Fotil forte drops glazn 40mg+5mg/ml 5ml fl-drops PE

Composition and release form

in plastic dropper bottles of 5 ml; 1 bottle in a box.

in plastic dropper bottles of 5 ml; 1 bottle in a box.

Pharmacodynamics

Pilocarpine, stimulating m-cholinergic receptors, reduces intraocular pressure by contracting the ciliary muscle and the muscle of the iris, which leads to a widening of the angle of the anterior chamber of the eye and changes the physical structure of the trabecular tissue, facilitating the outflow of aqueous humor (the effect lasts from 4 to 14 hours).

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

Pharmacokinetics

Pilocarpine penetrates well into the cornea, reaching Cmax in aqueous humor after 30 minutes. Bound by many tissues of the eye, T1/2 from the eye is from 1.5 to 2.5 hours. It is not metabolized in aqueous humor, being excreted along with it. Concomitant administration of timolol, which reduces the formation of intraocular fluid, reduces the rate of elimination of pilocarpine. It is rapidly hydrolyzed in the blood serum and in the liver to an inactive form. T1/2 from plasma - less than 30 minutes.

Timolol quickly penetrates the cornea. Intraocular pressure decreases 2 hours after topical application. The maximum effect is achieved after 4 hours, and the effect lasts for 10–20 hours.

Interactions

When co-administered with drugs that interfere with the deposition of catecholamines (reserpine), the likelihood of developing hypotension, orthostatic hypotension, bradycardia, and dizziness increases.

With simultaneous systemic use of beta blockers and calcium channel blockers (slow), the pharmacological effect may be enhanced and the risk of arrhythmia and hypotension may increase.

The drugs quinidine and cimetidine (CYP2D6 inhibitors) help increase the plasma levels of Timolol.

Contraindications

Hypersensitivity to any of the components of the drug, acute iritis, sinus bradycardia, AV block of II and III degrees, heart failure in the stage of decompensation, cardiogenic shock, bronchial asthma, severe chronic obstructive pulmonary diseases.

Use with caution in case of cerebrovascular disorders, heart failure, bronchial asthma, diabetes mellitus and hypoglycemia, thyrotoxicosis, before operations using general anesthesia.

Side effects

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

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

Overdose

The most serious manifestations of overdose associated with exposure to the active components of Fotil include: • severe bradycardia and hypotension; • bronchial obstruction due to spasm of smooth muscle cells; • acute heart failure.

Treatment measures are aimed at eliminating symptoms. Atropine is an antagonist of pilocarpine and can be used as an antidote. To eliminate the symptoms of overdose, isoprenaline (for broncho-obstruction and bronchospasm) and dobutamine (for decreased systemic pressure) can be used systemically.

Precautionary measures

Timolol penetrates the BBB and has an effect on the central nervous system, especially in overdose. Elderly patients with a history of heart failure may experience: asthenic syndrome, vomiting, dizziness, anxiety, hallucinations, headache and depression; less often - nasal congestion, diplopia, ptosis.

Several cases of retinal detachment, iris rigidity, or cyst formation in the iris have been reported in association with the use of miotic agents. Reversible lens opacification has been observed with long-term use of pilocarpine.

Symptoms of contact allergy and allergic dermatitis of the skin of the eyelids have been noted during therapy with drugs containing pilocarpine. Patients with hypersensitivity to timolol maleate may experience rashes, urticaria or allergic blepharoconjunctivitis.

The risk of developing tolerance with combined drops is less than when using drugs containing only one active substance.

Caution must be exercised when driving at night or in poor lighting.

Before instillation, contact lenses should be removed and reinserted 15 minutes after using the drug.

Safety and effectiveness in children have not been established.

Fotil forte drops glazn 40mg+5mg/ml 5ml fl-drops PE

Registration Certificate Holder

SANTEN (Finland)

Dosage form

Medicine - Fotil® Forte (Fotil® Forte)

Description

Eye drops

in the form of a clear, colorless solution.

1 ml

timolol maleate 6.84 mg, which corresponds to the content of timolol 5 mg pilocarpine hydrochloride 40 mg

Excipients

: benzalkonium chloride - 0.1 mg, citric acid - 0.88 mg, sodium citrate - 6.13 mg, hypromellose - 5 mg, liquid water - up to 1 ml.

5 ml - polyethylene dropper bottles (1) - cardboard packs.

Indications

Glaucoma or increased intraocular pressure, when a combination of timolol and pilocarpine is necessary:

• open-angle glaucoma;
• angle-closure glaucoma;
• secondary glaucoma;
• increased intraocular pressure after ophthalmic surgery.

Contraindications for use

• anterior uveitis;
• sinus bradycardia;
• AV block II and III degrees;
• decompensated heart failure;
• cardiogenic shock;
• bronchial asthma;
• COPD;
• children and adolescents under 18 years of age (due to the lack of data on the effectiveness and safety of the drug in children and adolescents);
• condition immediately after ophthalmological operations and other eye diseases in which constriction of the pupil is undesirable;
• hypersensitivity to the components of the drug.

