Cataxol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KATAKSOLOL (CATAXOL)

Composition:

Active substance: sodium azapentacen polysulfonate;

1 ml of solution contains sodium azapentacen polysulfonate 0.15 mg;

Excipients: disodium tetraborate decahydrate, boric acid, potassium chloride, thiomersal, methylparaben (E 218), propylparaben (E 216), sodium hydroxide solution, water for injections.

Pharmaceutical form. Eye drops, solution.

Main physicochemical properties: transparent dark red solution.

Pharmacotherapeutic group.

Ophthalmological agents. ATC code S01X A.

Pharmacological Properties

Pharmacodynamics

According to the quinone theory of cataract pathogenesis, the SH-group of soluble protein present in the eye lens degenerates and oxidizes under the influence of quinoid substances formed during the abnormal metabolism of aromatic amino acids such as tryptophan and tyrosine.

Azapentacene has a high affinity for the SH-group of soluble protein, inhibiting the action of quinoid substances on the protein present in the eye lens. In addition, it has been found to stimulate the activity of a proteolytic enzyme present in the aqueous humor of the anterior chamber of the eye.

Azapentacene is considered to have a prophylactic effect against cataract formation and may slow lens degeneration.

The use of azapentacene as eye drops has been shown to delay the development of galactose-induced cataract (including nuclear cataract) in rats.

Azapentacene did not cause acute toxicity in mice after a single oral dose of 5000 mg/kg.

The likelihood of ocular irritation following the use of azapentacene is low, based on a study in which rabbits received azapentacene administered locally into the eye five times daily for four weeks.

Pharmacokinetics

Pharmacokinetic studies have not been conducted.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity reactions to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interactions.

No clinically relevant interactions have been reported.

Special precautions for use

If several topical ophthalmic agents are used simultaneously, a 10–15 minute interval should be observed between their applications. Ophthalmic ointments should be applied last.

The medicinal product contains thiomersal (an organomercury compound) as a preservative and may cause allergic reactions. The product also contains methylparahydroxybenzoate and propylparahydroxybenzoate as preservatives, which may also cause allergic reactions (possibly delayed-type).

Use during pregnancy or breastfeeding

Pregnancy

Data on the topical ophthalmic use of azapentacene in pregnant women are limited. The medicinal product is not recommended during pregnancy, or in women of childbearing potential who are not using contraceptive measures.

Breastfeeding

It is unknown whether azapentacene passes into human breast milk following topical ophthalmic administration; however, a risk to the nursing infant cannot be excluded. A decision should be made whether to discontinue breastfeeding or to discontinue the use of the medicinal product, taking into account the benefit of treatment with azapentacene for the mother and the potential risk to the infant.

Fertility

No studies on the effect of topically administered azapentacene on reproductive function have been conducted.

Ability to affect reaction speed when driving or operating machinery

Transient blurred vision or other visual disturbances may occur after administration of azapentacene, which may affect the ability to drive or operate machinery. If such reactions occur, patients should wait until vision clears before driving or operating machinery.

Dosage and Administration.

The medicinal product is intended for ophthalmic use only.

Instill 2 drops of the medicinal product into the conjunctival sac of the affected eye(s) 3–5 times daily.

After instillation, nasolacrimal occlusion or firm eyelid closure is recommended. This reduces systemic absorption of agents administered into the eye, thereby decreasing the likelihood of systemic adverse 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 azapentacen in children have not been established. The medicinal product is not recommended for use in this patient group.

Overdose.

In case of overdose with topical administration, flush the excess medicinal product from the eye with warm water.

Side effects

The following side effects have been identified during the use of azapentacene. The frequency of occurrence of these side effects cannot be determined from the available data.

Eye disorders: eye pain, eye irritation, increased lacrimation, eye hyperemia.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after a medicinal product is authorized is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 ºC in the original packaging and in a place inaccessible to children. After opening the bottle, the product should be used within 28 days.

Packaging.

15 ml in a dropper bottle, 1 dropper bottle in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

UORLД MEDICINE ILAC SAN. VE TIC. A.S.
WORLD MEDICINE ILAC SAN. VE TIC. A.S.

Manufacturer's address and place of business.

15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.

Marketing Authorization Holder.

WORLD MEDICINE LLC, Ukraine.