Fotil eye drops 20mg+5mg/ml, 5ml

Composition

Eye drops in the form of a clear colorless solution.

1 ml of timolol maleate 6.84 mg, which corresponds to the content of timolol 5 mg

pilocarpine hydrochloride 20 mg

Auxiliary substances:

benzalkonium chloride,

citric acid,

sodium citrate,

hypromellose,

d/i water.

Pharmacological action

The combined preparation contains two active ingredients. Pilocarpine in the form of eye drops causes a narrowing of the pupil and a spasm of accommodation, and also lowers intraocular pressure by contracting the ciliary muscle and the iris muscle, which facilitates the outflow of watery moisture from the anterior chamber of the eye. The effect of pilocarpine occurs in 30 minutes and lasts 4-14 hours, with a half-life of 1.5 to 2.5 hours. The substance is not metabolized, it is excreted with watery moisture.

Timolol is a beta-blocker that reduces intraocular pressure and reduces the production of watery moisture by the visual organ. It acts mainly on the ciliary body. Slows down the process of removing pilocarpine with watery moisture. Its half-life is less than 30 minutes. Reduces intraocular pressure 2 hours after instillation in the eyes. The maximum effect should be expected in 4 hours, the action lasts from 10 to 20 hours.

Pilocarpine and timolol, when combined in one drug, mutually enhance the effect of each other.

When applied topically, Fotil reduces both elevated and normal intraocular pressure, regardless 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 persists for 20 hours.

Pharmacokinetics

Timolol

Penetrates quickly through the cornea.

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

Pilocarpine

Penetrates well through the cornea. Cmax in the intraocular fluid is reached after 30 minutes. Pilocarpine binds in most eye tissues, which prolongs its half-life from the eye, which is from 1.5 to 2.5 hours. Pilocarpine in unchanged form is removed from the eye tissues along with intraocular fluid. In the blood plasma and liver, it is rapidly hydrolyzed to an inactive form. T 1/2 from blood plasma-less than 0.5 h.

Indications

• Open-angle and closed-angle glaucoma.
• Glaucoma associated with aphakia.
• Glaucoma after cataract surgery.
• Secondary glaucoma.
• Increased intraocular pressure in the postoperative period.
• Marked increase in intraocular pressure with a risk of eye damage (including as part of combined anti-glaucoma therapy).

Use during pregnancy and lactation

 The use of Fotil during pregnancy and lactation is only possible if the intended benefit to the mother exceeds the potential risk to the fetus or child.

 Use in children

Contraindication: children under 18 years of age (due to the lack of data on the effectiveness and safety of the drug in children and adolescents under 18 years of age).

Contraindications

• Hypersensitivity to the components of the drug.
• Acute iritis.
• Bronchial asthma (including in the anamnesis).
• Acute or chronic obstructive pulmonary diseases.
• Sinus bradycardia.
• AV blockage of II and III degrees.
• Heart failure.
• Cardiogenic shock.

With caution, it is prescribed for hypoglycemia, cerebrovascular disorders, heart failure, diabetes mellitus, thyrotoxicosis, cerebrovascular disorders, as well as before surgery, in which general anesthesia is planned.

Side effects

Local reactions caused by pilocarpine

Rapidly passing burning sensation and pain, ciliary muscle spasm, conjunctival hyperemia, induced myopia (these reactions are more often observed in young people at the beginning of treatment). Due to miosis, visual acuity may decrease in low light conditions. Rarely-rigidity of the iris, iris cyst, retinal detachment; with prolonged use in some cases-reversible opacity of the lens.

Local reactions due to timolol maleate

Corneal anesthesia, spot keratitis, dry eye syndrome, allergic blepharoconjunctivitis and eyelid dermatitis.

Systemic effects due to pilocarpine (rare)

Nausea, vomiting, diarrhea, increased sweating and salivation, hypotension, headache, asthenia; hyperemia of the nasal mucosa.

Systemic effects due to timolol maleate (extremely rare)

Violations of airway patency up to the development of bronchospasm, the phenomenon of chronic heart failure, arrhythmia, hallucinations, confusion.

Interaction

 Arterial hypotension (including orthostatic hypotension), bradycardia, and dizziness were observed when Photil was co-administered with drugs that promote the release of catecholamines (for example, reserpine).

Simultaneous use of beta-blockers and systemic slow calcium channel blockers increases their pharmacological effect and increases the risk of cardiac conduction disorders and arterial hypotension.

Inhibitors of the CYP2D6 isoenzyme, such as quinidine and cimetidine, can increase the concentration of timolol in plasma.

How to take, course of use and dosage

Assign 1 drop to the affected eye 2 times a day.

In some patients, a stable decrease in intraocular pressure is achieved only after a few weeks of therapy.

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 1 drop 2 times a day.

Overdose

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

Treatment: perform symptomatic therapy.

Atropine can be used as an antidote to pilocarpine.

Isoprenaline is indicated for severe bradycardia, bronchospasm; dobutamine-for hypotension; cardiac glycosides, diuretics-for acute heart failure.

Special instructions

Fotil eye drops should not be used simultaneously with other eye drops containing beta-blockers.

The use of other eye drops should be discontinued before starting therapy with Fotil. The previous anti-glaucoma drug should be discontinued, and therapy with Fotil eye drops should be started the next day.

Evaluation of the effectiveness of the drug should be carried out 4 weeks after the start of treatment with regular monitoring of intraocular pressure.

Further treatment should also be carried out with regular monitoring of intraocular pressure.

Fotil eye drops contain benzalkonium chloride as a preservative, and they are not recommended for use when wearing contact lenses. Before using the drug, remove contact lenses and re-install them no earlier than 15 minutes after instillation of the drug.

Timolol, which is part of the drug, can mask the symptoms of hypoglycemia in patients with diabetes mellitus or symptoms of hyperthyroidism.

In case of an upcoming surgical intervention under general anesthesia, it is necessary to cancel Fotil® 48 hours before the operation, since the drug enhances the effect of muscle relaxants and general anesthetics.

Influence on the ability to drive motor vehicles and manage mechanisms

The myotic effect can cause temporary visual impairment (a feeling of nearsightedness), so during treatment, care should be taken when driving vehicles or operating any complex equipment that requires increased concentration of attention and speed of psychomotor reactions.

Form of production

Fotil. Eye drops.

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

Active ingredient

Pilocarpine, Timolol

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor, For Nursing mothers as prescribed by a doctor

Indications

Glaucoma