Composition, form of production and packaging
Eye drops transparent, colorless.
1 ml
latanoprost 50 Ојg
Excipients: sodium chloride - 4.1 mg, benzalkonium chloride - 0.2 mg, sodium hydrophosphate - 4.74 mg, sodium dihydrogen phosphate monohydrate - 4.6 mg, water d / and - 0.9974 mg.
2.5 ml - a vial of a dropper (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Antiglaucoma preparation, analogue of prostaglandin F 2? , is a selective agonist of the prostanoid FP receptor. The drug reduces intraocular pressure (IOP) by increasing the outflow of aqueous humor, mainly by the uveoscleral route, and also through the trabecular network.
It has been established that latanoprost does not significantly affect the production of aqueous humor and the hemato-ophthalmic barrier. In the short-term treatment of patients with pseudoafacies, latanoprost does not cause fluorescin to enter the posterior segment of the eye.
When used in therapeutic doses, latanoprost does not have a significant pharmacological effect on the cardiovascular and respiratory systems.
Decrease in IOP begins approximately 3-4 hours after the administration of the drug, the maximum effect is observed after 8-12 hours, the effect is maintained for at least 24 hours.
PHARMACOKINETICS
Suction
Latanoprost, being a prodrug, is absorbed through the cornea, where its hydrolysis occurs to a biologically active acid. With MAX in aqueous humor is achieved approximately 2 hours after topical application.
Distribution
V d is about 0.16 l / kg. Latanoprost acid is determined in aqueous humor during the first 4 hours, and in plasma only within the first hour after topical application.
INDICATIONS
- open-angle glaucoma;
increased intraocular pressure.
DOSING MODE
Locally. Bury 1 drop in the conjunctival sac of the affected eye 1 time / day, in the evening.
To reduce the possible systemic absorption, it is recommended to press the middle of the inner corner of the eye for one minute (occlusion of lacrimal points) after instillation of each drop of the drug.
Do not exceed the daily dose of latanoprost. more frequent use of the drug reduces the effect of reducing IOP.
In case of missing the dose, the following use of the drug Latatomol is carried out in the usual mode, that is, the dose is not doubled.
SIDE EFFECT
Determination of the frequency of side effects: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100) rarely (> 1/10 000, <1 / 1000), very rarely (<1/10 000, including individual messages).
From the side of the organ of vision: very often - increased pigmentation of the iris, irritation of the eyes (burning sensation, sensation of sand in the eyes, itching, tingling and foreign body sensation), lengthening, thickening, increase in the number and intensification of eyelash pigmentation; often congestion hyperemia, transient point erosions of the epithelium (often asymptomatic), blepharitis, pain in the eyes; infrequently - the swelling of the eyelids, keratitis, blurred vision; rarely iritis / uveitis, macular edema (including cystoid), edema and erosion of the cornea, periorbital edema, darkening of the skin of the eyelids, local skin reactions from the eyelids, changes in the direction of growth of the eyelashes (sometimes causing eye irritation), elongation, thickening , increase in the number and intensification of pigmentation of the hair of the eyelids, distichiasis.
From the cardiovascular system: often - palpitations; very rarely - the progression of angina pectoris.
On the part of the respiratory and mediastinal organs: rarely - bronchial asthma (including acute attacks or exacerbation of the disease in patients with bronchial asthma in the anamnesis), shortness of breath.
From the skin: rarely - skin rash.
From the nervous system: rarely - dizziness, headache.
From the musculoskeletal system: rarely - pain in muscles, joint pain.
Common violations: very rarely - nonspecific pain in the chest.
CONTRAINDICATIONS
- children and adolescence under 18;
- Hypersensitivity to the components of the drug.
With care: aphakia, psevdophakia with a rupture of the posterior capsule of the lens; patients with known risk factors for macular edema (in the treatment with latanoprost, cases of development of macular edema, including cystoid edema); inflammatory, neovascular or congenital glaucoma (due to a lack of sufficient experience in the use of the drug).
PREGNANCY AND LACTATION
The use of the drug Latatomol during pregnancy is possible only under the supervision of a doctor and only if the expected benefit for the mother exceeds the potential risk to the fetus.
Latanoprost and its metabolites can be excreted in breast milk. If it is necessary to administer the drug Latatomol during lactation, breastfeeding should be discontinued.
SPECIAL INSTRUCTIONS
Latanoprost is able to cause a gradual change in the color of the iris of the eyes by increasing the amount of brown pigment in the iris. This effect is mainly seen in patients with a mixed color of the iris, for example, blue-brown, gray-brown, green-brown or yellow-brown, which is explained by an increase in melanin in the stromal melanocytes of the iris. Usually, brown pigmentation spreads concentrically around the pupil to the periphery of the iris of the eyes, while the entire iris or parts of it can acquire a more intense brown color. In the case of an intense change in eye pigmentation, therapy is discontinued.
In patients with a uniformly colored iris of the eyes of blue, gray, green or brown, changes in the color of the iris after 2 years of use of the drug are very rare. The developed color change can be irreversible. Before starting treatment, patients should be informed about the possibility of changing the color of the iris of the eyes.
Latanoprost can cause gradual changes in eyelashes and fleece hair, such as lengthening, thickening, increasing pigmentation, increasing the density and changing the direction of growth of the eyelashes. The eyelash changes are reversible and pass after the cessation of treatment.
Patients who apply drops to only one eye may develop heterochromia.
Latamonom contains benzalkonium chloride, which can be absorbed by contact lenses. Before instilling eye drops, contact lenses should be removed; You can insert the lenses only 15 minutes after instillation.
Impact on the ability to drive vehicles and manage mechanisms
With the use of the drug Latatomol, short-term blurring of vision (sensation of "shroud before the eyes") can develop, therefore, before the disappearance of this effect, it is necessary to refrain from driving and other potentially dangerous mechanisms.
OVERDOSE
Symptoms: irritation of the mucous membrane of the eye, hyperemia of the conjunctiva or episcler.
Treatment: symptomatic therapy.
DRUG INTERACTION
Simultaneous instillation of two analogues of prostaglandins can cause a paradoxical increase in IOP.
Pharmaceutically incompatible with eye drops containing thiomersal (a precipitation reaction develops).
When prescribing a combination therapy, eye drops of various drugs should be injected with an interval of at least 5 minutes.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light, at a temperature of 2 В° to 8 В° C. Shelf life - 3 years.
The opened vial should be stored at a temperature not higher than 25 В° C and used within 4 weeks.
