Instructions Miramistin solution 0.01% bottle 50 ml
Composition
active ingredient: myramistin;
1 ml of solution contains 0.1 mg of miramistin;
excipient: purified water.
Dosage form
Solution for external use.
Main physicochemical properties: colorless or with a yellowish tinge, transparent liquid that foams when shaken.
Pharmacotherapeutic group
Antiseptics and disinfectants. ATX code D08A J.
Pharmacological properties
Pharmacodynamics
Miramistin has a pronounced bactericidal effect on gram-positive and gram-negative, aerobic and anaerobic bacteria in the form of monocultures and microbial associations, including hospital strains resistant to antibiotics. The drug is effective against gram-positive bacteria (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae, etc.) and gram-negative bacteria (Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp., etc.), acts on pathogens of sexually transmitted diseases (Chlamydia spp., Treponema spp, Trichomonas vaginalis, Neisseria gonorrhoeae), as well as herpes viruses, human immunodeficiency viruses, etc. It has an antifungal effect on ascomycetes of the genus Aspergillus and the genus Penicillium, yeasts (Rhodotorula rubra, Torulopsis gabrata, etc.) and yeast-like fungi (Candida albicans, Candida tropicalis, Candida krusei, etc.), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton schoenleini, Trichophyton violacent, Epidermophyton Kaufinan-Wolf, Epidermophyton 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. Effectively prevents infection of wounds and burns, activates regeneration processes. Stimulates protective reactions at the site of application, due to the activation of the absorbing and digesting function of phagocytes, potentiates the activity of the monocyte-macrophage system. Has a pronounced hyperosmolar activity, as a result of which it stops wound and perifocal inflammation, absorbs purulent exudate, contributing to the formation of a dry scab. Does not damage granulations and viable skin cells, does not inhibit marginal epithelialization.
It has no allergenic properties and does not have a local irritating effect.
Pharmacokinetics
When applied topically, it is not absorbed through the skin and mucous membranes.
Indication
Surgery, traumatology: local treatment of infected wounds of various localization and etiology; prevention of secondary infection of granulating wounds.
Combustiology: treatment of II and III A degree burns; preparation of burn wounds for dermatoplastic surgery.
Obstetrics and gynecology: prevention and treatment of suppuration of postpartum wounds, postpartum infections, perineal and vaginal wounds; inflammatory diseases of the external genitalia and vagina (vulvovaginitis).
Dermatology: complex treatment of candidiasis of the skin and mucous membranes, mycosis of the feet and large folds.
Venereology: individual prevention of sexually transmitted diseases (syphilis, gonorrhea, genital herpes).
Otorhinolaryngology: comprehensive treatment of acute and chronic otitis media, sinusitis, tonsillitis.
Dentistry: treatment of periodontitis, stomatitis; hygienic treatment of removable dentures; prevention of microbial complications after surgical interventions on the oral mucosa.
Contraindication
Individual sensitivity to Miramistin.
Interaction with other medicinal products and other types of interactions
When used simultaneously with antibiotics, an increase in their antibacterial and antifungal properties has been noted.
Application features
Venereology. After treating the urethra, vagina, inner thighs, pubis, and external genitalia with Miramistin®, urination is not recommended for 2 hours.
Use during pregnancy or breastfeeding
Since the drug is almost completely absorbed, Miramistin® can be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Miramistin® does not affect the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
The solution is ready for use. Apply topically to adults.
Surgery, traumatology, combustiology. For prophylactic and therapeutic purposes, irrigate the surface of wounds and burns with Miramistin®, loosely pack the wound and fistula passages, fix gauze tampons moistened with an antiseptic. Repeat the treatment procedure 2–3 times a day for 3–5 days. The method of active drainage of wounds and cavities with a daily consumption of up to 1 liter of the drug is effective.
When women give birth by cesarean section, the vagina is treated immediately before the operation, during the operation - the uterine cavity and the incision on it, and in the postoperative period, tampons moistened with the drug are inserted into the vagina with an exposure of 2 hours for 7 days. Treatment of inflammatory diseases of the female genital organs is carried out in a course for 2 weeks, by intravaginal administration of tampons with the drug, treatment of the skin of the external genital organs, as well as using electrophoresis.
Dermatology. Treatment of candidiasis of the skin and mucous membranes, mycoses of the feet and large folds should be carried out by applications 2–4 times a day.
Venereology. For individual prevention of sexually transmitted diseases, Miramistin solution is effective if used no later than 2 hours after sexual intercourse. The contents of the bottle should be injected into the urethra using a urethral nozzle - 2–3 ml (for men), 1–2 ml (for women), into the vagina - 5–10 ml for 2–3 minutes. After the procedure, it is not recommended to empty the bladder for 2 hours. Treat the skin of the inner surface of the thighs, pubis, and external genitalia.
Otorhinolaryngology. In case of purulent sinusitis, during puncture, rinse the maxillary sinus with a sufficient amount of the drug. In the treatment of tonsillitis, pharyngitis and laryngitis, gargle with Miramistin® solution 3–4 times a day. The amount of the drug per rinse is 10–15 ml. In case of otitis, insert a tampon moistened with the drug into the external auditory canal 4–6 times a day for 10–14 days.
Dentistry. In the treatment of periodontitis, Miramistin solution is injected into periodontal pockets on turundas with subsequent applications to the gums for 15 minutes. In case of exacerbations, wash the periodontal pockets with Miramistin® using a syringe and insert turundas with the drug into the abscess cavity. After vestibuloplasty and frenulectomy, the drug is used in the form of baths in outpatient conditions. In case of stomatitis, gingivitis, it is recommended to rinse the oral cavity with 10–15 ml of the drug 3–4 times a day. For the purpose of hygienic treatment of removable dentures, leave them overnight in Miramistin solution, and before using the dentures, thoroughly rinse them with running water.
Children
Since there is not sufficient experience with the use of Miramistin solution for the treatment of children, it should not be used in pediatric practice.
Overdose
Overdose phenomena were not observed.
Adverse reactions
In some cases, a short-term burning sensation may occur, which disappears on its own after 15–20 seconds and does not require discontinuation of the drug.
Hypersensitivity reactions, including local skin irritation: itching, hyperemia, burning sensation, dry skin.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. It allows for continued monitoring of the benefit-risk balance of the medicinal product in question. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Do not freeze. Keep out of reach of children.
Packaging
50 ml in a bottle, 1 bottle with a urethral nozzle in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business
Ukraine, 02093, Kyiv, Boryspilska St., 13.
