Fotil eye drops 40 mg / ml + 5 mg / ml 5 ml (Pilocarpine, Timolol)

Latin name

Fotil forte

Release form

Fotil forte. Eye drops in the form of a clear, colorless solution.

Packaging

5 ml - polyethylene dropper bottle (1) - packs of cardboard.

Pharmacological action

Combined antiglaucoma.

Pilocarpine - m-cholinomimetic. When instilled into the eye, pilocarpine causes miosis, accommodation spasm and reduces intraocular pressure. The decrease in intraocular pressure is due to the contraction of the 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-blocker, prevents the binding of sympathomimetic neurotransmitters to 1- and 2-adrenergic receptors in the ciliary body. Reduces intraocular pressure reducing the production of aqueous humor. The antihypertensive 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 aqueous humor reaches its maximum after 30 minutes. Pilocarpine binds to many tissues of the eye. T1 / 2 from the medium 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 aqueous humor, slows down the rate of pilocarpine excretion.

Pilocarpine is rapidly hydrolyzed to inactive forms in plasma and liver. T1 / 2 is less than 0.5 hours.

Timolol quickly penetrates through the cornea into the aqueous humor of the anterior chamber of the eye. About 80% of topically applied timolol enters the systemic circulation. Cmax in blood plasma is determined approximately 1 hour after the installation of eye drops.

Metabolized mainly in the liver. T1 / 2 is 2-5 hours. It is excreted mainly through the kidneys.

Contraindications

anterior uveitis

sinus bradycardia

AV block II and III degree

decompensated heart failure

cardiogenic shock

bronchial asthma

COPD unresponsive 18 years old with no previous years children and adolescents)

condition immediately after ophthalmic surgery and other eye diseases in which pupil constriction is undesirable

hypersensitivity to the components of the preparations ata.

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

Use during pregnancy and lactation

Use of the drug Photil forte during pregnancy and breastfeeding is possible only when the intended benefit to the mother outweighs the potential risk to the fetus.

Composition

1 ml eye drops contains:

Active ingredients: timolol maleate 6.84 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 / i - up to 1 ml.

Dosage and administration

Assign 1 drop in the affected eye 2 times / day. In some patients, a stable decrease in intraocular pressure caused by the use of Fotil is achieved only after a few 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 decrease in intraocular pressure does not occur during treatment with Fotil eye drops, then treatment with Fotil forte eye drops should be continued 1 drop 2 times / day.

Side effects

Local reactions: blurred vision, eye irritation, rapidly passing burning sensation and pain in the eye, increased lacrimation, dry eye syndrome, eyelid dermatitis, conjunctival redness, ciliary muscle spasm and induced myopia, decreased visual acuity in low light ( due to myosis), decreased sensitivity of the cornea, point keratitis, allergic blepharoconjunctivitis is very rare - diplopia, ptosis.

Several cases of retinal detachment, iris rigidity, or cyst formation in the iris have been noted in connection with the use of miotic agents. With prolonged use of pilocarpine, reversible lens opacification 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 crosses the BBB and has an effect on the central nervous system.

In all heart failure patients, timolol can cause asthenic syndrome, nausea, dizziness, anxiety, hallucinations, headache, and depression.

Nasal congestion was very rare.

Drug Interaction

With the simultaneous use of Fotil fort with drugs that promote catecholamines (eg, with reserpine), arterial hypotension (including orthostatic), bradycardia, and dizziness were observed in isolated cases.

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

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

Overdose

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

Treatment: carry out symptomatic therapy. Atropine can be used as an antidote to pilocarpine. The use of isoprenaline in / in the case of severe bradycardia, bronchospasm of dobutamine - in arterial hypotension is shown.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 2 ° to 8 ° C. After opening the package, the drug can be stored at a temperature not exceeding 25 ° C.

The Expiration of

is 3 years. After opening the package - 1 month.

Deystvuyuschee substances

Pylokarpyn , Timolol

Pharmacy terms

Prescription

dosage form

dosage form

eye drops

Santen, France



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