Xalatamax, eye drops 0.005%, 2.5ml

Composition

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1 ml contains:

Active ingredients:

latanoprost 0.05 mg;

Auxiliary substances:

benzalkonium chloride-200 mcg,

sodium dihydrogen phosphate monohydrate-4.6 mg,

sodium hydrophosphate-4.74 mg,

sodium chloride-4.1 mg,

purified water-996.31 mg

Pharmacological action

Anti-glaucoma drug for topical application. Latanoprost is an analog_{of prostaglandin f2a} and a selective agonist of FP receptors. By increasing the outflow of aqueous humor, it reduces intraocular pressure and has an anti-glaucoma effect. The main mechanism of action is an increase in uveoscleral outflow. It has no significant effect on the production of aqueous humor and does not affect the hemato-ophthalmic barrier.

A decrease in intraocular pressure begins 3-4 hours after use of the drug, the maximum effect is noted in 8-12 hours, the duration of action is at least 24 hours

. Pharmacokinetics

Suction

It penetrates well through the cornea, and latanoprost is hydrolyzed to a biologically active form-latanoprost acid. _{Cmax of}latanoprost in aqueous humor is reached approximately 2 hours after topical application of the drug.

In the tissues of the eye, latanoprost acid is practically not metabolized; metabolism occurs mainly in the liver.

Metabolism and elimination

T_1/2 is 17 min. The main metabolites-1,2-dinor-and 1,2,3,4-tetranor-metabolites do not have or have weak biological activity, are excreted by the kidneys.

Indications

Reduction of elevated intraocular pressure (IOP) in adults and children (over the age of 1 year) with open-angle glaucoma or increased ophthalmotonus.

Use during pregnancy and lactation

Use during pregnancy is contraindicated. If it is necessary to use the drug, breastfeeding should be discontinued. No effect of latanoprost on male and female fertility was found in animal studies.

Contraindications

• Hypersensitivity to latanoprost or other components of the drug.
• Age up to 1 year (efficacy and safety have not been established).

Side effects

From the side of the visual organ:  Eye irritation (burning sensation, sand sensation in the eyes, itching, tingling and foreign body sensation), blepharitis, conjunctival hyperemia, eye pain, increased iris pigmentation, transient point erosion of the epithelium, eyelid edema, corneal edema and erosion, conjunctivitis, elongation, thickening, increased number and pigmentation of eyelashes and downy hair, iritis/uveitis, keratitis, macular edema (including cystoid edema). ), changes in the direction of eyelash growth, sometimes causing eye irritation, blurred vision.

Dermatological reactions:  Rash, darkening of the skin of the eyelids and local skin reactions from the eyelids.

Nervous system disorders:  Dizziness headache.

Respiratory system disorders:  Bronchial asthma (including acute attacks or exacerbation of the disease in patients with a history of bronchial asthma), shortness of breath.

Musculoskeletal disorders:  Muscle pain, joint pain.

Other 6 Non-specific chest pain.

Interaction

Latanoprost has an additive effect on lowering intraocular pressure when used in combination with beta-blockers, adrenomimetics, carbonic anhydrase inhibitors and a partial additive effect when used in combination with m-cholinomimetics.

In vitro studies have shown that when mixed with latanoprost eye drops containing thiomersal, precipitation occurs. Therefore, eye drops containing these substances should be applied at intervals of at least 5 minutes.

Simultaneous use of 2 prostaglandin analogues can cause a paradoxical increase in intraocular pressure.

How to take, course of use and dosage

The drug is instilled into the conjunctival sac of the eyes 1 drop 1 time/day, in the evening.

If a dose is missed, the next dose is administered as usual (i. e., the dose is not doubled).

With more frequent use of the drug, its effectiveness decreases.

The duration of the course of treatment and the possibility of its repetition are determined by the doctor.

Overdose

In case of overdose, symptomatic treatment is performed. In addition to irritation of the eye mucosa, conjunctival or episcleral hyperemia, other undesirable changes on the part of the visual organ with an overdose of latanoprost are not known.

Description

Eye drops 0.005% transparent, colorless.

Special instructions

Latanoprost can cause a gradual change in eye color due to an increase in the amount of brown pigment in the iris. This effect is detected mainly in patients with mixed color of the iris, for example, blue-brown, gray-brown, green-brown or yellow-brown, which is explained by an increase in the content of melanin in the stromal melanocytes of the iris.

Usually, brown pigmentation spreads concentrically around the pupil to the periphery of the iris, and the entire iris or parts of it may turn a more intense brown color. In patients with evenly colored blue, gray, green or brown eyes, changes in eye color after two years of using the drug were very rare. The color change is not accompanied by any clinical symptoms or pathological changes. After discontinuation of the drug, there was no further increase in the amount of brown pigment, but the color change that has already developed may be irreversible. In the presence of nevi or lentigo on the iris, their changes were not noted under the influence of therapy.

Before starting treatment, patients should be informed about the possibility of changing eye color. In case of intense changes in eye pigmentation, treatment may be discontinued. Treating only one eye can lead to permanent heterochromia.

Latanoprost can cause gradual changes in the eyelashes and downy hair, such as lengthening, thickening, increasing pigmentation, increasing density, and changing the direction of lash growth. Changes to the eyelashes are reversible and disappear after treatment is stopped.

The drug contains benzalkonium chloride, which can be absorbed in contact lenses. When using contact lenses, remove them before instillation and put them back on 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.

Influence on the ability to drive motor vehicles and manage mechanisms

Patients who experience temporary blurred vision after applying eye drops are advised not to drive a car or work with moving machinery until it is restored.

Form of production

Xalatamax. Eye drops 0.005%

Storage conditions

Store in a dark place at a temperature of 2 to 8 °C. The opened bottle should be stored at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

1 year

Active ingredient

Latanoprost

Conditions of release from pharmacies

By prescription

Dosage form

eye drops