Instructions Monoprost eye drops solution 50 mcg/ml container 0.2 ml in sachet No. 30
Composition
active ingredient: latanoprost;
1 ml of eye drop solution contains 50 mcg of latanoprost;
1 drop contains about 1.5 mcg of latanoprost;
Excipients: polyethoxylated hydrogenated castor oil; sorbitol (E 420), carbomer, macrogol 4000, disodium edetate, sodium hydroxide, water for injections.
Dosage form
Eye drops, solution.
Main physicochemical properties: opalescent solution, practically free of particles. The solution is slightly yellow, pH 6.5–7.5, osmolality 250–310 mosmol/kg.
Pharmacotherapeutic group
Ophthalmic preparations. Antiglaucoma preparations and miotics. Prostaglandin analogues. ATX code S01E E01.
Pharmacological properties
Pharmacodynamics
The active substance latanoprost, a prostaglandin F2α analogue, is a selective agonist of the prostanoid FP receptor, which reduces intraocular pressure by increasing the outflow of aqueous humor. The reduction in intraocular pressure in humans begins approximately 3–4 hours after administration of the drug, and the maximum effect is achieved after 8–12 hours. The hypotensive effect lasts for at least 24 hours.
The drug is effective as monotherapy. In addition, latanoprost is effective in combination with beta-blockers (timolol). The effect of latanoprost is additive when used in combination with adrenergic agonists (epinephrine dipivalyl), oral carbonic anhydrase inhibitors (acetazolamide) and at least partially additive when used with cholinergic agonists (pilocarpine).
Latanoprost does not significantly affect the production of intraocular fluid. No effect of latanoprost on the blood-ophthalmic barrier has been found.
Latanoprost did not cause fluorescein leakage in the posterior segment of the human eye in pseudophakia.
It has been proven that latanoprost in therapeutic doses has no pharmacological effect on the cardiovascular and respiratory systems.
Pharmacokinetics
Latanoprost is a prodrug. Its isopropyl ester, which is inactive in itself, is absorbed through the cornea when instilled into the eye and hydrolyzed by corneal esterases to an acid that has a biologically active effect.
Maximum concentration in the intraocular fluid is reached approximately 2 hours after topical administration. Latanoprost is distributed mainly in the anterior segment, conjunctiva and eyelids. Only a small amount of the drug reaches the posterior segment.
It is practically not metabolized in the eye. The main metabolism of the drug occurs in the liver. The plasma half-life is 17 minutes.
Indication
For the reduction of elevated intraocular pressure in adult patients, including elderly patients with open-angle glaucoma and elevated intraocular pressure.
Contraindication
Known hypersensitivity to any component of the drug.
Interaction with other medicinal products and other types of interactions
There is insufficient data on the interaction of latanoprost with other drugs.
Paradoxical increases in intraocular pressure have been reported following concomitant topical ocular administration of two prostaglandin analogues. Therefore, the concomitant use of two or more prostaglandins, prostaglandin analogues or their derivatives is not recommended.
Drug interaction studies have only been conducted in adult patients.
Application features
Latanoprost may cause a gradual change in eye color by increasing the amount of brown pigment in the iris. Patients should be informed of the possibility of permanent eye color change before treatment is initiated. Treatment of only one eye may result in permanent heterochromia.
The color change is due to an increase in melanin content in the stromal melanocytes of the iris, and not to 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. There is no evidence 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. No accumulation of pigment was observed in the trabecular meshwork or in any other part of the anterior chamber of the eye. Increased pigmentation of the iris does not cause clinical complications, and the use of the drug can be continued if there is a change in iris pigmentation. However, patients should undergo regular examinations and, if the clinical situation requires it, discontinue treatment with the drug.
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. MONOPROST® 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, it is recommended to use the drug with caution in such conditions.
Data on the use of the drug during the perioperative period in cataract surgery are limited. The drug should be used with caution in such patients.
The drug should be used with caution in patients with a history of herpetic keratitis. In case of active keratitis caused by the herpes simplex virus, in patients with a history of recurrent herpetic keratitis, especially associated with prostaglandin analogues, the drug should be avoided.
Reports of macular oedema have mainly concerned (see section 4.8) aphakic patients, pseudophakic patients with a tear in the posterior lens capsule or anterior chamber, or patients with known risk factors for cystoid macular oedema (such as diabetic retinopathy and retinal vein occlusion).
Therefore, the drug should be used with caution in the above-mentioned patients.
The drug should be used with caution in patients with known risk factors for iritis/uveitis.
Experience in patients with bronchial asthma is limited, although some cases of exacerbation of bronchial asthma and/or dyspnoea have been reported. The drug should be administered with caution to patients with bronchial asthma, see also section "Adverse reactions".
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 resolves with continued treatment.
Latanoprost may gradually change the eyelashes and vulva around the injected eye and in surrounding areas; these changes include increased length, thickness, pigmentation, and number of hairs in the eyelashes or vulva, as well as growth of eyelashes in the wrong direction. Changes in eyelashes are reversible and disappear after stopping the drug.
MONOPROST® contains macrogolglycerol hydroxystearate (polyethoxylated hydrogenated castor oil) and may cause allergic skin reactions, see section “Adverse reactions”. There is currently insufficient safety data on this excipient in the event of long-term use.
Use during pregnancy or breastfeeding
Fertility.
