Instructions for use: Cataxol eye drops solution 15 mg/ml dropper bottle 15 ml
Composition
active ingredient: sodium azapentacene polysulfonate;
1 ml of solution contains 0.15 mg of sodium azapentacene polysulfonate;
Excipients: disodium tetraborate decahydrate, boric acid, potassium chloride, thiomersal, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium hydroxide solution, water for injections.
Dosage form
Eye drops, solution.
Main physicochemical properties: clear solution of dark red color.
Pharmacotherapeutic group
Ophthalmic drugs. ATX code S01X A.
Pharmacological properties
Pharmacodynamics
According to the quinoid theory of cataract pathogenesis, it is believed that the SH radical of a soluble protein contained in the lens of the eye degenerates and oxidizes under the action of a quinoid substance formed during the abnormal metabolism of aromatic amino acids such as tryptophan and tyrosine.
Azapentacene has a high affinity for the SH radical of soluble protein, inhibiting the action of quinoid substances on the protein contained in the lens of the eye. In addition, it was found that it is able to stimulate the action of a proteolytic enzyme present in the intraocular fluid of the anterior chamber of the eye.
Azapentacene is believed to have a preventive effect against cataract formation and may slow lens degeneration.
The use of azapentacene as eye drops slows the development of galactose cataracts (including nuclear cataracts) in rats.
Azapentacene did not cause acute toxicity in mice after a single oral dose of 5000 mg/kg.
The likelihood of eye irritation from azapentacene is low based on a study in which rabbits were topically administered azapentacene into the eye 5 times daily for 4 weeks.
Pharmacokinetics
Pharmacokinetic studies have not been conducted.
Indication
Cataract (age-related, traumatic, congenital, secondary).
Contraindication
Hypersensitivity reactions to the active substance or to other components of the drug.
Interaction with other medicinal products and other types of interactions
No clinically relevant interactions have been described.
Application features
If you are using multiple topical eye products at the same time, wait 10–15 minutes between applications. Eye ointments should be applied last.
The preparation contains thiomersal (an organomercury compound) as a preservative and may cause allergic reactions. The preparation also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate as preservatives, which may also cause allergic reactions (possibly delayed).
Ability to influence reaction speed when driving vehicles or other mechanisms
During the use of azapentacene, temporary blurred vision or other visual disturbances may occur, which may affect the ability to drive or use other mechanisms. If such reactions develop after instillation of the drug, the patient should wait until the vision clears before driving or using other mechanisms.
Use during pregnancy or breastfeeding
Pregnancy
There are limited data on the topical use of azapentacene in pregnant women. The drug is not recommended for use during pregnancy or in women of childbearing potential not using contraception.
Breastfeeding period
It is not known whether azapentacene is excreted in human milk after topical administration; however, a risk to the breast-fed infant cannot be excluded. A decision should be made whether to temporarily discontinue breast-feeding or to discontinue the drug, taking into account the potential benefit of azapentacene to the mother and the potential risk to the child.
Fertility
Studies on the effects of azapentacene when applied topically to the eye on reproductive function have not been conducted.
Method of administration and doses
The drug is intended for ophthalmic use only.
Instill 2 drops of the drug into the conjunctival sac of the affected eye(s) 3–5 times a day.
Nasolacrimal occlusion or tight eyelid closure is recommended after instillation. This reduces systemic absorption of agents administered into the eye, which reduces the likelihood of systemic side effects.
To prevent contamination of the dropper tip and solution, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the tip of the dropper bottle.
Children
The efficacy and safety of azapentacene in children have not been established. The drug is not recommended for use in this group of patients.
Overdose
In case of overdose with topical application, wash the excess drug from the eye with warm water.
Adverse reactions
The following adverse reactions have been identified during the use of azapentacene. The frequency of adverse reactions cannot be estimated from the available data.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions that occur after the marketing authorisation of a medicinal product is extremely important. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C in the original packaging and out of the reach of children. After opening the bottle, use the drug within 28 days.
Packaging
15 ml in a dropper bottle, 1 dropper bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
WORLD MEDICINE ILACH SAN. VE TIJ. A.Sh./ WORLD MEDICINE ILAC SAN. VE TIC. AS
Location of the manufacturer and its business address
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey/ 15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.
