Mitraseptin^®-OftalmoLOR (Drops) Instructions for Use

Marketing Authorization Holder

Lekko, CJS (Russia)

ATC Code

S03AA (Antimicrobial drugs)

Active Substance

Benzyldimethyl-myristoylamino-propylammonium (Grouping name)

Dosage Form

Mitraseptin®-OftalmoLOR

Eye, nasal, and ear drops 0.1 mg/1 ml: bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Eye, ear, nasal drops as a colorless, transparent solution.

Excipients: sodium chloride, purified water.

10 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.
15 ml – polymer bottles (1) with a dropper cap or dosing nozzle – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic

Pharmacotherapeutic Group

Agents for the treatment of eye and ear diseases; antimicrobial agents

Pharmacological Action

Antiseptic agent, has antiviral and bactericidal action (hydrophobic interaction with microorganism membranes leads to their destruction).

Active against gram-positive and gram-negative, aerobic and anaerobic, spore-forming and asporogenic bacteria in the form of monocultures and microbial associations, including hospital strains with polyresistance to antibiotics.

The highest sensitivity to this agent is exhibited by: gram-positive microorganisms (Staphylococcus spp., Streptococcus spp., Bacillus anthracoides, Bacillus subtilis); gram-negative microorganisms: Neisseria spp., Escherichia spp., Shigella spp. (including Sonne, Flexner), Salmonella spp. (typhoid fever, paratyphoid A and B, causative agents of food toxicoinfections), Vibrio spp. (including cholera, NAG, paracholera, parahaemolytic), Treponema pallidum, Corynebacterium diphtheriae; fungi (Candida albicans, Candida tropicalis, Trichophyton rubrum, Microsporum lanosum, Aspergillus niger); protozoa (Chlamydia trachomatis, Chlamydia pneumonia).

Characterized by high selectivity of action and practically does not affect human cells. Has anti-inflammatory action, enhances immune response, local protective reactions, regenerative processes.

Indications

Ophthalmology: complex treatment of infectious processes of the anterior segment of the eye (blepharitis, conjunctivitis, keratitis, keratouveitis); eye injuries; eye burns (thermal and chemical); in the pre-operative and post-operative periods for the treatment and prevention of purulent-inflammatory lesions of the eyes; prevention of ophthalmia neonatorum, including gonococcal and chlamydial; complex treatment of bacterial conjunctivitis in newborns.

Otorhinolaryngology: complex treatment of acute rhinitis; acute sinusitis/rhinosinusitis, exacerbation of chronic sinusitis/rhinosinusitis; acute and chronic external otitis, chronic purulent mesotympanitis, otomycosis.

ICD codes

Dosage Regimen

Administer the solution as directed by a physician. Dosing varies by indication, affected area, and patient age.

For ophthalmic use, instill drops into the conjunctival sac of the affected eye. Apply 1-2 drops per administration. Use 3-6 times daily or according to a specific regimen prescribed for the condition.

For otitis externa, instill 2-3 drops into the external auditory canal. Apply 4-6 times daily. Gently massage the tragus of the ear after instillation to facilitate distribution.

For acute rhinitis or sinusitis, administer 2-3 drops into each nasal passage. Use 4-6 times daily. Tilt the head back slightly during instillation.

The standard treatment course is 7-10 days. Do not exceed the recommended duration of use without medical supervision.

In the pre-operative and post-operative period for eye surgery, follow the specific prophylactic regimen provided by the surgeon.

For prevention of ophthalmia neonatorum, apply 1-2 drops into each conjunctival sac of the newborn once shortly after birth.

For complex treatment of bacterial conjunctivitis in newborns, apply 1 drop into each eye 3 times daily for 5-7 days.

Always remove contact lenses before ophthalmic application. Reinsert lenses no sooner than 15 minutes post-instillation.

If a dose is missed, apply it as soon as remembered. Do not double the next dose to compensate. Discontinue use and consult a physician if no improvement is seen within 3 days.

Adverse Reactions

Possible allergic reactions.

Local reactions burning sensation at the application site (resolves on its own within 10-15 sec).

Contraindications

Hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible only if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Contact lenses should be removed immediately before using this agent and reinserted no earlier than 15 minutes after instillation.

Drug Interactions

When used concomitantly, it increases the effectiveness of topical antibiotics.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.