Glaumax - instructions for use, doses, side effects, contraindications

Excipients: benzalkonium chloride - 0.2 mg, sodium chloride - 5.69 mg, sodium dihydrogen phosphate dihydrate - 3.98 mg, disodium hydrogen phosphate anhydrous - 3.48 mg, water for injection - up to 1.0 ml.

Description:

Transparent, colorless, odorless 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, the active substance of the Glaumax® preparation, is an analogue of prostaglandin F2_α and a selective agonist of prostaglandin F (FP) receptors. The drug has antiglaucomic effect.The main mechanism of action of the drug is associated with an increase in out-scleral outflow. Reduces intraocular pressure by increasing the outflow of watery moisture through the vascular membrane of the eyeball. The drug has no significant effect on the production of aqueous humor and on the hemato-ophthalmic barrier, it can slightly change the size of the pupil. After the administration of the drug, the decrease in intraocular pressure begins in 3-4 hours, the maximum effect is achieved after 8-12 hours, the effect lasts for at least 24 hours.

Pharmacokinetics:

Suction

Latanoprost well penetrates through the cornea, while the hydrolysis of latanoprost to a biologically active form - latanoprost-acid occurs. The maximum concentration of latanoprost in aqueous humor is achieved approximately 2 hours after topical application of the preparation.

Distribution

Latanoprost does not affect the production of watery moisture, but has its effect of reducing intraocular pressure by increasing intraocular outflow. The maximum concentration of latanoprost in aqueous humor is achieved after 2 hours after application. The volume of distribution of latanoprost is 0.16 ± 0.02 l / kg.Latanoprost-acid, detected shortly after application of the drug, is the most significant metabolite of latanoprost and is determined in aqueous humor within the first 4 hours, and in plasma only within the first hour after topical application. In the tissues of the eye, latanoprost-acid does not undergo any further transformation, but after the transition to the systemic blood flow is actively metabolized.

Metabolism

Metabolism of latanoprost occurs mainly in the liver. The half-life of latanoprost is 17 minutes. The main metabolites - 1,2-dinor- and 1,2,3,4-tetranor-metabolites do not possess or have weak biological activity. The final metabolites of latanoprost are excreted mainly by the kidneys: approximately 88% of the administered dose of latanoprost is excreted in the urine.

Indications:

Decreased intraocular pressure in patients:

- with open-angle glaucoma;

- with increased ophthalmotonus.

Contraindications:

- Individual hypersensitivity to latanoprost, benzalkonium chloride or other components of the drug;

- Age to 18 years;

- The period of breastfeeding.

Carefully:

With caution, Glaumax® is recommended for patients with aphakia, pseudoafacies, damage to the posterior capsule of the lens and known risk factors for the development of macular edema (in the treatment with latanoprost, cases of development of macular edema, including cystoid) are described.

Currently, there is no data on the use of Glaumax ® in inflammatory eye diseases, inflammatory, neovascular, occlusive and congenital glaucoma. There is little experience with the use of the drug in open-angle glaucoma in patients with artifacty, as well as in pigmentary glaucoma. Glaumax® has no or little effect on the pupil, but there is no evidence of the effect of the drug in acute attacks with closed-angle glaucoma. With these conditions, Glaumax® should be used with caution.

Pregnancy and lactation:

Studies on the use of the drug during pregnancy and lactation were not conducted. The use of Glaumax® during pregnancy is only possible 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.

If it is necessary to administer Glaumax® during lactation, it should be taken into account that latanoprost and its metabolites can penetrate into breast milk, so breastfeeding for the period of drug use should be discontinued.

Dosing and Administration:

In the conjunctival sac of the affected eye, instill 1 drop once a day, in the evening. When skipping the dose, the next one is administered in the usual mode (i.e., the dose is not doubled).

When prescribing a combination therapy, eye drops of various drugs should be administered at intervals of at least 5 minutes.

Side effects:

- From the side of the organ of vision

Allergic reactions from eyelids are possible. Less than 1% of patients may have the following manifestations: skin rash, allergic skin reactions on the eyelids, edema and hyperemia of the eyelids.

Less than 1% of patients are: edema and erosion of the cornea; irites, uveitis; macular edema, including cystic (mainly in patients with aphakia, pseudoafakia, damage to the posterior capsule of the lens or with risk factors for the development of macular edema).

More than 10% of patients have: eye irritation, eye pain, burning, itching, foreign body sensation after instillation, blurred vision, dotted epithelial keratopathy.

In 1-10% of patients there are: conjunctival hyperemia, transient point epithelial erosion, blepharitis, increased pigmentation of the iris, as well as darkening, thickening and lengthening of eyelashes, darkening of the skin of the eyelids; increase the number of eyelashes and change the direction of their growth.

In 1-4% of patients are possible: xerophthalmia, increased tear, pain / discomfort in the eyelids, photophobia.

Less than 1% of patients are: conjunctivitis, diplopia, retinal artery embolism, retinal detachment, vitreous hemorrhage (with diabetic retinopathy).

- From the musculoskeletal system:

The frequency is unknown: pain in the muscles, joints, back.

- From the respiratory system:

Frequency unknown: deterioration of the course of bronchial asthma, acute attack bronchial asthma, shortness of breath.

In 4% of patients: upper respiratory tract infection / cold / flu.

- From the side of the cardiovascular system:

In 1 - 2% of patients - chest pain / angina.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: irritation of the eye mucosa, conjunctival hyperemia or episclerosis.

Treatment: conduct symptomatic therapy.

Interaction:

Glaumax® has an additive effect in combination with beta-blockers (timolol), adrenomimetics (epinephrine), inhibitors of carbonic anhydrase (acetazolamide) and, to a lesser extent, with m-cholinomimetics (pilocarpine). Pharmaceutical interaction

The use of the drug is incompatible with eye drops containing thiomersal (precipitation occurs).

Special instructions:

Glaumax® 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 2 years of use of the drug are 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. Before starting treatment, patients should be informed about the possibility of changing eye color. In the case of an intense change in eye pigmentation, therapy is discontinued. Treatment of only one eye can lead to permanent heterochromia. In the presence of nevi or lentigo on the iris, their changes were not observed under the influence of therapy.

Perhaps darkening, thickening and lengthening of eyelashes, increasing their density and changing the direction of growth.

The preparation contains benzalkonium chloride, which can be absorbed by contact lenses. Before instilling eye drops contact lenses should be removed; to re-install the lenses can only 15-20 minutes after the 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:It should be borne in mind that against the background of therapy, a brief sensation of "swaddling" in front of the eyes may develop, therefore it is not recommended to drive vehicles or work with moving mechanisms within a few minutes after instillation of the drug.

Form release / dosage:Eye drops 0.005%.

Packaging:

2.5 ml sterile solution of latanoprost 0.005% in a 5 ml plastic bottle with a dropper and a cap; on 1 vial-dropper with the instruction on medical application in a pack from a cardboard.

Storage conditions:

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

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-000552

Date of registration:14.07.2011

Expiration Date:14.07.2016

The owner of the registration certificate:FARMSINTEZ, PAO FARMSINTEZ, PAO Russia

Manufacturer: & nbsp

KEVELT, AS Estonia

Information update date: & nbsp14.07.2016

Illustrated instructions

Instructions

Glaumax® (Glaumax)