Okomistin^® (Drops) Instructions for Use

Marketing Authorization Holder

Infamed, LLC (Russia)

Manufactured By

Infamed K, LLC (Russia)

Contact Information

INFAMED, LLC (Russia)

ATC Code

S03AA (Antimicrobial drugs)

Active Substance

Benzyldimethyl-myristoylamino-propylammonium (Grouping name)

Dosage Form

Okomistin®

Eye, ear, nasal drops 0.01%: tube-droppers 1 ml, 1.5 ml 5 or 10 pcs., polymer bottles 5 ml, 10 ml 1 or 5 pcs., glass bottles 20 ml 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Eye, ear, nasal drops as a colorless, transparent liquid that foams when shaken.

Excipients: sodium chloride – 0.9 g, purified water – up to 100 ml.

1 ml or 1.5 ml in single-use polymer tube-droppers; 5 ml or 10 ml in polymer bottles, sealed with a dropper cap and a screw cap with first-opening control.

5 or 10 tube-droppers of 1 ml or 1.5 ml, 1 bottle of 5 ml or 10 ml with the instructions for medical use in a cardboard carton.

Clinical-Pharmacological Group

Topical antiseptic

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

The main active substance of the drug Okomistin^® is the antiseptic Benzyldimethyl-myristoylamino-propylammonium, which has a pronounced antimicrobial effect against gram-positive and gram-negative, aerobic and anaerobic bacteria in the form of monocultures and microbial associations, including hospital strains with polyresistance to antibiotics. The drug acts on chlamydia, pathogenic fungi, as well as on herpes viruses and adenoviruses. The drug is more effective against gram-positive bacteria, including staphylococci and streptococci. It has an antifungal effect on ascomycetes of the genus Aspergillus and the genus Penicillium, yeasts (Rhodotorula rubra, Torulopsis glabrata) and yeast-like fungi (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton schoenleini, Trichophyton violaceum, Epidermophyton Kaufmann-Wolf, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis), as well as on other pathogenic fungi (for example, Pityrosporum orbiculare (Malassezia furfur)) in the form of monocultures and microbial associations, including fungal microflora with resistance to chemotherapeutic drugs.

The action of benzyldimethyl-myristoylamino-propylammonium is based on the direct hydrophobic interaction of the molecule with the lipids of microorganism membranes, leading to their fragmentation and destruction. In this case, part of the benzyldimethyl-myristoylamino-propylammonium molecule, immersing into the hydrophobic region of the membrane, destroys the supramembrane layer, loosens the membrane, increases its permeability to high-molecular-weight substances, changes the enzymatic activity of the microbial cell, and inhibits enzyme systems, which leads to the suppression of microorganism viability and their cytolysis.

Benzyldimethyl-myristoylamino-propylammonium has high selectivity of action against microorganisms, as it practically does not act on human cell membranes, which is associated with the different structure of the latter – a significantly greater length of lipid radicals, sharply limiting the possibility of hydrophobic interaction of benzyldimethyl-myristoylamino-propylammonium with cells.

Under the action of the drug, the resistance of bacteria and fungi to antibiotics decreases. Benzyldimethyl-myristoylamino-propylammonium has anti-inflammatory and immuno-adjuvant action, enhances local defense reactions, regenerative processes, and activates mechanisms of non-specific protection due to the modulation of cellular and local humoral immune response.

Pharmacokinetics

The drug has a local action. Data on possible penetration into the bloodstream are absent.

Indications

Ophthalmology

• In the complex treatment of infectious processes of the anterior part 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.

Otorhinolaryngology

• In the complex treatment of acute sinusitis/rhinosinusitis, exacerbation of chronic sinusitis/rhinosinusitis, acute rhinitis;
• In the complex treatment of acute and chronic external otitis, chronic purulent mesotympanitis, otomycosis.

ICD codes

Dosage Regimen

The drug is applied topically.

Ophthalmology

For therapeutic purposes in adults, Okomistin^® is instilled into the conjunctival sac, 1-2 drops 4-6 times/day until clinical recovery.

For prophylactic purposes, the drug is instilled 2-3 days before surgery, and also for 10-15 days after surgery, 1-2 drops 3 times/day.

In the treatment of eye burns, after washing the eye with plenty of water, frequent instillations (every 5-10 minutes) are performed for 1-2 hours. For further treatment, the drug is used 1-2 drops 4-6 times/day.

For the treatment of bacterial conjunctivitis in children, Okomistin^® is instilled into the conjunctival sac, 1 drop up to 6 times/day for 7-10 days.

For the prevention of ophthalmia in newborns, immediately after birth, 1 drop of the drug is instilled into each eye twice with an interval of 2-3 minutes.

Otorhinolaryngology

For acute sinusitis/rhinosinusitis, exacerbation of chronic sinusitis/rhinosinusitis, acute rhinitis, infection of the nasal mucosa in adults, Okomistin^® is instilled 2-3 drops into each nostril 4-6 times/day. The course of treatment is up to 14 days.

For the treatment of acute rhinosinusitis, exacerbation of chronic rhinosinusitis in children over 1 year, Okomistin^® is instilled into each nasal passage, 1-2 drops up to 4-6 times/day for 10-14 days.

For acute and chronic external otitis, otomycosis in adults, Okomistin^® is instilled into the external auditory canal, 5 drops 4 times/day, or instead of instillation, a gauze wick soaked in the drug is inserted into the external auditory canal 4 times/day. The course of treatment is 10 days.

For chronic mesotympanitis, the drug is used in adults in complex treatment using hardware ultrasonic irrigation or introduction into the tympanic cavity together with antibiotics.

In the absence of positive dynamics (increase in severity or appearance of new signs/symptoms of the disease, occurrence of complications) on the 3rd-4th day of therapy using Okomistin^®, the patient should consult a doctor!

Adverse Reactions

Allergic reactions are possible.

In some cases, a slight burning sensation and discomfort may occur, which disappear on their own after 15-20 seconds and do not require discontinuation of the drug.

If any adverse events occur, the patient should consult a doctor.

Contraindications

• Individual hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug 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 can be used in pediatric practice.

Geriatric Use

There are no specific restrictions for use in elderly patients.

Special Precautions

Contact lenses should be removed immediately before instillation of Okomistin^® and reinserted no earlier than 15 minutes after instillation.

To avoid contamination and cross-infection, one bottle should not be used for simultaneous treatment of eye, nose, and/or ear infections. To prevent contamination of the solution during instillation, patients should avoid contact of the dropper tip with the eye and skin. Use of the dropper bottle by more than one person may lead to the spread of infection.

Use in pediatrics

The drug can be used in pediatric practice.

Effect on ability to drive vehicles and operate machinery

After using the drug, a temporary decrease in the clarity of visual perception is possible, therefore, until it is restored, it is not recommended to drive a car and engage in activities requiring increased attention and quick reactions.

Overdose

Not observed.

Drug Interactions

When used concomitantly, Okomistin^® increases the effectiveness of topical antibiotics.

Studies of the drug’s interaction with other medicinal products have not been conducted.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

The shelf life after opening the bottle is 1 month.

Dispensing Status

The drug is dispensed by prescription.

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.