Instructions Latanox eye drops 0.05 mg/ml dropper bottle 2.5 ml
Composition
active ingredient: latanoprost;
1 ml of the drug contains latanoprost - 0.05 mg;
Excipients: benzalkonium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate anhydrous, sodium chloride, purified water.
Dosage form
Eye drops.
Main physicochemical properties: colorless transparent liquid.
Pharmacotherapeutic group
Antiglaucoma drugs and miotics. Latanoprost. ATX code S01E E01.
Pharmacological properties
Pharmacodynamics
Latanoprost is a prostaglandin F2α analogue and a selective FP receptor agonist. It reduces intraocular pressure by increasing aqueous humor outflow and exhibits antiglaucoma activity. The main mechanism of action of latanoprost is associated with an increase in uveoscleral outflow. It does not show a significant effect on aqueous humor production and does not affect the blood-ophthalmic barrier. The reduction in intraocular pressure begins 3-4 hours after administration of the drug, the maximum effect is observed after 8-12 hours. The hypotensive effect lasts for at least 24 hours.
Studies have shown that latanoprost is effective as monotherapy. In addition, clinical studies of the combination use of the drug have been conducted. These included studies that showed that latanoprost is effective in combination with beta-blockers (timolol). Short-term (1 or 2 weeks) studies show that the effect of latanoprost is additive when used in combination with adrenergic agonists (dipivalyl epinephrine), oral carbonic anhydrase inhibitors (acetazolamide) and at least partially additive when used with cholinergic agonists (pilocarpine).
Clinical studies have shown that latanoprost does not significantly affect the production of intraocular fluid. No effect of latanoprost on the blood-ophthalmic barrier was detected.
Latanoprost did not cause fluorescein leakage in the posterior segment of human pseudophakic eyes during short-term treatment.
No significant pharmacological effects of latanoprost at clinical doses on the cardiovascular and respiratory systems were detected.
Pharmacokinetics
Latanoprost (molecular weight 432.58) is the isopropyl ester of the active substance, i.e. a prodrug that is inactive in itself, but after hydrolysis to form latanoprost acid, it becomes biologically active.
Prodrugs penetrate the cornea well, and all drugs that enter the intraocular fluid are hydrolyzed while passing through the cornea.
Studies in humans have shown that maximum concentrations in the intraocular fluid are reached approximately 2 hours after topical administration. After topical administration in monkeys, latanoprost is distributed mainly in the anterior segment, conjunctiva and eyelids. Only a small amount of the drug reaches the posterior segment.
Latanoprost acid is practically not metabolized in the eye. The main metabolism of the drug occurs in the liver. In humans, the plasma half-life is 17 minutes.
Indication
To reduce elevated intraocular pressure in patients with open-angle glaucoma and increased ophthalmotonus.
Contraindication
Individual hypersensitivity to latanoprost, benzalkonium chloride or other components of the drug.
Interaction with other medicinal products and other types of interactions
There are no comprehensive data on interactions with other medicinal products. Paradoxical increases in intraocular pressure have been reported following concomitant ocular administration of two prostaglandin analogues. Therefore, the concomitant use of two or more prostaglandins, prostaglandin analogues or their derivatives is not recommended.
Application features
This change in eye colour is observed mainly in patients with mixed iris colour, e.g. blue-brown, grey-brown, yellow-brown or green-brown. In studies with latanoprost, the onset of colour change usually occurred within the first 8 months of treatment, rarely during the second or third year and was not observed after the fourth year of treatment. The progression of iris pigmentation decreases over time and stabilises after 5 years. The effect of increased pigmentation after 5 years of treatment with the drug has not been evaluated. In an open-label 5-year safety study with latanoprost, 33% of patients were reported to have increased iris pigmentation. Changes in iris colour are in most cases minor and often clinically unnoticeable. The incidence in patients with mixed iris colour ranged from 7% to 85%, with patients with yellow-brown iris colour having the highest incidence. Changes in eye color were not observed in patients with uniform blue eyes and were rare in patients with uniform gray, green, or brown eyes. The color change is due to an increase in melanin content in the stromal melanocytes of the iris, not an increase in the number of melanocytes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the affected eye, but the entire iris or parts of it may become more brown. After discontinuation of treatment, no further increase in brown pigmentation of the iris has been observed. To date, there is no evidence in clinical studies that this phenomenon is associated with any symptoms or pathological changes.