Animal studies have not revealed any effect of latanoprost on reproductive function in either sex.
Pregnancy.
The safety of this medicinal product 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 newborn. Therefore, the drug should not be used during pregnancy.
Breast-feeding.
Latanoprost and its metabolites may pass into breast milk, therefore, nursing mothers should discontinue treatment with the drug or refrain from breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
MONOPROST® has a minor effect on the speed of reaction when driving or using other mechanisms. As with the use of other drugs, instillation of eye drops may cause temporary blurred vision.
Until this effect has resolved, patients should not drive or operate machinery until visual acuity returns.
Method of administration and doses
The recommended dose for adults, including the elderly, is 1 drop in the affected eye once daily. The optimal effect is achieved when the drug is used in the evening.
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 for 1 minute. This should be done immediately after instilling each drop.
Contact lenses should be removed before instilling eye drops. They can be reinserted after 15 minutes.
When using multiple topical ophthalmic agents, the drugs should be applied at least 5 minutes apart.
Instructions for use:
Wash your hands, stand or sit comfortably.
Pull the lower eyelid of the affected eye down with your finger.
Bring the edge of the open single-dose container as close to the eye as possible, but do not touch the ocular surface.
Gently squeeze the container to release one drop into your eye and release your lower eyelid.
Close your eyes and press your finger against the inner corner of the instilled eye for 1 minute.
Repeat all of the above steps with the other eye, if prescribed by your doctor.
A single-dose container with any remaining contents should be discarded immediately after use. Do not store for future use.
Children
Do not use in children (under 18 years of age).
Overdose
Apart from eye irritation and conjunctival hyperemia, no other ocular side effects have been reported with overdose of the drug.
The following information may be useful in the event of accidental ingestion. One vial contains 10 mcg of latanoprost. More than 90% of it is metabolized during the first pass through the liver. Intravenous infusion of the drug at a dose of 3 mcg/kg to healthy volunteers did not cause any symptoms, but at a dose of 5.5–10 mcg/kg it caused nausea, abdominal pain, dizziness, increased fatigue, hot flashes and sweating.
When topically applied to the eyes, doses of latanoprost that are 7 times higher than the clinical dose of the drug were administered, bronchostenosis was not observed in patients with moderate bronchial asthma.
In case of overdose, symptomatic treatment should be carried out.
Adverse reactions
Most adverse reactions are related to the eyes. Increased iris pigmentation has been reported with latanoprost. Other adverse reactions are usually transient and occur only during instillation.
Infectious and parasitic diseases: herpetic keratitis*§.
Nervous system: headache*, dizziness*.
On the part of the organs of vision: increased pigmentation of the iris; mild or moderate conjunctival hyperemia; eye irritation (burning sensation with a feeling of "sand in the eyes", itching, tingling or a feeling of a foreign body in the eye); changes in eyelashes and vellus hair (increase in length, thickness, pigmentation and number); punctate keratitis, mostly asymptomatic; blepharitis; eye pain; photophobia; eyelid edema; dry eyes; keratitis*; blurred vision; conjunctivitis*; iritis*; uveitis*; macular edema, including cystic macular edema*; corneal edema*; corneal erosions; periorbital edema; trichiasis* (growth of eyelashes in the wrong direction, sometimes leading to eye irritation); distichiasis (the appearance of an additional row of eyelashes near the excretory ducts of the meibomian glands), local skin reaction on the eyelids; Periorbital and eyelid changes leading to deepening of the eyelid fold; Iris cyst*§; Darkening of the palpebral skin of the eyelids; Pseudopemphigoid of the conjunctiva of the eye*§.
Cardiac disorders: angina pectoris*, unstable angina pectoris, palpitations*.
Respiratory, thoracic and mediastinal disorders: wheezing*, exacerbation of bronchial asthma, shortness of breath*.
Gastrointestinal: nausea*, vomiting*.
Skin and subcutaneous tissue disorders: skin rash, itching.
Musculoskeletal and connective tissue disorders: myalgia*, arthralgia*.
General disorders and administration site conditions: chest pain*.
Note
* Adverse drug reaction identified in the post-marketing period.
The frequency of adverse drug reactions was assessed using the “Rule of Three”.
Notification of possible adverse reactions
Reporting of suspected adverse reactions after the marketing authorisation of a medicinal product is essential. This allows for continuous monitoring of the risk/benefit balance of the medicinal product. Any suspected adverse reactions should be reported to qualified healthcare professionals.
Please send information to: info@regata.in.ua or by phone: (044) 467-57-70 (24 hours), 585-04-60.
Expiration date
2 years when stored in the outer packaging.
After first opening the sachet, use single-dose containers within 10 days.
After first opening the single-dose container, the contents should be used immediately and the single-dose container should be discarded.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
0.2 ml in a single-dose container; 5 single-dose containers connected together in a strip in a sachet; 6 sachets (No. 30) in a cardboard box.
Vacation category
According to the recipe.
Producer
EXCELVISION.
27 rue de la Lombardiere, ANNONAY, 07100, France/27 rue de la Lombardiere, ANNONAY, 07100, France
Applicant
LABORATORY THEA/LABORATOIRES THEA.
Location of the applicant and/or applicant's representative
12 rue Louis Bleriot 63100 CLERMONT-FERRAND CEDEX 2, France/12 rue Louis Bleriot 63100 CLERMONT-FERRAND CEDEX 2, France
