Instructions for use: Daveris eye drops, solution 40 mcg/ml, dropper bottle 2.5 ml
Composition
active ingredient: travoprost;
1 ml of solution contains travoprost 40 mcg;
Excipients: boric acid, trometamol, macrogol glycerol hydroxystearate, disodium edetate, mannitol (E 421), benzalkonium chloride, hydrochloric acid or sodium hydroxide, purified water.
Dosage form
Eye drops, solution.
Main physicochemical properties: transparent colorless solution (not more opalescent than standard suspension I).
Pharmacotherapeutic group
Drugs for use in ophthalmology. Antiglaucoma drugs and miotics. Prostaglandin analogues.
ATX code S01E E04.
Pharmacological properties
Pharmacodynamics.
Travoprost, a prostaglandin F2α analogue, is a full, selective agonist with high affinity for prostaglandin FP receptors, and reduces intraocular pressure by increasing the outflow of aqueous humor through the trabecular meshwork and uveoscleral pathways. The onset of intraocular pressure reduction in humans begins approximately 2 hours after administration, with a maximum effect occurring 12 hours later. The significant reduction in intraocular pressure following a single dose can be maintained for more than 24 hours.
Pharmacokinetics.
Travoprost is an ester prodrug. It is absorbed through the cornea, where the isopropyl ester is hydrolyzed to the active free acid.
The maximum concentration (Cmax) in blood plasma is reached within 30 minutes after topical application and is 25 pg/ml or less. It is rapidly eliminated from plasma, and within an hour the concentration decreases below the detection threshold (less than 10 pg/ml).
Metabolism is the major route of elimination of travoprost and travoprost free acid. The systemic metabolic pathways parallel those of endogenous prostaglandin F2α and are characterized by reduction of the 13-14 double bond, oxidation of the 15-hydryl group, and β-oxidative cleavage of the upper side chain. Travoprost free acid and its metabolites are primarily excreted by the kidneys.
No dose adjustment is required for patients with mild to severe hepatic impairment or mild to severe renal impairment (creatinine clearance below 14 ml/min).
Indication
Reduction of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Contraindication
Hypersensitivity to the active substance or to other components of the drug.
Interaction with other medicinal products and other types of interactions
There have been no reports of drug interaction studies, however, clinically significant interactions with other drugs are not expected.
Specific in vitro interaction studies of travoprost and thiomersal-containing products have been reported. No evidence of precipitation was observed.
Application features
The drug may gradually change eye color by increasing the number of melanosomes (pigment granules) in melanocytes. Before starting treatment, patients should be informed of the possibility of irreversible changes in eye color. Treatment of one eye may cause irreversible heterochromia. The long-term effects and consequences of long-term exposure to melanocytes are currently unknown. The change in iris color occurs slowly and may be unnoticed for several months or even years. This effect is mainly observed in patients with mixed iris color (e.g., blue-brown, gray-brown, green-brown or yellow-brown), but this phenomenon has also been observed in patients with brown eyes. Usually, brown pigmentation around the pupil spreads concentrically to the periphery of the iris of the affected eye, but the entire iris or parts of it may acquire a more intense brown color. After stopping treatment, no further increase in brown pigment in the iris was observed.
Darkening of the eyelid skin and/or periorbital area has been reported in association with the use of travoprost in 0.4% of patients.
Daveris may gradually change the structure of the eyelashes of the eye in which it is used (increasing the length, thickness, pigmentation and/or number of eyelashes). The mechanism of the change in the structure of the eyelashes and the long-term consequences of this action are currently unknown.
There is no experience with the use of the drug in inflammatory eye diseases, neovascular glaucoma, angle-closure glaucoma, narrow-angle or congenital glaucoma. Experience with eye diseases caused by thyroid dysfunction, open-angle glaucoma in patients with pseudophakia, pigmentary or pseudoexfoliative glaucoma is limited.
Macular edema has been reported during treatment with prostaglandin F2α analogues.
Contact of Daveris with the skin should be avoided, as studies in rabbits have been reported in which transdermal absorption of travoprost has been demonstrated.
Caution should be exercised when prescribing Daveris to patients with risk factors for iritis/uveitis.
Prostaglandins and their analogues are biologically active materials that can be absorbed through the skin. Therefore, pregnant women and women who intend to become pregnant should take appropriate precautions to prevent direct exposure to the contents of the vial. In the event of accidental skin contact with a significant amount of the solution, the affected area should be washed immediately and thoroughly.
Changes in the periorbital area and eyelid skin, including deepening of the palpebral sulcus, have been observed with the use of prostaglandin analogues.
Contact lenses should be removed before instillation of the drug and should not be put back in earlier than 15 minutes after application of the drug.
Use during pregnancy or breastfeeding
Travoprost has harmful pharmacological effects on pregnant women and/or the fetus/newborn child, therefore Daveris should not be used during pregnancy unless absolutely necessary.
There are no data on the effects of travoprost on human reproductive function. Animal studies have been reported in which travoprost at a dose 250 times the maximum recommended ophthalmic dose did not have any harmful effects on reproductive function.
Daveris should not be used in women of childbearing potential not using contraception.