In the presence of nevi or freckles on the iris, no changes were noted under the influence of therapy. In clinical studies, no accumulation of pigment was observed in the trabecular meshwork or in any other part of the anterior chamber of the eye. The results of 5 years of clinical use of the drug indicate that increased iris pigmentation does not cause clinical complications and the use of Latanox® can be continued in the event of a change in iris pigmentation. However, patients should undergo regular examinations and, if the clinical situation requires it, treatment with Latanox® should be discontinued.
Experience with latanoprost is limited in chronic angle-closure glaucoma, open-angle glaucoma in patients with pseudophakia, and pigmentary glaucoma. There are currently no data on the use of latanoprost in inflammatory and neovascular glaucoma or in inflammatory eye diseases. Latanoprost has no or negligible effect on the pupil, but there are no data on the use of the drug in acute attacks of angle-closure glaucoma. Therefore, Latanoprost® is recommended to be used with caution in such conditions until more data are available.
There are limited data on the use of latanoprost in the perioperative period of cataract surgery. Latanoprost should be used with caution in such patients.
Latanox® should be used with caution in patients with a history of herpetic keratitis, but its use should be avoided in cases of active keratitis caused by the herpes simplex virus and in patients with a history of recurrent herpetic keratitis, especially associated with prostaglandin analogues.
Cases of macular edema have been reported, mainly in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, and in patients with known risk factors for cystoid macular edema (such as diabetic retinopathy and retinal vein occlusion).
Latanox® should be used with caution in such patients.
Latanox® can be used with caution and under supervision in patients with known risk factors for the development of iritis/uveitis.
Experience in patients with bronchial asthma is limited, although some cases of exacerbation of bronchial asthma and/or dyspnea have been reported in the post-marketing period. Until sufficient clinical experience has been gained, the drug should be prescribed with caution to patients with bronchial asthma.
Periorbital skin discoloration has been observed, with the majority of cases occurring in Japanese patients. Currently available data suggest that periorbital skin discoloration is not permanent and in some cases has resolved with continued treatment with the medicinal product.
Latanox® contains benzalkonium chloride, which is often used as a preservative in ophthalmic preparations. Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy, and may also cause eye irritation and discoloration of soft contact lenses. Patients with dry eyes or diseases that damage the cornea should be closely monitored during frequent or prolonged use of latanoprost. Contact lenses may absorb benzalkonium chloride and should be removed before using latanoprost, but may be reinserted 15 minutes later.
Use during pregnancy or breastfeeding
The safety of latanoprost for use in pregnant women has not been established. Its pharmacological action poses a potential risk to the course of pregnancy, to the fetus or to the newborn. Latanox® should not be used during pregnancy.
Latanoprost and its metabolites may pass into breast milk, therefore, nursing mothers should discontinue treatment with Latanoprost® or discontinue breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
Patients who experience temporary loss of vision after using eye drops are advised not to drive or operate other machinery for several minutes after instillation of the drug.
Method of administration and doses
Recommended dose for adults, including the elderly
Recommended therapy: 1 drop in the affected eye once a day. The optimal effect is achieved when Latanox® is used in the evening.
Latanox® should not be used more often than once a day, as more frequent use has been shown to decrease the effectiveness of lowering intraocular pressure.
If a dose is missed, treatment should be continued by taking the next dose at the usual time.
