Instructions for use Oftamirin eye/ear/nasal drops 0.1 mg/ml bottle 5 ml
Composition
active ingredient: miramistin;
1 ml of solution contains 0.1 mg of miramistin;
Excipients: sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.
Dosage form
Eye/ear/nasal drops.
Main physicochemical properties: colorless transparent liquid.
Pharmacotherapeutic group
Means used in ophthalmology and otology. Anti-edematous and other drugs for local use in diseases of the nasal cavity. ATX code S03D, R01A.
Pharmacological properties
Pharmacodynamics.
Miramistin is a cationic surfactant with antimicrobial (antiseptic) action.
The action of Miramistin is based on the direct hydrophobic interaction of the molecule with the lipids of the membranes of microorganisms, which leads to their fragmentation and destruction. At the same time, part of the Miramistin molecule, immersing in the hydrophobic area of the membrane, destroys the supramembrane layer, loosens the membrane, increases its permeability for high-molecular substances, changes the enzymatic activity of the microbial cell, inhibits enzyme systems, which causes inhibition of the vital activity of microorganisms and their cytolysis.
Unlike other antiseptics, Miramistin has a high selectivity of action against microorganisms, since it practically does not act on the membranes of human cells. This effect is associated with a different structure of human cell membranes (a significantly longer length of lipid radicals, which sharply limits the possibility of hydrophobic interaction of Miramistin with cells).
Miramistin has a pronounced antimicrobial effect 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 multi-resistance to antibiotics.
It has a detrimental effect on pathogens of sexually transmitted diseases - gonococci, pale treponema, trichomonads, chlamydia, as well as herpes viruses, human immunodeficiency virus, etc. It has an antifungal effect on ascomycetes of the genus Aspergillus and the genus Penicillum, yeast (Rhodotorula rubra, Torulopsis gabrata, etc.) and yeast-like (Candida albicans, Candida krusei, etc.) fungi, dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichopphyton verrucosum, T. schoenleini, T. violaceum, Epidermophyton Kaufman-Wolf, E. floccosum, Microsporum gypseum, Microsporum canis, etc.), 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. Under the action of Miramistin, the resistance of microorganisms to antibiotics decreases.
Miramistin has an anti-inflammatory and immunoadjuvant effect, enhances local protective reactions, regenerative processes, activates nonspecific defense mechanisms due to modulation of cellular and local humoral immune responses, thereby accelerating recovery.
Pharmacokinetics.
Miramistin has a local effect. There is no data on the possibility of the drug penetrating the systemic bloodstream.
Indication
In the 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, eye injuries, eye burns (thermal and chemical).
Prevention of ophthalmia of newborns, including gonococcal and chlamydial. Prevention and treatment of purulent-inflammatory eye lesions in the pre- and postoperative period.
In the complex treatment of acute and chronic otitis externa, chronic purulent mesotympanitis, otomycosis.
In the complex treatment of acute rhinitis.
Contraindication
Increased individual sensitivity to Miramistin or other components of the drug.
Interaction with other medicinal products and other types of interactions
When used together, Oftamirin increases the effectiveness of topical antibiotics. If you are using any other medications at the same time, you should inform your doctor.
Use during pregnancy or breastfeeding
The medicine can be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the speed of reactions when driving vehicles and other mechanisms.
Method of administration and doses
Ophthalmology.
For the treatment of infectious processes of the anterior segment of the eye, adults and children over 12 years of age should instill 2-3 drops into the conjunctival sac, and children under 12 years of age should instill 1-2 drops 4-6 times a day. The duration of treatment usually does not exceed 2 weeks.
To prevent complications in the pre- and postoperative period - 2-3 drops 3 times a day for 2-3 days before the operation. After the operation - 1-2 drops 3 times a day for 3-5 days.
To prevent ophthalmia in newborns, immediately after birth, instill 1 drop of the drug into each eye 3 times with an interval of 2-3 minutes.
Otolaryngology.
In the treatment of acute and chronic external otitis, otomycosis
adults and children over 12 years of age should instill 3-5 drops 4-6 times a day;
children under 12 years old – 2-3 drops 4-6 times a day.
A gauze swab moistened with the medicine can be inserted into the external auditory canal 4-6 times a day for 10-14 days (instead of instillation).
In chronic mesotympanitis, use in complex treatment using hardware ultrasonic irrigation or injection into the tympanic cavity together with antibiotics.
In the treatment of acute rhinitis, infections of the nasal mucosa, instill 2-3 drops in adults and children over 12 years of age, 1-2 drops in each nasal passage 4-6 times a day in children under 12 years of age. The course of treatment is 7-14 days.
Dosage features. Accurate dosing is achieved by pressing the bottom of the bottle – 1 press = 1 drop.
Children.
The drug can be used in pediatric practice.
Overdose
No cases of overdose have been observed.
Side effects
Hypersensitivity reactions are possible when using the drug. In some cases, a short-term burning sensation is possible, which disappears on its own after 5-20 seconds and does not require discontinuation of treatment.
Expiration date
3 years.
The medicine cannot be used after the expiry date indicated on the packaging and in cases where the “first opening” control has been violated.
After opening the bottle, the medicine should be used for no more than 28 days.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 30 °C.
Keep the bottle tightly closed between uses.
Packaging
5 ml of the drug in a bottle; 1 bottle in a pack.
Leave category. By prescription.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
