Fotil eye drops 20 mg + 5 mg / ml 5 ml (Pilocarpine, Timolol)

Latin name

FOTIL

Release form

Phot. Eye drops in the form of a clear, colorless solution.

Packaging

In a plastic dropper bottle, 5 ml eye drops. In packing 1 bottle dropper.

Pharmacological action

Combined anti-glaucoma drug.

Pilocarpine is an m-cholinomimetic, when applied topically, it reduces the smooth muscle of the circular muscle of the iris and ciliary muscle, which leads to an increase in the anterior chamber angle and a change in the configuration of the trabecular zone. This helps to increase the outflow of intraocular fluid from the anterior chamber of the eye and reduce intraocular pressure.

Timolol maleate - a beta-blocker, prevents the stimulating effect of catecholamines on -adrenoreceptors. Reduces intraocular pressure by reducing the formation of intraocular fluid.

Pilocarpine and timolol, when combined in the same drug, mutually reinforce the effect of each other.

When applied topically Fotil reduces and increased, and normal intraocular pressure, regardless of the presence of glaucoma. After a single dose of Photil is used, the intraocular pressure begins to decrease after 30 minutes, the maximum effect is usually achieved after 2 hours, the effect of the drug persists for 20 hours.

Pharmacokinetics

Timolol

Penetrates quickly through the cornea.

Reducing the formation of intraocular fluid, reduces the rate of excretion of pilocarpine from the eye.

Pilocarpine

Penetrates well through the cornea. C max in the intraocular fluid is reached after 30 minutes. Pilocarpine binds in most tissues of the eye, which extends its half-life from the eye, which is from 1.5 to 2.5 hours. Pilocarpine is excreted unchanged from the tissues of the eye along with intraocular fluid.

In plasma and liver, it quickly hydrolyzes to an inactive form. T 1/2 from blood plasma - less than 0.5 hours.

Indications

Open-angle and angle-angle glaucoma.

Glaucoma associated with aphakia.

Secondary glaucoma.

Increased intraocular pressure in the postoperative period.

Glaucoma after cataract surgery.

A marked increase in intraocular pressure with a risk of eye damage (including as part of combination anti-glaucoma therapy).

Contraindications

anterior uveitis

sinus bradycardia

AV block II and III degree

decompensated heart failure

cardiogenic shock

bronchial asthma

COPD and unrelated children with 18 years of age and years old children and adolescents)

condition immediately after ophthalmic surgery and other eye diseases in which pupil constriction is undesirable

hypersensitivity to the components of the preparations ata.

With caution, the drug should be prescribed for heart failure, cerebrovascular disorders, diabetes mellitus, hypoglycemia, retinal detachment, myopia, thyrotoxicosis, before surgery under general anesthesia.

Use during pregnancy and lactation

Until now, adequate and strictly controlled studies in pregnant women have not been conducted.

The use of Fotil during pregnancy and lactation is possible only if the intended benefits to the mother outweigh the potential risk to the fetus.

In experimental studies, no negative effect of timolol on fertility was detected.

There is currently no evidence that pilocarpine has teratogenic effects in glaucoma therapy in humans.

Composition

1 ml eye drops contains:

Active ingredients

Timolol maleate 6.84 mg.

Pilocarpine Hydrochloride 20 mg.

Excipients: benzalkonium chloride, citric acid, sodium citrate, hypromellose, water d / i.

Dosage and administration

Assign 1 drop of Photil to the affected eye 2 times / day.

In some patients, a stable decrease in intraocular pressure is achieved only after a few weekstherapy. Therefore, when evaluating the results of treatment, intraocular pressure should be measured approximately 4 weeks after the start of treatment. If the expected decrease in intraocular pressure does not occur, then Fotil forte should be prescribed (Fotil forte drops of ophthalmic fl.-cap. 5 ml cor. 1 Santen AO) or, given that a further increase in dose does not give an effect, combination therapy with carbonic anhydrase inhibitors for systemic use.

Before starting therapy with Photil, treatment with other anti-glaucoma eye drops should be discontinued the day before.

Side effects

Local reactions: blurred vision, eye irritation, rapidly passing burning sensation and pain in the eye, increased lacrimation, dry eye syndrome, eyelid dermatitis, conjunctival redness, ciliary muscle spasm and induced myopia, decreased visual acuity in low light ( due to myosis), a decrease in the sensitivity of the cornea, point keratitis, allergic blepharoconjunctivitis is very rare - diplopia and ptosis.

Several cases of retinal detachment, iris rigidity, or cyst formation in the iris have been noted in connection with the use of miotic agents. With prolonged use of pilocarpine, reversible lens opacification was observed.

Systemic reactions: nausea, diarrhea, increased sweating, increased salivation, decreased blood pressure, exacerbation of bronchial asthma, heart failure, bradycardia, arrhythmia, temporal and supraorbital headaches, skin rash.

Timolol crosses the BBB and has an effect on the central nervous system.

In all heart failure patients, timolol can cause asthenic syndrome, nausea, dizziness, anxiety, hallucinations, headache, and depression.

Nasal congestion was very rare.

Drug Interaction

When Fotil (which contains timolol) is used at the same time as beta-blockers for intake, there is an increase in the pharmacological action of beta-blockers.

With simultaneous use of the drug Fotil with calcium channel blockers of the verapamil type, violations of AV conduction, development of left ventricular failure, arterial hypotension are possible.

With the simultaneous use of Fotil with drugs that promote the release of catecholamines (for example, with reserpine), hypotension (including rtostatic hypotension), bradycardia, dizziness were observed in isolated cases.

Overdose

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

Treatment: carry out symptomatic therapy. Atropine can be used as an antidote to pilocarpine. The purpose of isoprenaline is shown for severe bradycardia, dobutamine bronchospasm - for hypotension of cardiac glycosides, diuretics - in case of acute heart failure.

Storage conditions

The drug should be stored at a temperature of 2 ° to 8 ° C. After opening the package, the drug can be stored at room temperature.

The Expiration of

is 3 years, after the bottle is opened - 1 month.

Deystvuyuschee substances

Pylokarpyn, Timolol

Dosage

dosage form

eye drops

Santen, France



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