Xalatamax - instructions for use, dose, side effects, contraindications

Benzalkonium chloride 0.20 mg; sodium dihydrogen phosphate monohydrate - 4.60 mg; sodium hydrophosphate - 4.74 mg; sodium chloride - 4,10 mg; purified water - 996.31 mg.

Description:Colorless transparent liquid.

Pharmacotherapeutic group:Antiglaucoma means - prostaglandin F2α analogue synthetic

ATX: & nbsp

S.01.E.E Prostaglandin analogues

S.01.E.E.01 Latanoprost

Pharmacodynamics:

Latanoprost is an analog of prostaglandin F₂_α and a selective agonist 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 the administration of the drug, the maximum the effect is observed after 8-12 hours, the duration of the action is not less than 24 hours.

Pharmacokinetics:

It penetrates well through the cornea, with the hydrolysis of latanoprost to the biologically active form - latanoprost acid. The maximum concentration 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. The half-life 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.

Contraindications:

Individual hypersensitivity to latanoprost, benzalkonium chloride or other components of the drug, age to 18 years.

Carefully:

Use with caution 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, cases of development of macular edema, including cystoid) are described, inflammatory, congenital glaucoma due to lack of experience.

Pregnancy and lactation:

Sufficient experience in the use of the drug during pregnancy and during lactation there. The use of latanoprost during pregnancy is possible only under the supervision of a doctor and only if the expected benefit for the mother exceeds the risk of developing possible side effects in the fetus.

Latanoprost and its metabolites can penetrate into the mother's milk. If it is necessary to administer Latanax during lactation, breastfeeding should be discontinued.

Dosing and Administration:

The drug is buried in the conjunctival eye bag 1 drop once a day, in the evening; when a dose is missed, the next one 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 effects:

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 the 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, , thickening, increase in the number and intensification of the pigmentation of eyelashes and fleece hair, iritis / uveitis, keratitis, macular edema (including cystoid), a change in the direction of growth of the eyelashes, sometimes causing eye irritation, blurred vision.

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

From the nervous system: dizziness, headache.

From the respiratory system: bronchial asthma (including acute attacks or exacerbation of the disease in patients with bronchial asthma in the anamnesis), dyspnea.

From the musculoskeletal system: pain in the muscles, joint pain.

Other: nonspecific pain in the chest.

Overdose:

Symptoms: irritation of the mucous membrane of the eye, hyperemia of the conjunctiva or episcler.

Treatment: conduct symptomatic therapy.

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. Research in vitro revealed that when mixed with latanoprost eye drops containing thiomersal, precipitation occurs. 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.

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 observed 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 melanin content 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 may get 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 ofnevi or lentigo on the iris did not show their changes under the influence of therapy.

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. 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. The preparation 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.

Effect on the ability to drive transp. cf. and fur:

Patients who, after applying eye drops, have a transient fogging of vision, it is not recommended to drive or work with moving mechanisms before it is restored.

Form release / dosage:

Eye drops 0.005%.

Packaging:

For 2.5 ml in plastic bottles with pipette dispenser and screw cap. The bottle is packed in a pack of cardboard along with instructions for use.

Storage conditions:

Store in a dry place, protected from light, out of reach of children, at a temperature of 2 to 8 ° C. The opened vial should be stored at a temperature not exceeding 25 ° C.

Shelf life:

2 years. Do not use after the expiry date printed on the package. After opening the vial, the drug should be used within 4 weeks.

Terms of leave from pharmacies:On prescription

Registration number:LP-000193

Date of registration:04.02.2011

The owner of the registration certificate:ABBOTT LABORATORIES, LTD. ABBOTT LABORATORIES, LTD. Russia

Manufacturer: & nbsp

JADRAN Galenski Laboratorij, d.d. Croatia

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp17.11.2015

Illustrated instructions

Instructions

Xalatamax® (Xalatamax®)