As with any eye drops, to reduce possible systemic absorption during instillation, it is recommended to compress the lacrimal sac in the medial canthus of the eye for 1 minute (punctal occlusion). This should be done immediately after instillation of each drop.
Contact lenses should be removed before instilling eye drops and can be reinserted after 15 minutes.
When using multiple topical ophthalmic agents, the drugs should be applied at least 5 minutes apart.
Children
There is insufficient experience with the use of Latanox® in children.
Latanox® is not recommended for use in pediatric practice.
Overdose
Apart from eye irritation and conjunctival hyperemia, no other ocular side effects have been reported with overdose. The following information may be useful in the event of accidental ingestion of Latanox®: one vial contains 125 mcg of latanoprost. More than 90% is metabolized during the first pass through the liver. Intravenous infusion of the drug at a dose of 3 mcg/kg to healthy volunteers caused an increase in mean plasma concentrations that were 200 times higher than the concentrations in clinical trials and did not cause any symptoms. However, at a dose of 5.5-10 mcg/kg, nausea, abdominal pain, dizziness, fatigue, flushing and increased sweating were observed. In monkeys, intravenous infusion of latanoprost at doses up to 500 mcg/kg did not cause any significant effects on the cardiovascular system. Intravenous administration of latanoprost in monkeys was associated with transient bronchospasm.
However, when topically applied to the eyes at doses of latanoprost 7 times the clinical dose of Latanox®, bronchoconstriction was not observed in patients with moderate bronchial asthma. In case of overdose with Latanox®, symptomatic treatment should be carried out.
Side effects
Adverse reactions are classified according to their frequency as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000) and very rare (< 1/10000), not known (cannot be determined based on available data).
Infectious and parasitic diseases
Not known: herpetic keratitis.
From the organs of vision
Very common: increased pigmentation of the iris; mild to moderate conjunctival hyperemia, eye irritation (burning sensation with a feeling of "sand in the eyes", itching, tingling and foreign body sensation in the eye); changes in eyelashes and vellus hair (increase in length, thickness, pigmentation and number) (the vast majority of cases were observed in Japanese patients).
Common: transient punctate epithelial erosions, mostly asymptomatic; blepharitis; eye pain; photophobia.
Uncommon: eyelid edema; dry eyes; keratitis; blurred vision; conjunctivitis.
Rare: iritis/uveitis, macular edema; symptomatic corneal edema and erosions; periorbital edema; growth of eyelashes in the wrong direction, sometimes leading to eye irritation; appearance of an extra row of eyelashes near the meibomian gland ducts (distichiasis), photophobia.
Very rare: periorbital and eyelid changes leading to deepening of the eyelid crease.
Not known: iris cyst.
From the nervous system
Not known: headache, dizziness.
Very rare: worsening of angina pectoris in patients with pre-existing disease.
Not known: rapid heartbeat.
Respiratory system
Rare: bronchial asthma, exacerbation of bronchial asthma and dyspnoea.
Skin and subcutaneous tissue disorders
Uncommon: skin rash.
Rare: local skin reaction on the eyelids; darkening of the palpebral skin of the eyelids.
Musculoskeletal and connective tissue disorders
Not known: myalgia, arthralgia.
Gastrointestinal tract
Uncommon: nausea, vomiting.
General disorders and administration site conditions
Very rare: chest pain.
Cases of corneal calcification in association with the use of phosphate-containing eye drops have been reported very rarely in some patients with significantly damaged corneas.
Expiration date
2 years.
Storage conditions
Store at a temperature of +2°C to +8°C, protected from light and out of the reach of children.
Store the opened bottle at a temperature not exceeding 25 °C for four weeks.
Packaging
2.5 ml of solution in a dropper bottle; 1 or 3 dropper bottles in a cardboard box.
Vacation category
According to a doctor's prescription.
Producer
Jadran-Galensky Laboratories, Dr.
Location of the manufacturer and its business address
Svilno 20, 51000 Rijeka, Croatia.
