Fotil® (Fotil®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePilocarpine + TimololPilocarpine + Timolol
Dosage form: & nbspEye Drops

Composition:1 ml of the preparation contains:
Active substances:
Pilocarpine hydrochloride 20.0 mg, timolol maleate 6.84 mg (equivalent to timolol 5.0 mg)
Excipients:
Benzalkonium chloride 0.10 mg, citric acid 1.12 mg, sodium citrate 5.79 mg, hypromellose 5.0 mg, water for injection up to 1.0 ml.

Description:A clear, colorless solution.

Pharmacotherapeutic group:Antiglaucoma means combined (m-cholinomimetic and beta-adrenoblocker)
ATX: & nbsp

S.01.E.B.51   Pilocarpine in combination with other drugs

Pharmacodynamics:Eye drops Fotil® contain two active substances. Pilocarpine is parasympatomimetikbm, which stimulates m-cholinergic receptors. When instilled in the eye pilocarpine causes miosis, spasm of accommodation and reduces intraocular pressure. Decrease in intraocular pressure is caused by reduction of ciliary muscle and 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 to 14 hours.
Timolol, being a beta-adrenoblocker, prevents the binding of sympathomimetic neurotransmitters with beta1- and beta2-adrenergic receptors. It reduces intraocular pressure, reducing the production of watery moisture. Targets of action timolol - beta2-adrenergic receptors in the ciliary body. The hypotensive effect occurs 20 minutes after instillation, reaches a maximum after 2 hours and lasts about 24 hours.

Pharmacokinetics:Pilocarpine well penetrates through the cornea. Concentration in watery moisture reaches its maximum after 30 minutes. Pilocarpine binds many tissues of the eye. The half-life of the eye is 1.5 - 2.5 hours. Pilocarpine is displayed unchanged with the 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.The half-life is less than 0.5 hour.
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. The maximum concentration (Сmах) in blood plasma is determined approximately 1 hour after instillation of eye drops. The half-life is 2-5 hours. Metabolized, mainly in the liver. It is excreted mainly through the kidneys.


Indications:Glaucoma or increased intraocular pressure, when a combination of timolol and pilocarpine is necessary:
- open-angle and angle-closure glaucoma;
- secondary glaucoma;
- increased intraocular pressure after ophthalmic operations.

Contraindications:- Anterior uveitis;
- sinus bradycardia;
- atrioventricular blockade of II-III degree; . ,
Decompensated heart failure;
- cardiogenic shock;
- bronchial asthma;
- chronic obstructive pulmonary disease;
- Children's age under 18 years (due to the lack of data on the efficacy and safety of the drug in children and adolescents under 18 years);
- hypersensitivity to any of the components of the drug;
- the condition immediately after ophthalmic operations and other eye diseases, in which the narrowing of the pupil is undesirable.

Carefully:With heart failure, cerebrovascular disorders, diabetes, hypoglycemia, retinal detachment, in patients with myopia, thyrotoxicosis and before surgery under general anesthesia.

Pregnancy and lactation:Fotil® eye drops can be used during pregnancy and during breastfeeding, unless the expected therapeutic effect for the mother justifies the potential risk to the fetus or the baby.

Dosing and Administration:The usual dosage is 1 drop in the affected eye 2 times a day. In some patients, a sustained reduction in intraocular pressure caused by Fotil® is achieved only after a few weeks, so the evaluation of therapy should include measuring the intraocular pressure approximately 4 weeks after the start of treatment. If the intraocular pressure of the patient remains elevated in the treatment with eye drops Fotil®, it is recommended to continue treatment with eye drops Fotil® forte, 1 drop 2 times a day.

Side effects:From the side of the eye:
- blurred vision;
- Irritation of the eye;
- a rapid burning sensation and pain in the eye;
- increased lachrymation;
- dry eye syndrome;
- Dermatitis of the eyelids;
reddening of the conjunctiva;
- ciliary muscle spasm and induced myopia;
- reduced visual acuity in case of insufficient illumination (due to miosis);
- decreased sensitivity of the cornea;
- Point keratitis;
allergic blepharoconjunctivitis.
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.
System:
Nausea, diarrhea, sweating, increased salivation and lower blood pressure, exacerbation of bronchial asthma, heart failure, bradycardia and arrhythmia, temporal and supraorbital headaches, rashes on the skin, hives.
Timolol penetrates the blood-brain barrier and affects the central nervous system.
In all patients with heart failure, it can cause asthenic syndrome, nausea, dizziness, anxiety, hallucinations, headache and depression.
Very rarely - nasal congestion, diplopia and ptosis.

Overdose:The most common symptoms caused by overdose of parasympatomimetic drugs and beta-blockers: bradycardia, lowering of blood pressure, bronchospasm and acute heart failure.

Treatment is mostly symptomatic. Atropine can be used as an antidote for pilocarpine. Isoprenaline can be administered intravenously to eliminate severe bradycardia or bronchospasm, dobutamine for the treatment of arterial hypotension.

Interaction:Drugs that disrupt the deposition of catecholamines (reserpine) contribute to the development of arterial hypotension (including orthostatic), bradycardia and dizziness.
Simultaneous use 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.
CYP2D6 inhibitors, such as quinidine and cimetidine, can increase the concentration of timolol in the plasma.

Special instructions:Eye drops Fotil® should not be used concomitantly with other eye drops containing beta-blockers.
The use of other eye drops should be discontinued before therapy with Fotil® is started: the previous antiglaucoma agent should be discontinued and therapy with Fotyl® eye drops should be started the next day.
Evaluation of the effectiveness of the action should be carried out 4 weeks after the start of treatment with regular monitoring of intraocular pressure.
Further treatment should also be carried out under regular monitoring of intraocular pressure.
Eye drops Fotil® contain as a preservative benzalkonium chloride and they are not recommended for use with contact lenses. Before using the drug, contact lenses should be removed and reinstalled no earlier than 15 minutes.
Timolol, which is part of the drug, can hide the symptoms of hypoglycemia in patients with diabetes mellitus or symptoms of thyroid hyperfunction.
In case of the upcoming surgery under general anesthesia, it is necessary to cancel the drug 48 hours before the surgery, as it increases the effect of muscle relaxants and general anesthetics.

Effect on the ability to drive transp. cf. and fur:The myotonic effect can cause transient visual impairment (sensation of nearsightedness), therefore, during the treatment period, care must be taken when driving vehicles or operating any complex equipment that requires an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Fotil®, eye drops 20 mg / ml + 5 mg / ml.

Packaging:To 5 ml in a plastic bottle-dropper, ukuporenny plastic cap with a screw cap. The bottle-dropper along with the instruction for use is placed in a cardboard pack.

Storage conditions:Store at a temperature of 2 to 8 ° C.
The open vial is stored at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:3 years. After opening the bottle - 1 month.
Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N015324 / 01
Date of registration:11.12.2008
The owner of the registration certificate: Santen, AO Santen, AO Finland
Manufacturer: & nbsp
Representation: & nbspSANTEN AS SANTEN AS Finland
Information update date: & nbsp17.02.2015
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