Фотил®

General characteristics. Structure:

Active ingredients: 20 mg of Pilocarpinum of a hydrochloride, 6,84 mg of Timololum of a maleate that corresponds to 5 mg of Timololum.

Excipients: a benzalkoniya chloride, citric acid, sodium citrate, a gipromelloza, water for and.

The combined protivoglaukomny drug.

Pharmacological properties:

Pharmacodynamics. Pilocarpinum - m cholinomimetic. At an instillation in an eye Pilocarpinum causes a miosis, a spasm of accommodation and reduces intraocular pressure. Decrease in intraocular pressure is caused by reduction of a tsiliarny muscle and muscle of an iris of the eye of an eye which leads to expansion of a corner of an anterior chamber of an eye and changes physical structure of trabecular network, facilitating outflow of watery moisture. This effect remains of 4 h to 14 h.

Timololum, being beta adrenoblocker, prevents binding of sympathomimetic neurotransmitters with β1-and β2-адренорецепторами in a ciliary body. Reduces intraocular pressure, reducing products of watery moisture. The hypotensive effect occurs in 20 min. after instillation, reaches a maximum in 2 h and about 24 p proceed.

Pharmacokinetics. Pilocarpinum well gets through a cornea. Concentration in watery moisture reaches the maximum in 30 min. Pilocarpinum communicates many tissues of an eye. T1/2 makes 1.5-2.5 h of environments of an eye. Pilocarpinum is removed in not changed view with intraocular liquid.

Its combination with Timololum which reduces formation of watery moisture slows down the speed of removal of Pilocarpinum.

Pilocarpinum is quickly hydrolyzed on inactive forms in a blood plasma and a liver. T1/2 makes less than 0.5 h.

Timololum quickly gets through a cornea into watery moisture of an anterior chamber of an eye. About 80% of Timololum applied locally get into a system blood stream. Cmax in a blood plasma is defined approximately by 1 h after installation of eye drops.

It is metabolized, generally in a liver. T1/2 makes 2-5 h. It is removed preferential through kidneys.

Indications to use:

Glaucoma or the increased intraocular pressure when the combination of Timololum and Pilocarpinum is necessary:

— open angle glaucoma;

— closed-angle glaucoma;

— secondary glaucoma;

— increase in intraocular pressure after ophthalmologic operations.

Route of administration and doses:

Appoint on 1 drop in the affected eye of 2 times/days. At some patients stable decrease in intraocular pressure is reached only in several weeks of therapy. Therefore at assessment of results of treatment it is necessary to take measurement of intraocular pressure approximately in 4 weeks after an initiation of treatment. If there is no expected decrease in intraocular pressure, then it is necessary to appoint Fotil® forte on 1 drop of 2 times/days.

Features of use:

Use at pregnancy and feeding by a breast. Use of the drug Fotil® at pregnancy and during breastfeeding is possible only in that case when the estimated advantage for mother exceeds potential risk for a fruit or the child.

Use for children. Contraindication: children's age up to 18 years (due to the lack of data on efficiency and safety of use of drug for children and teenagers up to 18 years).

Eye drops of Fotil® should not be applied along with other eye drops containing beta adrenoblockers.

Use of other eye drops should be stopped before therapy is begun with the drug Fotil®. The previous protivoglaukomny drug should be cancelled, and to begin therapy with eye drops of Fotil® next day.

Assessment of efficiency of effect of drug should be carried out in 4 weeks after an initiation of treatment at regular control of intraocular pressure.

Further treatment also should be carried out at regular control of intraocular pressure.

Eye drops of Fotil® contain in quality of preservative a benzalkoniya chloride, and they are not recommended to be used when carrying contact lenses. Before use of drug it is necessary to remove contact lenses and again to establish them not earlier than in 15 min. after drug instillation.

Timololum which is a part of drug can mask hypoglycemia symptoms at patients with a diabetes mellitus or symptoms of hyperfunction of a thyroid gland.

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

Influence on ability to driving of motor transport and to control of mechanisms. The miotic effect can cause passing deterioration in sight (feeling of short-sightedness) therefore during treatment it is necessary to be careful when driving motor transport or operation of any difficult equipment demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Local reactions: the sight misting, irritation of an eye which are quickly passing burning sensation and eye pain, strengthening of dacryagogue, a syndrome of a dry eye, dermatitis a century, reddening of a conjunctiva, a spasm of a tsiliarny muscle and the induced myopia, decrease in visual acuity at insufficient lighting (owing to a miosis), decrease in sensitivity of a cornea, a dot keratitis, allergic blefarokonjyunktivit; very seldom - a diplopia and a ptosis.

Several cases of amotio of a retina, rigidity of an iris or formation of a cyst in an iris of the eye of an eye were noted in connection with use of miotocs. At long use of Pilocarpinum the reversible phacoscotasmus was observed.

System reactions: nausea, diarrhea, the increased sweating, the increased salivation, decrease in the ABP, an exacerbation of bronchial asthma, heart failure, bradycardia, arrhythmia, temporal and supraorbital headaches, skin rash.

Timololum gets through GEB and makes impact on TsNS.

With heart failure Timololum can make an asthenic syndrome, sick, dizziness, concern, hallucinations, a headache and a depression all patients.

The nose congestion was very seldom noted.

Interaction with other medicines:

At simultaneous use of Fotil with the drugs promoting release of catecholamines (for example, with Reserpinum), arterial hypotension (including orthostatic), bradycardia, dizziness were observed.

Simultaneous use of beta adrenoblockers and blockers of slow calcium channels of systemic action leads to strengthening of their pharmacological effect and increases risk of development of disturbances of cordial conductivity and arterial hypotension.

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

Contraindications:

— front uveitis;

— sinus bradycardia;

— AV blockade of II and III degrees;

— dekompensirovanny heart failure;

— cardiogenic shock;

— bronchial asthma;

— HOBL;

— 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);

— a state directly after ophthalmologic operations and other diseases of eyes at which narrowing of a pupil is undesirable;

— hypersensitivity to drug components.

With care it is necessary to appoint drug at heart failure, cerebrovascular frustration, a diabetes mellitus, a hypoglycemia, amotio of a retina, a myopia, a thyrotoxicosis, before surgeries under the general anesthesia.

Overdose:

Symptoms: bradycardia, arterial hypotension, bronchospasm, acute heart failure.

Treatment: carry out symptomatic therapy. Atropine can be used as Pilocarpinum antidote. Purpose of an izoprenalin in/in is shown at the expressed bradycardia, a bronchospasm; Dobutaminum - at arterial hypotension.

Storage conditions:

List B. Drug should be stored in the place, unavailable to children, at a temperature from 2 °C to 8 °C. A period of validity - 3 years. After packaging opening drug can be stored at a temperature not above 25 °C. A period of validity after opening of a bottle - 1 month.

Issue conditions:

According to the recipe

Packaging:

5 ml - a bottle dropper polyethylene (1) - packs cardboard.