Oftaklin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT OFTAKLIN

Composition:

Active ingredient: miramistin;

1 ml of solution contains miramistin 0.1 mg;

Excipients: sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.

Pharmaceutical form. Eye drops, solution.

Main physicochemical properties: colorless clear liquid.

Pharmacotherapeutic group.
Agents used in ophthalmology and otology. ATC code S03D.

Pharmacological Properties.

Pharmacodynamics.

Miramistin is a cationic surface-active substance with antimicrobial (antiseptic) activity.

The mechanism of action of miramistin is based on direct hydrophobic interaction of its molecules with lipids in microbial cell membranes, leading to their fragmentation and destruction. In this process, part of the miramistin molecule penetrates into the hydrophobic region of the membrane, disrupts the supramembrane layer, loosens the membrane structure, increases its permeability for high-molecular-weight substances, alters enzymatic activity of the microbial cell, and inhibits enzyme systems, resulting in suppression of microbial viability and cytolysis.

Unlike other antiseptics, miramistin demonstrates high selectivity towards microorganisms, as it has almost no effect on human cell membranes. This effect is attributed to the significantly longer lipid radicals, which sharply limit the possibility of hydrophobic interaction between miramistin and human cells.

Miramistin exhibits pronounced antimicrobial activity against Gram-positive (including Staphylococcus spp., Streptococcus spp.), Gram-negative, aerobic (including Chlamydia spp.), anaerobic, spore-forming and non-spore-forming bacteria, both as monocultures and microbial associations, including hospital strains with multidrug resistance to antibiotics. It also has antiviral activity against herpes viruses and adenoviruses.

It exerts antifungal effects against ascomycetes of the genera Aspergillus and Penicillium, yeasts (Rhodotorula rubra, Torulopsis gabrata), yeast-like fungi (Candida albicans, Candida krusei), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, T. schoenleini, T. violaceum, Epidermophyton Kaufman-Wolf, E. floccosum, Microsporum gypseum, Microsporum canis), as well as other pathogenic fungi such as Pityrosporum orbiculare (Malassezia furfur), both as monocultures and microbial associations, including fungal microflora resistant to chemotherapeutic agents. Under the influence of miramistin, microbial resistance to antibiotics decreases.

Miramistin exerts anti-inflammatory and immunoadjuvant effects, enhances local defense reactions and regenerative processes, and activates non-specific defense mechanisms through modulation of cellular and local humoral immune responses, thereby accelerating recovery.

Pharmacokinetics.

Miramistin exerts a local effect. There are no data available on the potential penetration of the drug into systemic circulation.

Clinical characteristics.

Indications.

Use in the complex treatment of infectious processes of the anterior segment of the eye (blepharitis, conjunctivitis, keratitis, keratouveitis), eye injuries, eye burns (thermal and chemical).

Prevention and treatment of purulent-inflammatory eye lesions in the pre- and postoperative periods.

For prevention of ophthalmia neonatorum, including gonococcal and chlamydial ophthalmia.

Contraindications.

Individual hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

When used concomitantly, Oftaklin enhances the efficacy of locally acting antibiotics.

If other medicinal products are used simultaneously, inform the physician.

Special precautions for use.

Contact lenses should be removed before using the medication. They may be reinserted no sooner than 15 minutes after instillation.

To avoid contamination of the dropper and solution, do not touch the eyelids, adjacent areas, or any other surfaces with the tip of the dropper bottle.

Using the dropper bottle and medication by more than one person may lead to the spread of infection.

Use during pregnancy or breastfeeding.

The use of this medication during pregnancy and breastfeeding should only be considered when the expected benefit to the mother outweighs the potential risk to the fetus.

Ability to affect reaction speed when driving or operating machinery.

Blurred vision may occur temporarily after application. Patients should wait until vision clears before driving or engaging in other activities that require heightened attention and quick reaction times.

Dosage and Administration.

The medicinal product Oftaklin is intended for ophthalmic use.

Adults

Instill 1–2 drops of the medicinal product into the conjunctival sac 4–6 times daily until clinical improvement occurs.

For prophylaxis, the medicinal product should be used 2–3 days before surgery and continued for 10–15 days after surgery, 1–2 drops 3 times daily.

In the treatment of eye burns, after rinsing the eye with large amounts of water, frequent instillations (every 5–10 minutes) should be performed for 1–2 hours. For subsequent treatment, Oftaklin is administered 1–2 drops 4–6 times daily.

Pediatric Use

For the treatment of bacterial conjunctivitis in children aged 3 years and older, Oftaklin is administered up to 6 times daily, 1 drop into the conjunctival sac, for 7–10 days.

For prophylaxis of ophthalmia neonatorum, instill 1 drop of the medicinal product into each eye of newborns twice, with a 2–3 minute interval between drops.

Children

The medicinal product may be used in pediatric practice.

Overdose.

Not observed.

Side effects.

Hypersensitivity reactions may occur during the use of the medicinal product. In some cases, a mild burning sensation and discomfort may occur, which resolve spontaneously within 15–20 seconds and do not require discontinuation of treatment.

If any adverse events occur, consult a physician.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is an important procedure. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals must report any suspected adverse reactions through the national pharmacovigilance system.

Shelf life. 2 years.

The medicinal product should not be used after the expiry date stated on the packaging or if the "first opening" control has been compromised.

After opening the vial, the medicinal product should not be used for more than 28 days.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. Keep the vial tightly closed between uses.

Packaging.

5 ml in a bottle with dropper and tamper-evident cap; 1 bottle in a carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13 Boryspylska Street, Kyiv, 02093, Ukraine.