Expiration date: 01/2025
The composition and form of issue:
Eye drops, 1 ml contains:
pilocarpine hydrochloride 20 mg
timolol maleate (in terms of timolol), 5 mg
excipients: benzalkonium chloride 0.1 mg citric acid (monohydrate) sodium citrate hypromellose water for injections
in plastic vials-droppers of 5 ml in box of 1 vial.
Eye drops, 1 ml contains:
pilocarpine hydrochloride 40 mg
timolol maleate (in terms of timolol), 5 mg
excipients: benzalkonium chloride 0.1 mg citric acid (monohydrate) sodium citrate hypromellose water for injections
in plastic vials-droppers of 5 ml in box of 1 vial.
Description pharmaceutical form:
Transparent, slightly bitter, colorless watery liquid with no odor.
Pharmacological action:
Timolol blocks beta-adrenergic receptors and reduces the production of intraocular fluid.
Pilocarpine stimulates m-cholinergic receptors, improves the outflow of intraocular fluid.
Pharmacokinetics:
Pilocarpine penetrates well into the cornea, reaching a Cmax in watery moisture after 30 min. Contacts many eye tissues, T1/2 of the eye ranges from 1.5 to 2.5 hours there is metabolized into watery moisture, standing out with her. Accompanying the appointment of timolol, which reduces the formation of intraocular fluid reduces the rate of elimination of pilocarpine. Rapidly hydrolyses in blood serum and in the liver to an inactive form. T1/2 from plasma is less than 30 min.
Timolol is rapidly absorbed through the cornea. Decreases intraocular pressure 2 hours after topical application. The maximum effect is reached after 4 h and the effect lasts for 10-20 h.
Description pharmacological action:
Pilocarpine by stimulating the muscarinic receptors, reduces the intraocular pressure by contraction of ciliary muscles and the muscles of the iris that leads to the expansion of the anterior chamber angle of the eye and changes the physical structure of trabecular tissue, facilitating the outflow of aqueous humor (the effect lasts from 4 to 14 h).
Timolol prevents the binding of neurotransmitters with sympathomimetic beta2-adrenergic receptors in ciliary body reduces the production of aqueous humor, thus reducing intraocular pressure.
Indications:
Open-angle and angle-closure glaucoma, glaucoma with aphakia, secondary glaucoma, severe rise in intraocular pressure (in combination with other agents), increase in intraocular pressure after surgery eye.
Contraindications:
Hypersensitivity to any component of the drug, acute iritis, sinusova aetiology, AV blockade II and III level, heart failure decompensation, cardiogenic shock, bronchial asthma, chronic obstructive pulmonary disease in a heavy form.
With careful use in cerebrovascular disorders, heart failure, asthma, diabetes and hypoglycemia, thyrotoxicosis before surgery involving General anesthesia.
Application of pregnancy and breast-feeding:
The drug should not be used during pregnancy and lactation unless the expected therapeutic effect outweighs the potential risk to the fetus.
Side effects:
Local: quickly passing burning sensation and eye pain, increased lacrimation, conjunctival redness, temporal and supraorbital headache, myopia associated with timolol: decreased sensitivity of the cornea, point keratitis, syndrome of the dry eye, dermatitis of the eyelids possible: ciliary muscle spasm, induced myopia, reduced visual acuity in poor light (due to miosis).
Systemic: nausea, diarrhea, sweating, increased salivation, decreased blood pressure, asthmatic attack, heart failure, arrhythmia.
Drug interactions:
Drugs that violate the Deposit of catecholamines (reserpine) contribute to the development of arterial hypotension (including orthostatic), bradycardia and dizziness.
Concomitant use of beta-blockers for systemic effects leads to an enhancement of their pharmacological effect.
Method of application and dose:
The conjunctival. 1 drop in the affected eye 2 times per day.
If the usual dosage intraocular pressure remains elevated, it can be increased: 1 drop drops fotil Forte 2 times a day.
Overdose:
Symptoms: bradycardia, decreased blood pressure, bronchospasm and acute cardiac insufficiency.
Treatment: symptomatic atropine as antidote for pilocarpine, isoprenaline — in/in, to correct severe bradycardia or bronchospasm, dobutamine — for the treatment of arterial hypotension.
Precautions:
Timolol penetrates through the BBB and affects the Central nervous system, especially in overdose. In elderly patients with heart failure in history can be observed: the asthenic syndrome, vomiting, dizziness, anxiety, hallucinations, headache, and depression rarely nasal congestion, diplopia, ptosis.
A few cases of retinal detachment, rigidity of the iris, or cyst formation in the iris of the eye was noted in connection with the use of miotic drugs. Reversible clouding of the lens was observed with prolonged use of pilocarpine.
Symptoms of contact Allergy and allergic dermatitis of the eyelid skin were noted during therapy with preparations containing pilocarpine. In patients with hypersensitivity to the timolol maleate can cause rashes, hives or allergic blepharoconjunctivitis.
The risk of development of tolerance have combined drops less than under the use of preparations containing only one active substance.
Care must be taken when driving in the dark or in low light.
Before burying you should remove contact lenses and re-install them after 15 min after drug administration.
Safety and effectiveness in children have not been established.
Special instructions:
Should not be used concurrently with other drugs containing b-blockers.
The use of other eye drops should be discontinued before starting treatment with the drug. Previous antiglaucoma tool is required to cancel, and therapy of eye drops drops fotil to start the next day. Evaluation of the effectiveness of the treatment should be within 4 weeks after the start of treatment (some patients several weeks may develop tolerance).
Treatment is carried out with regular monitoring of intraocular pressure.
Storage conditions:
Open vials at room t (25 °C), protected from light.
Expiration date:
After opening bottle - 1 month.
