Universal reference book for medicines
Product name: FOTIL® FORTE

Active substance: pilocarpine, timolol

Type: Antiglaucoma preparation

Manufacturer: SANTEN (Finland)
Composition, form of production and packaging
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, water d / and - up to 1 ml.

5 ml - a bottle-droppers polyethylene (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Combined antiglaucoma preparation.

Pilocarpine - m-cholinomimetic.
When instilled in the eye pilocarpin causes miosis, spasm of accommodation and reduces intraocular pressure. Decrease in intraocular pressure is due to the reduction of ciliary muscle and the muscle of the iris, which leads to an expansion of the angle of the anterior chamber of the eye and changes the physical structure of the trabecular network, facilitating the outflow of aqueous humor. This effect lasts from 4 hours to 14 hours.
Timolol, being a beta-adrenoblocker, prevents the binding of sympathomimetic neurotransmitters with?
1 - and? 2- adrenoreceptors in the ciliary body. Reduces intraocular pressure, reducing the production of watery moisture. The hypotensive effect occurs 20 minutes after instillation, reaches a maximum after 2 hours and lasts about 24 hours.
PHARMACOKINETICS

Pilocarpine penetrates well through the cornea.
Concentration in watery moisture reaches its maximum after 30 minutes. Pilocarpine is bound by many tissues of the eye. T 1/2 of the eye is 1.5-2.5 hours. Pilocarpine is excreted unchanged with intraocular fluid.
Combining it with timolol, which reduces the formation of watery moisture, slows the rate of excretion of pilocarpine.

Pilocarpine is rapidly hydrolyzed to inactive forms in blood plasma and liver.
T 1/2 is less than 0.5 h.
Timolol quickly penetrates through the cornea into the watery moisture of the anterior chamber of the eye.
About 80% of locally applied timolol penetrates the systemic circulation. C max in blood plasma is determined approximately 1 hour after the installation of eye drops.
Metabolized, mainly in the liver.
T 1/2 is 2-5 hours. It is excreted mainly through the kidneys.
INDICATIONS

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

- open-angle glaucoma;

- an angle-closure glaucoma;

- secondary glaucoma;

- increased intraocular pressure after ophthalmic operations.

DOSING MODE

Assign 1 drop to the affected eye 2 times / day.
In some patients, a stable decrease in intraocular pressure caused by the use of the drug Fotil ® is achieved only after several weeks of therapy. Therefore, when evaluating the results of treatment, the 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 eye drops of Fotil ® , then continue treatment with eye drops Fotil ®forte 1 drop 2 times / day.
SIDE EFFECT

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, 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.

CONTRAINDICATIONS

- Anterior uveitis;

- sinus bradycardia;

- AV blockade II and III degree;

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);

- 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.

PREGNANCY AND LACTATION

The use of the drug Fotil ® forte during pregnancy and during breastfeeding is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

APPLICATION FOR 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).

SPECIAL INSTRUCTIONS

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

Use of other eye drops should be discontinued before therapy with Fotil ® forte is started.
Previous antiglaucoma drug should be canceled, and therapy with eye drops Fotil ® forte start the next day.
Evaluation of the effectiveness of the drug should be conducted 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.

Fotyl ® forte eye drops contain benzalkonium chloride as a preservative, and they are not recommended for use with contact lenses.
Before using the drug, contact lenses should be removed and reinserted no earlier than 15 minutes after the instillation of the drug.
Timolol, which is part of the drug, can mask symptoms of hypoglycemia in patients with diabetes mellitus or symptoms of hyperthyroidism.

In case of the upcoming surgery under general anesthesia, it is necessary to cancel Fotil ® forte 48 hours prior to surgery, because
the drug enhances the effect of muscle relaxants and general anesthetics.
Impact on the ability to drive vehicles and manage mechanisms

The miotic effect can cause transient deterioration of vision (sensation of nearsightedness), therefore during the period of treatment it is necessary to be careful when driving vehicles or operating any complex equipment that requires an increased concentration of attention and speed of psychomotor reactions.

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 in / in the presence of severe bradycardia, bronchospasm; dobutamine - with arterial hypotension.
DRUG INTERACTION

With the simultaneous use of Fotila fort with drugs that promote the release of catecholamines (for example, with reserpine), in a few cases, arterial hypotension (including orthostatic), bradycardia, dizziness.

Simultaneous application of beta-adrenoblockers and blockers of slow calcium channels of systemic action leads to an increase in their pharmacological effect and increases the risk of cardiac conduction and arterial hypotension.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children at a temperature of 2 ° to 8 ° C.
Shelf life - 3 years.
After opening the package, the drug can be stored at a temperature of no higher than 25 ° C.
Shelf life after bottle opening - 1 month.
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