Fotil drops 5ml

Fotil instruction for use

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Composition

    1 ml of eye drops contains:
    Active substances
    Timolol maleate 6.84 mg.
    Pilocarpine hydrochloride 20 mg.
    Excipients: benzalkonium chloride, citric acid, sodium citrate, hypromellose, water d / and.

Packaging

In a dropper of plastic 5 ml drops of the eye. In the package 1 bottle-dropper.

pharmachologic effect

Combined antiglaucoma preparation.
Pilocarpine is an m-holinomimetic, with topical application it reduces the smooth muscles of the circular muscle of the iris and ciliary muscle, which leads to an increase in the angle of the anterior chamber of the eye, 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 decrease the intraocular pressure.
Timolola maleate - beta-blocker, prevents the stimulating effect of catecholamines on β-adrenergic receptors. Reduces intraocular pressure by reducing the formation of intraocular fluid.
Pilocarpine and timolol with a combination in one preparation mutually reinforce each other.
With topical application, Fotil reduces both increased and normal intraocular pressure, irrespective of the presence of glaucoma. After a single application of a single dose of Fotil, intraocular pressure begins to decrease after 30 minutes, the maximum effect is usually achieved after 2 hours, the effect of the drug is maintained for 20 hours.

Pharmacokinetics

Timolol
Rapidly penetrates through the cornea.
Reducing the formation of intraocular fluid, reduces the rate of excretion of pilocarpine from the eye.
Pilocarpine
Well penetrates through the cornea. C max in the intraocular fluid is achieved after 30 min. Pilocarpine binds in most tissues of the eye, which prolongs its half-life from the eye, which ranges from 1.5 to 2.5 hours. Pilocarpine is unchanged from the eye tissues along with the intraocular fluid.
In blood plasma and liver quickly hydrolyzed into an inactive form. T 1/2 from blood plasma - less than 0.5 h.

Fotil, indications for use

    Open angle and angle-closure glaucoma.
    Glaucoma associated with aphakia.
    Secondary glaucoma.
    Increase in intraocular pressure in the postoperative period.
    Glaucoma after surgery for cataracts.
    Pronounced increase in intraocular pressure with risk of eye damage (including as part of combined antiglaucoma therapy).

Contraindications for Fotil

    anterior uveitis;
    sinus bradycardia;
    AV blockade II and III degree;
    Decompensated heart failure;
    cardiogenic shock;
    bronchial asthma;
    COPD;
    children and adolescents under 18 years (due to the lack of data on the effectiveness and safety of the drug in children and adolescents);
    the condition immediately after ophthalmic operations and other eye diseases, in which the narrowing of the pupil is undesirable;
    hypersensitivity to the components of the drug.
With caution should prescribe the drug for heart failure, cerebrovascular disorders, diabetes, hypoglycemia, retinal detachment, myopia, thyrotoxicosis, before surgery under general anesthesia.

Dosing and Administration

Assign 1 drop of the drug Fotil to the affected eye 2 times / day.
In some patients, stable decrease in intraocular pressure is achieved only after several weeks of therapy. Therefore, when evaluating the results of treatment, it is necessary to measure the intraocular pressure approximately 4 weeks after the start of treatment. If the expected decrease in intraocular pressure does not occur, Fotil forte should be prescribed (Fotil forte drops drops of ophthalmic 5 ml capsule 1 Santen AO) or, in view of the fact that further increasing of the dose does not give effect, combined therapy with inhibitors of carbonic anhydrase for systemic use.
Before starting therapy with Fotil, treatment with other antiglaucoma eye drops should be discontinued the day before.

Application Fotil in pregnancy and lactation

To date, adequate and strictly controlled studies have not been conducted in pregnant women.
The use of Fotil during pregnancy and during lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.
In experimental studies, there was no adverse effect of timolol on fertility.
At present, there is no evidence that pilocarpine has a teratogenic effect in the treatment of glaucoma in humans.

Side effects of Fotil

Local reactions: blurred vision, eye irritation, rapid burning sensation and pain in the eye, increased lacrimation, dry eye syndrome, dermatitis of the eyelids, redness of the conjunctiva, ciliary muscle spasm and induced myopia, reduced visual acuity in poor lighting (due to miosis), decreased sensitivity of the cornea, point keratitis, allergic blepharoconjunctivitis; very rarely - diplopia and ptosis.
Several cases of retinal detachment, iris rigidity, or cyst formation in the iris were noted in connection with the use of miotic agents. With prolonged use of pilocarpine, reversible opacification of the lens 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 penetrates the BBB and has an effect on the central nervous system.
In all patients with heart failure, timolol can cause asthenic syndrome, nausea, dizziness, anxiety, hallucinations, headache and depression.
Very rarely there was a stuffy nose.

special instructions

The drug is prescribed for patients who can not compensate for increased intraocular pressure with monotherapy, in almost all forms of glaucoma.
Caution should be given to the drug in the following cases:
    Patients with cerebrovascular disorders.
    With hypoglycemia.
    Before the operation under anesthesia.
Care should be taken when prescribing the drug to patients receiving beta-blockers inwards.
With prolonged use of Fotil in patients with glaucoma may develop resistance to the active components of the drug. However, to the combined eye drops the degree of development of tolerance is expressed less than to monocomponent antiglaucoma drugs.
Evaluation of the effectiveness of the drug should be carried out approximately 4 weeks after the start of treatment. Measurement of intraocular pressure should be carried out at different times of the day.
Due to the fact that the preparation contains a preservative, patients wearing soft contact lenses should be removed before using drops. It is recommended that you wait 15 minutes before reinserting contact lenses.
During the period of drug use, dark adaptation may worsen. The patient should be warned about the danger of movement in the dark.

Use in Pediatrics

Clinical trials of the safety and efficacy of the use of Fotil in children have not been conducted.

Results of experimental studies

In studies carried out on laboratory animals, there was no mutagenic effect of timolol.
At present, there is no evidence that pilocarpine has a mutagenic effect in the treatment of glaucoma in humans. However, in experimental studies, signs of mutagenicity in pilocarpine have been identified.
Impact on the ability to drive vehicles and manage mechanisms
Drivers of vehicles must be careful when driving in conditions of insufficient lighting, because the drug can disrupt the dark adaptation.

Drug Interactions

With the use of Fotil (which includes timolol), simultaneous with beta-adrenoblockers for oral administration, the pharmacological effect of beta-blockers is increasing.
With the simultaneous use of the drug Fotil with calcium channel blockers such as verapamil, AV-conduction disorders, 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), in a few cases, hypotension (including rstostatic hypotension), bradycardia, dizziness was observed.

Overdose

    Symptoms: bradycardia, arterial hypotension, bronchospasm, acute heart failure.
    Treatment: conduct symptomatic therapy. Atropine can be used as an antidote for pilocarpine. The appointment of isoprenaline with pronounced bradycardia, bronchospasm; dobutamine - with hypotension; cardiac glycosides, diuretics - in case of acute cardiac insufficiency.

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.
Shelf life - 3 years, after opening the bottle - 1 month.

What helps Fotil

H40.0 Glaucoma suspected, H40.1 Primary open angle glaucoma, H40.2 Primary angle-closure glaucoma, H40.3 Secondary post-traumatic glaucoma, H40.4 Secondary glaucoma due to inflammatory eye disease, H40.5 Glaucoma secondary due to other eye diseases