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Composition:


active ingredient: sodium azapentacene polysulfonate;


1 ml of the solution contains sodium azapentacene polysulfonate 0.15 mg;


excipients: disodium tetraborate decahydrate, boric acid, potassium chloride, thiomersal, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium hydroxide solution, water for injection.


Dosage form. Eye drops, solution.


Basic physical and chemical properties: clear solution of dark red color.


Pharmacotherapeutic group.


Ophthalmic products. ATX code S01X A.


Pharmacological properties.


Pharmacodynamics.


According to the quinoid theory of cataract pathogenesis, it is believed that SN, a soluble protein radical contained in the lens of the eye, degenerates and oxidizes under the action of a quinoid substance formed during abnormal metabolism of aromatic amino acids such as tryptophan and tyrosine.


Azapentacen has a high affinity for the SN radical of soluble protein, inhibiting the effect of the quinoid substance on the protein contained in the lens of the eye. In addition, it was found to be able to stimulate the action of a proteolytic enzyme present in the intraocular fluid of the anterior chamber of the eye.


Azapentacen is thought to have a preventive effect against cataract formation and may slow lens degeneration.


The use of azapentacen as eye drops slows down 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 when using azapentacen is low according to a study in which rabbits were locally injected with azapentacen 5 times a day for 4 weeks.


Pharmacokinetics.


No pharmacokinetic studies have been conducted.


Clinical characteristics.


Indications.


Cataracts (age-related, traumatic, congenital, secondary).


Contraindications.


Hypersensitivity reactions to the active substance or other components of the drug.


Interactions with other drugs and other types of interactions.


No clinically relevant interactions have been described.


Application features.


If you apply several topical products to the eyes at the same time, you should wait 10-15 minutes between their application. Eye ointments should be applied last.


The drug contains thiomersal (an organomercury compound) as a preservative and may cause allergic reactions. The drug also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate as preservatives, which can also lead to allergic reactions (possibly delayed type).


Use during pregnancy or lactation.


Pregnancy


Data on topical use of azapentacene in pregnant women are limited. The drug is not recommended for use during pregnancy, as well as for women of reproductive age who do not use contraceptives.


Breast-feeding period


It is not known whether azapentacen penetrates into breast milk after topical application; however, the risk to an infant who is breastfed cannot be excluded. Consideration should be given to temporarily discontinuing breast-feeding or discontinuing the drug, given the potential benefits of azapentacen for the mother and the risk to the child.


Fertility


Studies of the effect of azapentacene when applied topically to the eye on reproductive function have not been carried out.


Ability to influence the reaction rate 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 vehicles or other mechanisms. If such reactions develop after instillation of the drug, the patient should wait until vision clears before driving vehicles or other mechanisms.


Dosage and administration.


The drug is intended for ophthalmic use only.


Instill 2 drops of the drug in the conjunctival sac of the affected eye (s) 3-5 times a day.


After instillation, nasolacrimal occlusion or tight closing of the eyelid is recommended. This reduces the systemic absorption of drugs injected into the eye, which reduces the likelihood of systemic side effects.


To prevent contamination of the edge of the dropper and solution, Be careful not to touch the eyelids, adjacent areas or other surfaces with the edge of the dropper bottle.


Children.


The efficacy and safety of azapentacen 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 out of the eye with warm water.


Adverse reactions.


The following adverse reactions were detected during the use of azapentacene. The frequency of adverse reactions cannot be estimated from the available data.


From the side of the visual organs: eye pain, eye irritation, increased lacrimation, hyperemia of the eyes.


Reports of suspected adverse reactions


Reports of suspected adverse reactions that occur after drug registration are extremely important. This allows you to constantly monitor the benefit/risk balance of the drug. Health care workers are asked to report any suspected adverse reactions through the National notification system.


Expiration date.


3 years old.


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 for 28 days.

Tags: Cataxol® [Sodium azapentacene]