

Features of use:

Use at pregnancy and feeding by a breast. There is no sufficient experiment on use of drug at pregnancy and in the period of a lactation, however is established that Timololum gets through a placental barrier and is allocated with breast milk. To destination the attending physician of Oftan® Timololum can be applied at pregnancy and during breastfeeding in cases when the expected medical effect for mother justifies potential risk for a fruit and the child.

If drug was used just before childbirth or during breastfeeding, then newborns should provide careful observation within several days after the birth and during the entire period of treatment of nursing mothers with the drug Oftan® Timololum.

Use for children. Due to the lack of data on efficiency and safety use of drug for children and teenagers in an ovzrasta up to 18 years contraindicated.

Control of efficiency of drug is recommended to be carried out approximately in 3-4 weeks after the beginning of therapy (not earlier than in 1-2 weeks). At prolonged use of Timololum easing of effect is possible.

At use it is necessary to control lacrimation function, a condition of a cornea and to estimate the size of fields of vision at least 1 time in 6 months.

Офтан® Timololum contains preservative a benzalkoniya chloride which can cause irritation of eyes, be absorbed by soft contact lenses, causing change of their color and to make an adverse effect on eye tissues. Contact lenses should be removed before use of drug and if necessary to establish them again not earlier than in 15 min. after instillation.

At transfer of patients into treatment with Timololum correction of the changes of a refraction caused by the miotika applied earlier can be required.

Офтан® Timololum, like other beta adrenoblockers, can mask possible symptoms of a hypoglycemia at patients with a diabetes mellitus.

In case of the forthcoming operative measure under the general anesthesia, it is necessary to cancel drug for 48 h before operation since Timololum strengthens action of muscle relaxants and the general anesthetics.

It is not necessary to dig in two various beta adrenoblockers in the same eye.

Influence on ability to driving of motor transport and to control of mechanisms

During treatment it is necessary to be careful at control of motor transport and during work with the difficult equipment, demanding increased concentration of attention, speed of psychomotor reactions and good sight (within 30 min. after an instillation in an eye) since drug can lower the ABP, cause fatigue and dizziness.

Side effects:

Local reactions. From an organ of sight: sight misting, irritation and hyperemia of a conjunctiva, burning and itch of eyes, dacryagogue, cornea epithelium hypostasis, dot superficial keratopathy, cornea hyperesthesia, syndrome of a dry eye, blepharitis, conjunctivitis and keratitis. At prolonged use development of a ptosis is possible and it is rare - diplopias. When carrying out the fistuliziruyushchy (getting) antiglaukomny operations development of amotio of a choroid in the postoperative period is possible.

System reactions. From cardiovascular system: bradycardia, bradyarrhythmia, decrease in the ABP, collapse, heart block, tranzitorny disturbances of cerebral circulation, exacerbation of chronic heart failure, stethalgia.

From the alimentary system: nausea, diarrhea.

From respiratory system: nose congestion, asthma, bronchospasm, pulmonary insufficiency.

From TsNS and peripheral nervous system: headache, dizziness, weakness, confusion of consciousness, hallucination, sleeplessness, oneirodynia, alarm, change of mood, paresthesia.

From integuments: alopecia, psoriazopodobny rashes and exacerbation of psoriasis.

From urinogenital system: Peyroni's disease, decrease in a potentiality.

Allergic reactions: generalized or local rash, itch.

Others: a myasthenia, a ring in ears.

Interaction with other medicines:

Combined use of the drug Oftan® Timololum with the eye drops containing adrenaline can cause a mydriasis.

At simultaneous use of the eye drops containing Epinephrinum and Pilocarpinum strengthening of decrease in intraocular pressure is possible.

Arterial hypotension and bradycardia can amplify at simultaneous use of Oftan® of Timololum with antagonists of calcium, Reserpinum and system beta adrenoblockers.

CYP2D6 isoenzyme inhibitors, such as quinidine and Cimetidinum, can increase concentration of Timololum in plasma.

Simultaneous use with insulin or peroral hypoglycemic means can lead to a hypoglycemia.

Timololum strengthens action of muscle relaxants therefore drug withdrawal for 48 h to the planned surgical intervention under the general anesthesia is necessary. These data can belong also to medicines which were applied shortly before it.

Contraindications:

— bronchial asthma or other heavy chronic obstructive respiratory diseases;

— sinus bradycardia;

— AV blockade of II and III degrees;

— dekompensirovanny heart failure;

— dystrophic processes in a cornea;

— children's and teenage age up to 18 years (due to the lack of data on efficiency and safety of use of drug for children and teenagers);

— hypersensitivity to drug components.

With care it is necessary to appoint drug at pulmonary insufficiency, heavy cerebrovascular insufficiency, heart failure in a stage of compensation, arterial hypotension, a diabetes mellitus, a hypoglycemia, a thyrotoxicosis, a myasthenia, Reynaud's syndrome, a pheochromocytoma, atrophic rhinitis, and also at co-administration of other beta adrenoblockers and psychoactive medicines which strengthen allocation of Epinephrinum.

Overdose:

Symptoms: development of the system effects characteristic of beta adrenoblockers (dizziness, a headache, arrhythmia, bradycardia, a bronchospasm, nausea and vomiting) is possible.

Treatment: to immediately wash out eyes water or normal saline solution, carry out symptomatic therapy.

Storage conditions:

List B. Drug should be stored in the place, unavailable to children, at a temperature from 15 °C to 25 °C. A period of validity - 3 years. After opening of a bottle a drug period of storage - 1 month.

Issue conditions:

According to the recipe

Packaging:

5 ml - bottles polyethylene (1) with traffic jams droppers - packs cardboard.