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

The combination drug contains two active ingredients. Pilocarpine in the form of eye drops causes constriction of the pupil and accommodation spasm, and also reduces intraocular pressure by contracting the ciliary muscle and iris muscle, which facilitates outflow of aqueous humor from the anterior chamber of the eye. The effect of pilocarpine occurs within 30 minutes and lasts 4-14 hours, the elimination half-life is 1.5 to 2.5 hours. The substance is not metabolized, it is excreted with aqueous humor.

Timolol is a beta-adrenoblocker that reduces intraocular pressure and reduces the production of aqueous humor by the visual organ. It acts mainly on the ciliary body. It slows down excretion of pilocarpine with aqueous humor. Its half-life is less than 30 minutes. Reduces intraocular pressure 2 hours after injection into the eye. Maximum effect should be expected after 4 hours, the effect lasts from 10 to 20 hours.

Pilocarpine and timolol mutually reinforce each other’s effects when combined in the same drug.

When used topically, Fotil decreases both elevated and normal intraocular pressure without regard to the presence of glaucoma. After a single single dose of Fotil the intraocular pressure begins to decrease after 30 minutes, the maximum effect is usually achieved after 2 hours and the action lasts for 20 hours.

Pharmacokinetics

Timolol

It penetrates rapidly through the cornea.

Decreasing intraocular fluid formation, decreases the rate of pilocarpine excretion from the eye.

Pilocarpine

Pilocarpine penetrates well through the cornea. C max in the intraocular fluid is reached after 30 min. Pilocarpine binds in most tissues of the eye prolonging its half-life from the eye which is 1.5 to 2.5 h. Pilocarpine is excreted unchanged from the eye tissues with the intraocular fluid.In blood plasma and liver it is rapidly hydrolyzed to the inactive form. T 1/2 from blood plasma is less than 0.5 h.

Indications

Elevated intraocular pressure, Glaucoma

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

Active ingredient

Pilocarpine, Timolol

Composition

Eye drops in the form of a clear colorless solution.

1 ml timololol 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,

water d/i.

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How to take, the dosage

Prescribe 1 drop in the affected eye 2 times a day.

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

Intraocular pressure must therefore be measured after approx. 4 weeks after the start of treatment to evaluate the results.

If the expected decrease in intraocular pressure does not occur, Fotil forte 1 drop 2 times daily should be prescribed.

Interaction

In concomitant use of Photil with drugs that promote catecholamine release (e.g., reserpine), arterial hypotension (including orthostatic), bradycardia, dizziness were observed.

The concomitant use of beta-adrenoblockers and slow calcium channel blockers with systemic action leads to intensification of their pharmacological effect and increases the risk of cardiac conduction disorders and arterial hypotension.

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

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Special Instructions

Fotil eye drops should not be used concomitantly with other eye drops containing beta-adrenoblockers.

The use of other eye drops should be discontinued before starting therapy with Fotil. The previous antiglaucoma medication should be discontinued, and therapy with Fotil eye drops should be started the next day.

The efficacy of the drug should be evaluated 4 weeks after initiation of treatment with regular monitoring of intraocular pressure.

Continued treatment should also be performed with regular intraocular pressure monitoring.

Fotil eye drops contain benzalkonium chloride as a preservative and are not recommended for use while wearing contact lenses. Contact lenses should be removed and reinserted no sooner than 15 minutes after instillation of the product.

The Timolol in the product may mask the symptoms of hypoglycemia in diabetic patients or the symptoms of thyroid hyperfunction.

In case of upcoming surgery under general anesthesia, Photil® must be discontinued 48 hours prior to surgery because the drug potentiates the effects of muscle relaxants and general anesthetics.

Impact on driving and operating machinery

Myotic effect may cause transient visual impairment (myopia sensation); therefore, during treatment, caution should be exercised when driving motor transport or operating any complex equipment requiring increased concentration and rapid psychomotor reactions.

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Contraindications

• Hypersensitivity to drug components.
• Acute iritis.
• Bronchial asthma (including anamnesis).
• Acute or chronic obstructive pulmonary disease.
• Sinus bradycardia.
• AV blockade of degree II and III.
• Heart failure.
• Cardiogenic shock.

With caution is prescribed in hypoglycemia, cerebral circulatory disorders, heart failure, diabetes, thyrotoxicosis, cerebrovascular disorders, and before surgery in which general anesthesia is planned.

Side effects

Local reactions due to pilocarpine

A quick-onset burning sensation and pain, ciliary muscle spasm, conjunctival hyperemia, induced myopia (these reactions are more often seen in younger individuals at the beginning of treatment). Due to myiosis, decreased visual acuity in low light may occur. Rarely, iris stiffness, iris cysts, retinal detachment; with long-term use in some cases – reversible clouding of the lens.

Local reactions caused by timolol maleate

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

Systemic effects due to pilocarpine (rare)

Nausea, vomiting, diarrhea, increased sweating and salivation, arterial hypotension, headache, asthenia; nasal mucosal hyperemia.

Systemic effects due to timolol maleate (very rare)

Disorders of airway patency up to bronchospasm, signs of chronic heart failure, arrhythmia, hallucinations, confusion.

Overdose

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

Treatment: symptomatic therapy is carried out.

Atropine may be used as an antidote to pilocarpine.

Prescribing isoprenaline in severe bradycardia, bronchospasm; dobutamine in hypotension; cardiac glycosides, diuretics in acute heart failure.

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Pregnancy use

The use of Fotil during pregnancy and breastfeeding is possible only when the expected benefits to the mother outweigh the potential risk to the fetus or baby.

Preventive use in children

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

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Similarities

Fotil Forte