FOTIL FORTE EYE DROPS 5ML

Dosage form

Eye drops

Composition

1 ml of eye drops contains: Timolol maleate 6.84 mg, pilocarpine hydrochloride 40 mg.

Packing

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

Mechanism of action

Fotil forte is a combined antiglaucoma drug.
Pilocarpine - m-cholinomimetic, when applied topically causes a reduction in 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, changing the configuration of the trabecular zone. This helps to increase the outflow of intraocular fluid from the anterior chamber of the eye and reduce intraocular pressure.
Timolol maleate, a beta-blocker, prevents the stimulating effect of catecholamines on β-adrenoreceptors. Reduces intraocular pressure by reducing the formation of intraocular fluid.
Pilocarpine and timolol, when combined in the same preparation, mutually reinforce each other's effects.
When applied topically, Fotil reduces both elevated and normal intraocular pressure without regard to the presence of glaucoma. After a single dose of the drug 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.

Indications and usage

- Open-angle and angle-closure glaucoma.
- Glaucoma associated with aphakia.
- Secondary glaucoma.
- Increased intraocular pressure in the postoperative period.
- Glaucoma after cataract surgery.
- A pronounced increase in intraocular pressure with the risk of damage to the eye (including as part of a combination antiglaucoma therapy).

Contraindications

- Acute iritis.
- Bronchial asthma (including a history).
- Acute or chronic obstructive pulmonary disease.
- Sinus bradycardia.
- AV blockade II and III degree.
- heart failure.
- Cardiogenic shock.
- Hypersensitivity to the drug.

Pregnancy and Breastfeeding

To date, not enough adequate and well-controlled studies have been conducted in pregnant women. Use of Fotil during pregnancy and lactation is possible only when the intended benefit to the mother outweighs the potential risk to the fetus. In experimental studies there was no negative effect of timolol on fertility. Currently, there is no evidence that during the treatment of glaucoma in humans, pilocarpine has a teratogenic effect.

Dosage and administration

Assign 1 drop of the drug Fotil in the affected eye 2 times / day.In some patients, a steady decrease in intraocular pressure is achieved only after several 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 reduction in intraocular pressure does not occur, then Fotil forte should be administered 1 drop 2 times / day.

Adverse reactions

Local reactions due to pilocarpine: quick burning sensation and pain, spasm of ciliary muscle, conjunctival hyperemia, induced myopia (these reactions are more common in young people at the beginning of treatment). Due to miosis, visual acuity may decrease with insufficient light. Rarely - iris stiffness, iris cyst, retinal detachment; with prolonged use in some cases - reversible clouding of the lens.
Local reactions due to timolol maleate: corneal anesthesia, punctate 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.

Special notes

The drug is prescribed to patients who can not compensate for increased intraocular pressure using monotherapy in almost all forms of glaucoma.
Caution must be exercised in the appointment of the drug to patients receiving beta-blockers inside.
With prolonged use of the drug in patients with glaucoma may develop resistance to the active components of the drug. However, the degree of development of tolerance is less pronounced for combined eye drops than for monocomponent antiglaucoma preparations.
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 drug contains a preservative, patients wearing soft contact lenses should remove them before using drops. It is recommended to wait 15 minutes before reinserting contact lenses.
During the period of use of the drug may dark adaptation. The patient should be warned about the danger of movement in the dark.
The results of experimental studies: in studies conducted on laboratory animals, no mutagenic action of timolol was detected. Currently, there is no evidence that during the treatment of glaucoma in humans, pilocarpine has a mutagenic effect. However, in experimental studies revealed signs of mutagenicity of pilocarpine.
Influence on ability to drive motor transport and control mechanisms: Drivers should be careful when driving in low light conditions, since The drug may interfere with dark adaptation.

Drug Interactions

When applying Fotil (which includes timolol), simultaneously with beta-blockers for oral administration, the pharmacological effect of beta-blockers is enhanced. With simultaneous use of the drug Fotil with Calcium channel blockers such as Verapamil, AV conduction disturbances, development of left ventricular insufficiency, arterial hypotension are possible. With simultaneous use of Fotil with drugs that promote the release of catecholamines (for example, with reserpine), in isolated cases hypotension (including orthostatic), bradycardia, dizziness were observed.

Overdosage

Symptoms: bradycardia, arterial hypotension, bronchospasm, acute heart failure.
Treatment: conduct symptomatic therapy. Atropine can be used as an antidote to pilocarpine. The purpose of isoprenaline for severe bradycardia, bronchospasm is shown; dobutamine - for hypotension; cardiac glycosides, diuretic drugs - in the event of acute heart failure.

Storage conditions

The drug should be stored at a temperature of 2 ° to 8 ° C.