Carefully _

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

pharmachologic effect

Combined antiglaucoma drug.
Pilocarpine
is an m-cholinomimetic. When instilled into the eye, pilocarpine causes miosis, spasm of accommodation and reduces intraocular pressure. The decrease in intraocular pressure is caused by contraction of the ciliary muscle and the muscle of the iris, which leads to a widening of the anterior chamber angle and changes the physical structure of the trabecular meshwork, facilitating the outflow of aqueous humor. This effect lasts from 4 hours to 14 hours.

Timolol

, being a beta-blocker, prevents the binding of sympathomimetic neurotransmitters to β1- and β2-adrenergic receptors in the ciliary body. Reduces intraocular pressure, reducing the production of aqueous humor. The hypotensive effect occurs 20 minutes after instillation, reaches a maximum after 2 hours and lasts about 24 hours.

Drug interactions

When used simultaneously with drugs that promote the release of catecholamines (for example, reserpine), arterial hypotension (including orthostatic), bradycardia, and dizziness were observed in isolated cases.

The simultaneous use of beta-blockers and systemic slow calcium channel blockers leads to an increase in their pharmacological effect and increases the risk of developing cardiac conduction disorders and arterial hypotension.

Inhibitors of the CYP2D6 isoenzyme, such as quinidine and cimetidine, may increase plasma concentrations of timolol.

Dosage regimen

The drug is prescribed 1 drop into the affected eye 2 times a day.

In some patients, a stable decrease in intraocular pressure caused by the use of Fotil® is achieved only after several weeks of therapy. Therefore, when assessing 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 during treatment with Fotil® eye drops, it is recommended to continue treatment with Fotil® Forte eye drops, 1 drop 2 times a day.

Overdose

Symptoms:

bradycardia, decreased blood pressure, bronchospasm, acute heart failure.

Treatment:

carry out symptomatic therapy. Atropine can be used as an antidote for pilocarpine. IV isoprenaline is indicated for severe bradycardia and bronchospasm; dobutamine - for arterial hypotension.

Side effect

Local reactions:

blurred vision, eye irritation, quickly passing burning sensation and pain in the eye, increased lacrimation, dry eye syndrome, eyelid dermatitis, redness of the conjunctiva, spasm of the ciliary muscle and induced myopia, decreased visual acuity in low light (due to miosis), decreased sensitivity of the cornea, punctate keratitis, allergic blepharoconjunctivitis; very rarely - diplopia, ptosis.

Several cases of retinal detachment, iris rigidity, or cyst formation in the iris have been reported in association with the use of miotic agents. With long-term use of pilocarpine, reversible clouding of the lens has been 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.

Nasal congestion was very rarely observed.

special instructions

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

The use of other eye drops should be discontinued before therapy with Fotil® forte is started. The previous antiglaucoma drug should be discontinued, and therapy with Fotil® forte eye drops should be started the next day.

The effectiveness of the drug should be assessed 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® forte eye drops contain benzalkonium chloride as a preservative and are not recommended for use when wearing contact lenses. Before using the drug, you should remove contact lenses and reinsert 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 upcoming surgery under general anesthesia, it is necessary to discontinue Fotil® Forte 48 hours before surgery, because
the drug enhances the effect of muscle relaxants and general anesthetics. Effect on the ability to drive vehicles and machinery
The miotic effect can cause a transient deterioration of vision (a feeling of myopia), therefore, during the treatment period, care must be taken when driving a vehicle or operating any complex equipment that requires increased concentration and speed of psychomotor reactions.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 2° to 8°C.

Best before date

Shelf life: 3 years.

After opening the package, the drug can be stored at a temperature not exceeding 25°C. Shelf life after opening the bottle is 1 month.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution. The use of Fotil® forte during pregnancy and breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the fetus and child.

Use in children

Restrictions for children - Contraindicated.

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).

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

SANTEN LLC (Russia)

105064 Moscow Nizhny Susalny lane. 5, p. 19, office. 402 Tel.

special instructions

Should not be used simultaneously with other drugs containing beta-blockers.

The use of other eye drops should be discontinued before starting treatment with the drug. The previous antiglaucoma drug must be discontinued, and therapy with Fotil eye drops should be started the next day. Evaluation of the effectiveness of treatment should be carried out 4 weeks after the start of treatment (in some patients, tolerance may develop after a few weeks).

Treatment should be carried out with regular monitoring of intraocular pressure.

Mode of application

The standard dosage is one drop twice a day in the affected eye only. Sometimes long-term use of Fotil is required (for several weeks) for the patient to sustainably reduce intraocular pressure. In this regard, it is necessary to carry out an objective assessment of intraocular hypertension by measuring pressure approximately one month after the start of therapy. In cases where intraocular hypertension is detected during manometry, it is recommended to replace the drug Fotil with Fotil Forte, which is more effective. It should be used in the same way as in the case of the non-extended form (1 drop 2 times a day).