Composition, form of production and packaging
Eye drops 0.005% transparent, colorless.
1 ml
latanoprost 50 Ојg
Excipients: benzalkonium chloride - 200 Ојg, sodium dihydrogen phosphate monohydrate - 4.6 mg, sodium hydrophosphate - 4.74 mg, sodium chloride - 4.1 mg, purified water - 996.31 mg.
2.5 ml - plastic bottles with a pipette-dispenser (1) - packs cardboard.
2.5 ml - plastic bottles with a pipette-dispenser (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Antiglaucoma preparation for topical application. Latanoprost is an analogue of prostaglandin F 2? and a selective agonist of FP receptors. Reduces intraocular pressure by increasing the outflow of aqueous humor and has anti-glaucoma effect. The main mechanism of action of latanoprost is associated with an increase in uveoscleral outflow. Does not have a significant effect on the production of aqueous humor and does not affect the hemato-ophthalmic barrier.
Decrease in intraocular pressure begins 3-4 hours after drug administration, the maximum effect is observed after 8-12 hours, the duration of action is not less than 24 hours.
PHARMACOKINETICS
Suction
It penetrates well through the cornea, with the hydrolysis of latanoprost to the biologically active form - latanoprost acid. C max of latanoprost in aqueous humor is achieved approximately 2 hours after topical application of the preparation.
In the eye tissues, latanoprost acid is not practically metabolized; metabolism occurs mainly in the liver.
Metabolism and excretion
T 1/2 is 17 minutes. The main metabolites - 1,2-dinor- and 1,2,3,4-tetranor metabolites do not possess or have weak biological activity, are excreted by the kidneys.
INDICATIONS
- open-angle glaucoma;
increased intraocular pressure.
DOSING MODE
The drug is instilled in the conjunctival eye bag 1 drop once a day, in the evening. When the dose is missed, the next dose is administered in the usual mode (i.e., the dose is not doubled). With more frequent administration of the drug, its effectiveness decreases. The duration of the course of treatment and the possibility of its recurrence are determined by the doctor.
SIDE EFFECT
From the side of the organ of vision: irritation of the eyes (burning sensation, sensation of sand in the eyes, itching, tingling and sensation of foreign body), blepharitis, conjunctival hyperemia, pain in the eyes, increased pigmentation of the iris, transient point erosions of the epithelium, edema of the eyelids, edema and erosion of the cornea , conjunctivitis, elongation, thickening, increase in the number and intensification of pigmentation of eyelashes and fleece hair, iritis / uveitis, keratitis, macular edema (including cystoid), changes in the direction of eyelash growth, sometimes causing eye irritation, blurring of vision.
Dermatological reactions: a rash, darkening of the eyelid skin and local skin reactions from the eyelids.
From the nervous system: dizziness, headache.
On the part of the respiratory system: bronchial asthma (including acute attacks or exacerbation of the disease in patients with bronchial asthma in the anamnesis), shortness of breath.
From the musculoskeletal system: pain in the muscles, pain in the joints.
Other: nonspecific chest pain.
CONTRAINDICATIONS
- age up to 18 years;
- hypersensitivity to latanoprost, benzalkonium chloride or other components of the drug.
With caution should be used in patients with aphakia, pseudoafacies, damage to the posterior capsule of the lens and other risk factors for the development of macular edema (in the treatment with latanoprost there are cases of development of macular edema, including cystoid), inflammatory congenital glaucoma due to lack of sufficient experience application of the drug.
PREGNANCY AND LACTATION
Sufficient experience in the use of the drug during pregnancy and during lactation there. The use of Xalatamax during pregnancy is only possible under the supervision of a doctor and only if the expected benefit to the mother exceeds the risk of developing possible side effects in the fetus.
Latanoprost and its metabolites can be excreted in breast milk. If it is necessary to administer Xalatamax during lactation, breastfeeding should be discontinued.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
SPECIAL INSTRUCTIONS
Latanoprost can cause a gradual change in eye color by increasing the amount of brown pigment in the iris. This effect is mainly seen in patients with mixed iris color, 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. Typically, 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. Patients with uniformly colored eyes of blue, gray, green or brown color change eye color after two years of use of the drug were very rare. The color change is not accompanied by any clinical symptoms or pathological changes. After the drug was discontinued, there was no further increase in the amount of brown pigment, but the already developed color change may be irreversible. In the presence of nevi or lentigo on the iris, their changes were not observed under the influence of therapy.
Before starting treatment, patients should be informed about the possibility of changing eye color. In the case of an intensive change in eye pigmentation, treatment may be discontinued. Treatment of only one eye can lead to permanent heterochromia.
Latanoprost can cause gradual changes in eyelashes and fleece hair, such as lengthening, thickening, increased pigmentation, increased density and a change in the direction of growth of eyelashes. The eyelash changes are reversible and pass after the cessation of treatment.
The drug contains benzalkonium chloride, which can be absorbed in contact lenses. If contact lenses are used, they should be removed before instillation and re-dressed no earlier than 15-20 minutes after instillation of the drug.
The bottle must be closed after each use.
Do not touch the tip of the pipette to the eye.
Impact on the ability to drive vehicles and manage mechanisms
Patients who, after application of eye drops, have a transient fogging of vision, it is not recommended to drive or work with moving mechanisms until it is restored.
OVERDOSE
Symptoms: irritation of the mucous membrane of the eye, hyperemia of the conjunctiva or episcler.
Treatment: symptomatic therapy.
DRUG INTERACTION
Latanoprost has an additive effect on reducing intraocular pressure when used in combination with beta-blockers, adrenomimetics, carbonic anhydrase inhibitors and partial additive action when used in combination with m-cholinomimetics.
In vitro studies have revealed that precipitation occurs when mixing with eye drops containing thiomersal with latanoprost. Therefore, eye drops containing these substances should be applied with an interval of at least 5 minutes.
Simultaneous use of 2 analogues of prostaglandins can cause a paradoxical increase in intraocular pressure.
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, dry, protected from light at a temperature of 2 to 8 В° C. Shelf life - 2 years.
The open vial should be stored at a temperature of no higher than 25 В° C. After opening the vial, the drug should be used within 4 weeks.
