Instruction for use: Fotil

Active substance: Pilocarpine + Timolol

ATX Code S01EB51 pilocarpine in combination with other drugs

Pharmacotherapeutic group:

Beta-blockers in combination

m-Holinomimetiki in combinations

Ophthalmic agents in combination

The nosological classification (ICD-10)

H40.0 Suspected glaucoma

Marked rise in intraocular pressure, Hypertension eyes, ocular hypertension, Measurement of intraocular pressure, ophthalmohypertension, Elevated IOP, Elevated intraocular pressure, Elevated intraocular pressure in infectious diseases of the eye, Povyshennore intraocular pressure, Increased ophthalmotonus, Spontaneous blockade angle opposite eye, Narrow chamber angle, Iatrogenic, blockade angle opposite eye

H40.1 Primary open-angle glaucoma

open-angle glaucoma, Open-angle glaucoma, Primary glaucoma, pseudoexfoliation glaucoma, Elevated IOP

H40.2 Primary angle-closure glaucoma

closure Glaucoma, Glaucoma with a narrow angle of anterior chamber, Angle-closure glaucoma, Acute angle-closure glaucoma, An acute attack of angle-closure glaucoma, Elevated intraocular pressure angle-closure glaucoma, Chronic angle-closure glaucoma

H40.3 Glaucoma secondary posttraumatic

Post-traumatic secondary glaucoma, Glaucoma after cataract operated

H40.4 Glaucoma secondary to inflammatory diseases of the eye

Glaucoma uveal, Uveal secondary glaucoma

H40.5 Glaucoma secondary to other eye diseases

The secondary open-angle glaucoma, Glaucoma afakicheskaya, Secondary glaucoma

Composition

Eye drops 1 ml

pilocarpine hydrochloride 20 mg

Timolol maleate (equivalent to Timolol) 5 mg

Excipients: benzalkonium chloride - 0.1 mg; Citric acid (monohydrate); sodium citrate; Valium; water for injections

in plastic vials looks to 5 ml; in box 1 bottle.

Eye drops 1 ml

pilocarpine hydrochloride 40 mg

Timolol maleate (equivalent to Timolol) 5 mg

Excipients: benzalkonium chloride - 0.1 mg; Citric acid (monohydrate); sodium citrate; Valium; water for injections

in plastic vials looks to 5 ml; in box 1 bottle.

The drug forms

Transparent, slightly bitter, watery, colorless, odorless liquid.

pharmachologic effect

antiglaucoma.

Timolol blocks beta-adrenergic receptors and reduces the production of intraocular fluid.

Pilocarpine stimulates m-cholinergic receptors, improves the outflow of intraocular fluid.

pharmacodynamics

Pilocarpine to stimulate m-cholinergic receptors, reduces intraocular pressure by reducing the ciliary muscles and the muscles of the iris, which leads to the expansion of the anterior chamber angle and changes the physical structure of the trabecular tissue, facilitating the outflow of the aqueous humor (the effect lasts from 4 to 14 hours).

Timolol prevents binding sympathomimetic neurotransmitters with beta2-adrenergic receptors in the ciliary body, decreases the production of aqueous humor, reducing the intraocular pressure.

Pharmacokinetics

Pilocarpine well penetrates into the cornea, reaching Cmax in the aqueous humor at 30 minutes. Associated many tissues of the eye, the T1 / 2 of the eye is 1.5 to 2.5 hours. Do not metabolized in the aqueous humor, standing with her. Concomitant administration of timolol, which reduces the formation of intraocular fluid, reduces the rate of elimination of pilocarpine. Rapidly hydrolyzed in blood serum and liver to inactive forms. T1 / 2 of plasma - less than 30 minutes.

Timolol rapidly penetrates the cornea. Intraocular pressure is decreased at 2 hours after topical application. The maximum effect is achieved after 4 hours and the effect lasts for 10-20 hours.

Indications

Open-and angle-closure glaucoma, glaucoma with aphakia, secondary glaucoma, a pronounced rise in intraocular pressure (in combination with other drugs), increased intraocular pressure after surgery on an eye.

Contraindications

Hypersensitivity to any component of the medication, acute iritis, sinus bradycardia, AV block II and III degree, heart failure decompensation, cardiogenic shock, bronchial asthma, chronic obstructive pulmonary disease in a severe form.

Be wary of cerebrovascular disorders, heart failure, asthma, diabetes and hypoglycemia, hyperthyroidism, before operations with the use of general anesthesia.

Pregnancy and breast-feeding

The drug should not be used during pregnancy and lactation if the expected therapeutic effect is less than the potential risk to the fetus.

Side effects

Local: quickly passing a burning sensation and pain in the eye, increased lacrimation, conjunctival redness, and Supraorbital temporal headaches, myopia; associated with timolol: decreased corneal sensitivity, punctate keratitis, "dry eye" syndrome, dermatitis century; possible: a spasm of the ciliary muscle, induced myopia, reduced visual acuity in low light (due to miosis).

System: nausea, diarrhea, sweating, increased salivation, decreased blood pressure, asthma attack, heart failure, arrhythmia.

Interaction

Drugs that violate deposit catecholamines (reserpine) contribute to the development of arterial hypotension (including orthostatic), bradycardia, and dizziness.

Concomitant use of beta-blockers for systemic effects leads to a strengthening of their pharmacological effect.

Dosing and Administration

Kongungualno. 1 drop into the affected eye two times a day.

If the usual dosage intraocular pressure is elevated, it can be increased by: 1 drop Fotil forte 2 times per day.

Overdose

Symptoms: bradycardia, decreased blood pressure, bronchospasm and acute cardiac insufficiency.

Treatment: symptomatic; atropine - like antidote pilocarpine, isoprenaline - I / O, to eliminate severe bradycardia or bronchospasm, dobutamine - for the treatment of arterial hypotension.

Precautionary measures

Timolol penetrate the BBB and affects the central nervous system, especially in overdose. In elderly patients with heart failure, a history can be observed: asthenic syndrome, vomiting, dizziness, anxiety, hallucinations, headache, and depression; at least - nasal congestion, diplopia, ptosis.

Several cases of retinal detachment, or stiffness of the iris cyst formation in the iris of the eye have been reported in connection with the use of miotics. Reversible cataract was observed after prolonged use of pilocarpine.

Symptoms of allergic contact dermatitis and allergic skin age were noted in the treatment with drugs containing pilocarpine. In patients with hypersensitivity to timolol maleate may appear rash, urticaria, or allergic Blepharoconjunctivitis.

The risk of tolerance in the combined droplet is smaller than with preparations containing only one active substance.

Be careful when driving at night or in low light.

Before instillation contact lenses should be removed and re-install them 15 min after the drug.

Safety and efficacy in children has not been established.

special instructions

It must not be used concomitantly with other drugs containing beta-blockers.

Using other eye drops should be discontinued prior to drug treatment. Previous glaucoma means you want to cancel, and the treatment of eye drops Fotil start the next day. Evaluation of the effectiveness of treatment should be performed at 4 weeks after initiation of treatment (some patients a few weeks may develop tolerance).

Treatment carried out at regular monitoring of intraocular pressure.

Storage conditions

At a temperature of 2-8 ° C. Opened vials - at room t (below 25 ° C), protected from light.

Keep out of the reach of children.

shelf life

3 years. After opening the bottle - 1 month.

Do not use beyond the expiration date printed on the package.