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Active ingredients
Pilocarpine + Timolol
Release form
Drops
Composition
1 ml contains timolol maleate 6.84 mg, which corresponds to the content of timolol 5 mg, pilocarpine hydrochloride 20 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;
Pharmacological effect
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 - beta-blocker, prevents the stimulating effect of catecholamines on β-adrenergic receptors. Reduces intraocular pressure by reducing the formation of intraocular fluid. ; Pilocarpine and timolol, when combined in one preparation, mutually reinforce each other's effects. ;
Pharmacokinetics
Timolol; Quickly penetrates the cornea. ; Reducing the formation of intraocular fluid, reduces the rate of excretion of pilocarpine from the eye. ; Pilocarpine; Well penetrates the cornea. Cmax in intraocular fluid is reached after 30 minutes. Pilocarpine binds in most tissues of the eye, which prolongs its half-life from the eye, which ranges from 1.5 to 2.5 h. Pilocarpine, unchanged, is excreted from the tissues of the eye along with intraocular fluid. ; In blood plasma and liver quickly hydrolyzed to an inactive form. T1 / 2 from blood plasma - less than 0.5 hours;
Indications
Glaucoma or increased intraocular pressure, when a combination of timolol and pilocarpine is needed: - open-angle glaucoma; - angle-closure glaucoma; - secondary glaucoma; - increase in intraocular pressure after ophthalmologic operations;
Contraindications
Hypersensitivity to any of the components of the drug, acute iritis, sinus bradycardia, AV block II and III degrees, heart failure in the stage of decompensation, cardiogenic shock, bronchial asthma, chronic obstructive pulmonary disease in a severe form .; To use with caution in cerebrovascular disorders, heart failure, bronchial asthma, diabetes mellitus and hypoglycemia, thyrotoxicosis, before operations with general anesthesia;
Use during 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 outweighs the potential risk to the fetus;
Dosage and administration
Conjunctival. 1 drop in the affected eye 2 times a day .; If at normal dosage the intraocular pressure remains elevated, it can be increased: 1 drop Fotil forte 2 times a day;
Side effects
Local: quickly passing burning sensation and pain in the eye, increased tearing, conjunctival redness, temporal and supra-orbital headaches, myopia; associated with timolol: reduced corneal sensitivity, punctate keratitis, dry eye syndrome, eyelid dermatitis; possible: spasm of the ciliary muscle, induced myopia, reduced visual acuity in low light (due to miosis) .; Systemic: nausea, diarrhea, increased sweating, increased salivation, lowering blood pressure, asthma attack, heart failure, arrhythmia .;
Overdose
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 in / in with severe bradycardia, bronchospasm; dobutamine - with arterial hypotension;
Interaction with other drugs
With simultaneous use of Fotil forte with drugs that promote the release of catecholamines (for example, with reserpine), in isolated cases arterial hypotension (including orthostatic), bradycardia, dizziness was observed .; The 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 developing disorders of cardiac conduction and arterial hypotension .; CYP2D6 isoenzyme inhibitors, such as quinidine and cimetidine, can increase the concentration of timolol in the plasma;
special instructions
Fotil forte eye drops should not be used simultaneously with other eye drops containing beta-blockers .; The use of other eye drops should be discontinued before the treatment with Fotil Forte is started.The previous antiglaucoma should be discontinued, and the Fotil Forte therapy should be started the next day .; Evaluation of the effectiveness of the drug should be carried out 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 .; Fotil forte eye drops contain benzalkonium chloride as a preservative and are not recommended for use when wearing contact lenses. Before using the drug, remove the contact lenses and re-install them no earlier than 15 minutes after instillation of the drug .; Timolol, which is part of the drug, may mask the symptoms of hypoglycemia in patients with diabetes mellitus or the symptoms of hyperfunction of the thyroid gland .; In case of an upcoming surgery under general anesthesia, it is necessary to cancel Fotil forte 48 hours before the operation, since The drug enhances the action of muscle relaxants and general anesthetics .; Influence on the ability to drive motor vehicles and control mechanisms; The miotic effect can cause transient visual impairment (feeling of myopia), therefore, during the period of treatment, care must be taken when driving vehicles or operating any complex equipment that requires increased concentration and psychomotor speed;