Oftamirin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT OFTAMIRIN (OFTAMIRIN)

Composition:

Active substance: 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/ear/nasal drops.

Main physico-chemical properties: colorless transparent liquid.

Pharmacotherapeutic group. Agents used in ophthalmology and otology. Anti-edematous and other agents for local use in nasal cavity disorders. ATC code: S03D, R01A.

Pharmacological Properties

Pharmacodynamics

Miramistin is a cationic surface-active agent 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. Part of the miramistin molecule penetrates into the hydrophobic region of the membrane, disrupting the supramembrane layer, loosening the membrane structure, increasing its permeability for high-molecular-weight substances, altering the enzymatic activity of the microbial cell, and inhibiting enzyme systems. This leads to suppression of microbial viability and their subsequent cytolysis.

Unlike other antiseptics, miramistin demonstrates high selectivity towards microorganisms, as it has virtually no effect on human cell membranes. This effect is attributed to the different structure of human cell membranes (which have significantly longer lipid radicals that greatly limit the possibility of hydrophobic interaction with miramistin).

Miramistin exerts pronounced antimicrobial activity against Gram-positive and Gram-negative, aerobic and anaerobic, spore-forming and non-spore-forming bacteria, both as monocultures and microbial associations, including hospital strains with multidrug resistance to antibiotics.

It has a destructive effect on pathogens of sexually transmitted infections—gonococci, Treponema pallidum, trichomonads, chlamydia—as well as on herpes viruses, human immunodeficiency virus, etc. It also exhibits antifungal activity against ascomycetes of the genus Aspergillus and the genus Penicillium, yeasts (Rhodotorula rubra, Torulopsis gabrata, etc.), yeast-like fungi (Candida albicans, Candida krusei, etc.), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, T. schoenleini, T. violaceum, Epidermophyton Kaufman-Wolf, E. floccosum, Microsporum gypseum, Microsporum canis, etc.), and other pathogenic fungi (e.g., Pityrosporum orbiculare (Malassezia furfur)) 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 mechanisms of non-specific protection by modulating cellular and local humoral immune responses, thereby accelerating recovery.

Pharmacokinetics

Miramistin exerts a local effect. Data on the potential penetration of the drug into the systemic circulation are not available.

Clinical characteristics.

Indications.

In complex treatment of infectious processes of the anterior segment of the eye (blepharitis, conjunctivitis, keratitis, keratouveitis) caused by gram-positive and gram-negative bacteria, chlamydia, fungi, and viruses sensitive to miramistin, as well as eye injuries and eye burns (thermal and chemical).

Prevention of ophthalmia neonatorum, including gonococcal and chlamydial. Prevention and treatment of purulent-inflammatory eye disorders in pre- and postoperative periods.

In complex treatment of acute and chronic external otitis, chronic suppurative mesotympanitis, and otomycoses.

In complex treatment of acute rhinitis.

Contraindications.

Hypersensitivity to miramistin or to any other components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

When used concomitantly, Oftamirin enhances the efficacy of locally acting antibiotics. When using any other medicinal products simultaneously, inform your physician.

Instructions for use.

Use during pregnancy or breastfeeding.

The medicinal product may be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery.

The medicinal product does not affect reaction speed when driving vehicles or operating machinery.

Method of Administration and Dosage.

Ophthalmology.

For treatment of infectious processes of the anterior segment of the eye: in adults and children aged 12 years and older, instill 2–3 drops into the conjunctival sac 4–6 times daily; in children under 12 years of age – 1–2 drops 4–6 times daily. Treatment duration usually does not exceed 2 weeks.

For prevention of complications in pre- and postoperative periods: 2–3 drops 3 times daily for 2–3 days before surgery. After surgery – 1–2 drops 3 times daily for 3–5 days.

For treatment of eye burns: after rinsing the eye with large amounts of water, administer frequent instillations (every 5–10 minutes) for 1–2 hours. For further treatment, use the medication in adults and children aged 12 years and older – 2–3 drops, in children under 12 years of age – 1–2 drops 4–6 times daily.

For prevention of ophthalmia in newborns: immediately after birth, instill 1 drop of the medication into each eye 3 times with an interval of 2–3 minutes.

Otolaryngology.

For treatment of acute and chronic external otitis, otomycoses:

in adults and children aged 12 years and older – 3–5 drops 4–6 times daily;

in children under 12 years of age – 2–3 drops 4–6 times daily.

A gauze wick moistened with the medication may be inserted into the external auditory canal 4–6 times daily for 10–14 days (as an alternative to instillation).

For chronic mesotympanitis: use as part of combination therapy via instrumental ultrasonic irrigation or administration into the tympanic cavity together with antibiotics.

For treatment of acute rhinitis, mucosal infections of the nose: instill 2–3 drops in adults and children aged 12 years and older, and 1–2 drops in children under 12 years of age into each nostril 4–6 times daily. Treatment course – 7–14 days.

Dosage specifics. Accurate dosing is achieved by pressing the bottom of the bottle – 1 press = 1 drop.

Children.

The medicinal product can be used in pediatric practice.

Overdose.

Cases of overdose have not been reported.

Side effects.

Hypersensitivity reactions may occur during use of the medicinal product. In some cases, a transient burning sensation may occur, which resolves spontaneously within 5–20 seconds and does not require discontinuation of treatment.

Shelf life. 3 years.

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

After opening the bottle, the medicinal product must not be used for more than 28 days.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 30 °C.

Keep the bottle tightly closed between uses.

Packaging.

5 ml of the product in a bottle; 1 bottle per box.

Prescription status. Prescription only.

Manufacturer. JSC "Pharmaceutical Company "Darnitsya".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.