Глаумакс

General characteristics. Structure:

Active component: латанопрост – 50 mkg.

Excipients: a benzalkoniya chloride – 0,2 mg, sodium chloride – 5,69 mg, sodium dihydrophosphate a dihydrate – 3,98 mg, dinatrium hydrophosphate anhydrous – 3,48 mg, water for injections – to 1,0 ml

Pharmacological properties:

Pharmacodynamics. Латанопрост – active agent of the drug Glaumaks®, is an analog of F2α prostaglandin and the selection agonist of F (FP) prostaglandin of receptors. Drug has protivoglaukomny effect. The main mechanism of effect of drug is connected with increase in uveoskleralny outflow. Reduces intraocular pressure by increase in outflow of watery moisture through an eyeglobe choroid. Drug has no significant effect on products of watery moisture and on a blood-ocular barrier, can slightly change the pupil sizes. After administration of drug decrease in intraocular pressure begins in 3-4 hours, the maximum effect is reached in 8-12 hours, action continues within not less than 24 hours.

Pharmacokinetics. Absorption: латанопрост well gets through a cornea, at the same time there is a hydrolysis of a latanoprost to biologically active form – latanoprost-acids. The maximum concentration of a latanoprost in watery moisture is reached approximately in 2 hours after topical administration of drug.

Distribution: латанопрост does not influence products of watery moisture, and renders the effect of decrease in intraocular pressure by increase in intraocular outflow. The maximum concentration of a latanoprost in watery moisture is reached in 2 hours after use. The volume of distribution of a latanoprost makes 0,16 ± 0,02 l/kg. Latanoprost-kislota, found soon after drug use, is the most essential metabolite of a latanoprost and is defined in watery moisture within the first 4 hours, and in plasma – only within the first hour after topical administration. In eye tissues latanoprost-acid does not undergo any further transformations, but after transition to a system blood stream is actively metabolized.

Metabolism: occurs mainly in a liver. The elimination half-life of a latanoprost makes 17 minutes. The main metabolites – 1,2 diholes and 1,2,3,4-tetranormetabolita do not possess or have weak biological activity. Final metabolites of a latanoprost are removed generally by kidneys: with urine about 88% of the entered dose of a latanoprost are removed.

Indications to use:

Decrease in intraocular pressure at patients:

- with an open angle glaucoma

- with the raised intraocular tension

Route of administration and doses:

Features of use:

Глаумакс® can cause gradual change of color of eyes due to increase in quantity of a brown pigment in an iris. This effect comes to light preferential at patients with the mixed coloring of an iris, for example, blue-brown, gray-brown, green-brown or yellowy-brown that is explained by increase in content of melanin in stromal melanocytes of an iris. Usually brown pigmentation extends concentrically around a pupil to the periphery of an iris of eyes, at the same time all iris or its parts can gain more rich brown color. At patients with evenly painted eyes of blue, gray, green or brown color of discoloration of eyes after 2 years of use of drug are observed very seldom. Discoloration is not followed by any clinical symptoms or pathological changes. After drug withdrawal further increase in quantity of a brown pigment was not observed, however already developed discoloration can be irreversible. Prior to treatment of patients it is necessary to inform on a possibility of discoloration of eyes. In case of intensive change of pigmentation of eyes therapy is stopped. Treatment only of one eye can lead to a constant heterochromia. In the presence лентиго on an iris their change under the influence of therapy is noted.

Darkening, thickening and lengthening of eyelashes, increase in their density and change of the direction of growth is possible.

Drug the benzalkoniya contains chloride which can be absorbed by contact lenses. Before an instillation of eye drops contact lenses should be removed; again it is possible to establish lenses only in 15-20 minutes after drug instillation. It is necessary to consider that against the background of therapy the short-term feeling of "veil" before eyes therefore it is not recommended to manage vehicles can develop or to work with moving mechanisms within several minutes after a drug instillation. The bottle needs to be closed after each use. It is not necessary to touch with a pipette tip an eye.

Side effects:

From organs of sight: allergic reactions from a century are possible. Less than at 1% of patients the following manifestations are possible: skin rash, allergic skin reactions on centuries, hypostasis and a hyperemia a century. Less than occur at 1% of patients: hypostasis and erosion of a cornea; irites, uveites; macular hypostasis, including cystous. More than at 10% of patients arise: irritation of eyes, eye pain, burning, an itch, feeling of a foreign body after instillation, sight misting. Occur at 1-10% of patients: konjyuktivalny hyperemia, tranzitorny dot epithelial erosion, blepharites, strengthening of pigmentation of an iris. Less than occur at 1% of patients: konjyuktivit, a diplopia, an embolism of arteries of a retina, amotio of a retina, a vitreous hemorrhage.

From a musculoskeletal system: muscle, joints pain to a back (frequency is unknown).

From respiratory system: deterioration in a course of bronchial asthma, a bad attack of bronchial asthma, short wind (frequency is unknown).

From cardiovascular system: at 1-2% of patients – pain in breast/stenocardia.

Interaction with other medicines:

Глаумакс® has the additive effect in a combination with beta adrenoblockers (Timololum), adrenomimetikam (Epinephrinum), inhibitors of a karboangidraza (acetazoleamide) and, to a lesser extent, about m cholinomimetics (Pilocarpinum).

Use of drug is incompatible with the eye drops containing tiomersat (there is precipitation).

Contraindications:

- individual hypersensitivity to a latanoprost, a benzalkoniya to chloride or other components of drug

- age up to 18 years

- feeding period breast

Overdose:

Symptoms: irritation of a mucous membrane of eyes, hyperemia of a conjunctiva or episclera. Treatment: carry out symptomatic therapy.

Storage conditions:

In the place protected from light at a temperature from 2 ºС to 8 ºС. To store the opened bottle at a temperature not over 25 ºС. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 2,5 ml of sterile solution of a latanoprost of 0,005% in a polymeric bottle with a capacity of 5 ml with a dropper and the putting-on cap; on 1 bottle dropper with the instruction on a medical use in a pack from a cardboard.