Expiration date: 02/2025
Clinico-pharmacological group
(Protivoglaucomny drug)
Release form, composition and packaging
Eye drops 0.005% transparent, colorless.
1 ml contains:
latanoprost 50 micrograms
Excipients: sodium dihydrogen phosphate dihydrate 3.98 mg/ml, sodium chloride 5.69 mg/ml benzalkonium chloride 0.2 mg/ml, disodium hydrogen phosphate anhydrous 3.48 mg/ml, water d/and up to 1 ml. 2.5 ml dropper bottle polymer (1) - packs of cardboard.
Pharmacological action
Latanoprost is an active ingredient of the drug Powmax, is an analogue of prostaglandin F2a and selective agonist of the prostaglandin F(FP) receptors. The drug has protivoglaucomnoe action. The primary mechanism of action of the drug is associated with an increase in uveoscleral outflow. Reduces intraocular pressure by increasing outflow of aqueous through the vascular membrane of the eyeball. The drug has no significant effect on products watery moisture and gematoentsefalichesky barrier may slightly change the size of the pupil. After the injection, intraocular pressure reduction starts after 3-4 h, the maximum effect is reached after 8-12 h, the effect lasts for at least 24 hours
Pharmacokinetics
Satyanarayana penetrates well into the cornea, thus there is latanoprost hydrolysis to the biologically active form - latanoprost-acid. The maximum concentration latanoprosta in watery moisture is approximately 2 h after local application of the drug.Raspredelitelnaya no effect on products watery moisture, and has the effect of lowering intraocular pressure by increasing outflow of intraocular. The maximum concentration latanoprosta in watery moisture is achieved 2 hours after application. The volume of distribution latanoprost is 0.16 ± 0.02 l/kg. Latanoprost-acid, detectable shortly after treatment, is the most significant metabolite latanoprost and determined in watery moisture during the first 4 hours and in plasma only during 1 hours after topical application. In the tissues of the eye latanoprost acid undergoes no further transitions, but after moving into the systemic circulation is extensively metabolized.Metabolism and wavegeneration latanoprost occurs mainly in the liver. T1/2???????????? is 17 min. The major metabolites, 1,2-dinor - and 1,2,3,4-tetranor-metabolites have no or weak biological activity. The final latanoprost metabolites are excreted mainly by the kidney: urine output approximately 88% of the administered dose latanoprost.
Dosage
In the conjunctival SAC of the affected eye instilled 1 drop of 1 times/day, in the evening. Skip the next dose is administered in normal mode (i.e. dose double).Prescribing combination therapy eye drops of various drugs should be administered at intervals of not less than 5 min. With caution it is recommended to apply Glomax patients with aphakia, pseudophakia, damage to the posterior lens capsule and known risk factors for macular edema (when treating latanoprost described cases of macular edema, including cystoidea).Currently, there are no data on the drug Glumac in inflammatory eye diseases, inflammatory, neovascular, angle-closure and congenital glaucoma. There is little experience in the use of the drug in open angle glaucoma patients with artificial and in pigmentary glaucoma. Powmax has no or has little effect on the pupil, however, no data on the effect of the drug during an acute attack when angle-closure glaucoma. For these conditions to apply Glomax careful
Overdose
Symptoms: irritation of eyes, redness of the conjunctiva or episclera.Treatment: symptomatic therapy.Vzaimodeistviyami drug has an additive effect in combination with beta-blockers (timolol), adrenergic agonists (epinephrine), carbonic anhydrase inhibitors (acetazolamide) and, to a lesser extent, with m-cholinomimetics (pilocarpine).The drug is incompatible with eye drops containing thiomersal (precipitation occurs).Pregnancy and lactoseintolerance for use of the drug during pregnancy and lactation have not been conducted. The use of the drug Glomax when pregnancy is possible only under the supervision of a physician and only if the expected benefit to the mother outweighs the risk of possible side effects in the fetus.If necessary, the appointment of the drug Glomax lactation should be taken into account that latanoprost and its metabolites can penetrate into breast milk, so breastfeeding on the period of use of the drug should be discontinued.
Side effects
On the part of the organ of vision: possible allergic reactions of the eyelids. Less than 1% of patients may have the following manifestations: skin rash, allergic skin reactions on the eyelids, swelling and redness of the eyelids.Less than Y1 % of patients are: swelling and erosion of the cornea, irity, uveitis, macular edema, including and cystic (mainly in patients with aphakia, pseudophakia, damage to the posterior lens capsule, or risk factors for development of macular edema).More than 10% of patients occur: eye irritation, eye pain, burning, itching, foreign body sensation after the installation, blurred vision, epithelial keratopathy point.From 1-10% of patients are: conjunctival hyperaemia, transient point epithelial erosion, blepharitis, increased pigmentation of the iris, and darkening, thickening and elongation of lashes, darkening of the eyelid skin increasing the number of eyelashes and their growth.Have 1-4% of patients: prevalence, increased lacrimation, pain/discomfort of the eyelids, photophobia.Less than 1% of patients are: conjunctivitis, diplopia, embolism of the arteries of the retina, detachment of retina, bleeding in vitreous (diabetic retinopathy).From the side of musculoskeletal system: frequency unknown: pain in muscles, joints, back.The respiratory system: frequency not known: worsening of bronchial asthma acute attack of bronchial asthma, shortness of breath.4% of patients: infections of the upper respiratory tract/common cold/flu.From cardiovascular system: in 1-2% of patients - chest pain/angina.
Terms and conditions storage
Keep the preparation in a protected from light place at temperature from 2 to 8°C. Opened vial is stored at temperatures not above 25°C. Keep out of reach of children.Shelf life - 2 years.After opening the bottle the drug should be used within 4 weeks. Do not use after the expiry date printed on the package.
Testimony
Reduction of intraocular pressure in patients with open-angle glaucoma with elevated IOP.
Contraindications
— hypersensitivity to latanoprost, benzalkonium chloride or other ingredients of the drug, the age of 18, the period of lactation.
Special instructions
Powmax can cause gradual change in eye color by increasing the amount brown pigment in the iris. This effect is revealed mainly in patients with mixed colour irides, such as blue-brown, gray-brown, green-brown or yellow-brown, which is due to increased melanin content in stromal melanocytes of the iris. Usually brown pigmentation extends concentrically around the pupil to the periphery of the iris of the eye, the entire iris or parts of it could become more intense brown color. In patients with a uniformly colored eyes of blue, gray, green or brown color change of eyes after 2 years of using the drug are observed very rarely. The color change is not accompanied by any clinical symptoms or pathological changes. After the drug was observed a further increase in the number of brown pigment, but has developed the color change may be irreversible. Before starting treatment patients should be informed about the possibility of changing eye color. In case of intensive changes in the pigmentation of the eye therapy is stopped. Treatment only one eye may result in permanent heterochromia. In the presence of nevi or lentigines on the iris is not noted their changes under the influence of therapy.There may be a darkening, thickening and lengthening of eyelashes, increasing their thickness and modifying the direction of growth.The product contains benzalkonium chloride which may be absorbed by contact lenses. Before the instillation of eye drops contact lenses should be removed, re-installed the lenses only after 15-20 minutes after installation of the drug. Be aware that the therapy may develop a momentary feeling of "veil" before the eyes, so it is not recommended to drive vehicles or operate moving machinery for several 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.