It is not known whether travoprost from eye drops is excreted in human milk. Animal studies have been reported to show that travoprost and its metabolites are able to pass into human milk. Use of the drug during breastfeeding is not recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
As with any eye drops, temporary blurred vision or other visual disturbances may affect your ability to drive or use machines. If blurred vision occurs immediately after instillation, you should wait until your vision clears before driving or using machines.
Method of administration and doses
For topical use.
Use in the treatment of adults, including elderly patients
1 drop of Daveris in the conjunctival sac of the affected eye once a day. The optimal effect is achieved when the dose is administered in the evening.
Nasolacrimal occlusion or slight eyelid closure is recommended after instillation. This reduces systemic absorption of drugs administered into the eye, which may reduce the likelihood of systemic side effects.
If more than one topical ophthalmic agent is used, the interval between their applications should be at least 5 minutes (see section “Interaction with other medicinal products and other types of interactions”).
If a dose is missed, treatment should be continued with the next scheduled dose. The daily dose should not exceed one drop in the affected eye once a day.
If another ophthalmic antiglaucoma agent is being replaced with Daveris, the other drug should be discontinued and Daveris should be started the next day.
Use in liver and kidney dysfunction
No dose adjustment is necessary.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip.
Children.
The safety and efficacy of the drug in patients under 18 years of age have not been established, therefore the drug should not be used in this category of patients.
Overdose
There have been no reports of overdose. Local overdose is unlikely to cause or be associated with toxic effects. In case of local overdose with Daveris, the eye(s) should be flushed with warm water. In case of accidental ingestion, symptomatic and supportive therapy should be administered.
Adverse reactions
Frequency of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100) and rare (≥1/10000 to <1/1000).
Infections and infestations
Uncommon: herpes simplex, herpetic keratitis.
On the part of the immune system
Uncommon: hypersensitivity, drug hypersensitivity, seasonal allergy.
From the nervous system
Uncommon: visual field disturbances, headache.
Uncommon: dizziness, dysgeusia.
Ophthalmological disorders
Very common: conjunctival hyperemia, ocular hyperemia.
Uncommon: corneal erosion, punctate keratitis, keratitis, iritis, decreased visual acuity, conjunctivitis, anterior chamber inflammation, blepharitis, blurred vision, photophobia, cataract, periorbital edema, eyelid pruritus, eye discharge, eyelid margin scaling, lacrimation increased, eyelid erythema, eyelash growth, macular degeneration, eye swelling, corneal discoloration, photopsia, corneal epithelial defect, halo around light source, corneal pigmentation, allergic conjunctivitis, conjunctival disorders, meibomianitis, ectropion, keratoconjunctivitis sicca, dry eye syndrome, pigment dispersion syndrome, eyelid pain, dark circles under the eyes, eyelid disorder, scleral hyperemia.
Uncommon: uveitis, iridocyclitis, conjunctival follicles, conjunctival edema, ocular hypoesthesia, ocular inflammation, eyelid eczema, anterior chamber pigmentation, asthenopia, ocular allergy, eyelid irritation, eyelash discoloration, eyelash thickening.
Cardiovascular system
Uncommon: irregular heartbeat, decreased blood pressure, increased blood pressure, hypotension.
Rare: decreased heart rate, palpitations, hypertension.
Respiratory, thoracic and mediastinal disorders
Uncommon: respiratory disorders, dysphonia, nasal congestion, throat irritation.
Rare: asthma, dyspnea, cough, sore throat, nasal discomfort, nasal dryness.
From the digestive system
Uncommon: exacerbation of peptic ulcer, gastrointestinal disorders.
Rare: dry mouth, constipation.
Skin and subcutaneous tissue disorders
Uncommon: skin hyperpigmentation (around the eye), allergic dermatitis, contact dermatitis, erythema, rash, hair structure disorder.
Rare: skin discoloration, hypertrichosis, madarosis, hair color changes.
Musculoskeletal, connective tissue, bone disorders
Uncommon: musculoskeletal pain.
General disorders and disorders related to the method of administration of the drug
Uncommon: malaise.
Rare: asthenia.
Additional adverse reactions have also been reported, but the frequency of their occurrence cannot be estimated from the available data. Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Mental disorders: depression, anxiety.
Ophthalmological disorders: macular edema, sunken eyes.
From the side of the organs of hearing and balance: tinnitus.
Cardiac: chest pain.
On the part of the digestive system: diarrhea, stomach pain, nausea.
Skin and subcutaneous tissue disorders: itching.
Musculoskeletal and connective tissue disorders: arthralgia.
Renal and urinary disorders: dysuria, urinary incontinence.
Laboratory tests: increased PSA (prostate-specific antigen) levels.
General disorders: bradycardia, tachycardia, worsening of asthma, vertigo, abnormal hair growth.
Expiration date
3 years. After opening the bottle, the drug can be used within 28 days.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
2.5 ml in a dropper bottle; 1 dropper bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
K.O. Rompharm Company SRL / SC Rompharm Company SRL
Location of the manufacturer and its business address
Otopeni city, Eroilor str. № 1A, 075100, jud. Ilfov, Romania.
Applicant
WORLD MEDICINE LTD / WORLD MEDICINE LTD.
