Miristoil (Solution) Instructions for Use

Marketing Authorization Holder

Medicas, LLC (Russia)

Manufactured By

Flora Kavkaza, JSC (Russia)

ATC Code

D08AJ (Quaternary ammonium compounds)

Active Substance

Benzyldimethyl-myristoylamino-propylammonium (Grouping name)

Dosage Form

Miristoil

Solution for topical and external use 0.01 %: bottle 50 ml, 100 ml, 150 ml, 200 ml or 500 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for topical and external use colorless, transparent, foaming when shaken.

Excipients : purified water – up to 1 ml.

50 ml – polymer bottles (1) – cardboard packs.
100 ml – polymer bottles (1) – cardboard packs.
150 ml – polymer bottles (1) – cardboard packs.
200 ml – polymer bottles (1) – cardboard packs.
500 ml – polymer bottles (1) – cardboard packs.
50 ml – polymer bottles (1) with attachments* – cardboard packs.
100 ml – polymer bottles (1) with attachments* – cardboard packs.
150 ml – polymer bottles (1) with attachments* – cardboard packs.
200 ml – polymer bottles (1) with attachments* – cardboard packs.
500 ml – polymer bottles (1) with attachments* – cardboard packs.

* Attachments: sprayers or urological applicators or gynecological nozzles or push-button sprayers.

Clinical-Pharmacological Group

Topical antiseptic

Pharmacotherapeutic Group

Antiseptic

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 the drug is exhibited by: gram-positive microorganisms (Staphylococcus spp., Streptococcus spp., Bacillus anthracoides, Bacillus subtilis); gram-negative microorganisms: Neisseria spp., Escherichia spp., Shigella spp. (including S. sonnei, S. flexneri), Salmonella spp. (typhoid fever, paratyphoid A and B, causative agents of food toxicoinfections), Vibrio spp. (including V. cholerae, NAG, paracholera, parahaemolyticus), Treponema pallidum, Corynebacterium diphtheriae; fungi (Candida albicans, Candida tropicalis, Trichophyton rubrum, Microsporum lanosum, Aspergillus niger); protozoa (Chlamydia trachomatis, Chlamydia pneumonia).

Indications

Purulent wounds in surgical and obstetric practice; burns (superficial and deep); inflammatory diseases of female genital organs; sexually transmitted diseases (syphilis, gonorrhea, trichomoniasis, chlamydia, genital herpes); urethritis (acute and chronic), urethroprostatitis of specific (trichomoniasis, chlamydia, gonorrhea) and nonspecific nature; periodontitis, stomatitis, hygienic treatment of removable dentures; otitis (acute and chronic), sinusitis, tonsillitis, laryngitis; fungal lesions of the skin and mucous membranes.

ICD codes

Dosage Regimen

Topically and externally. For purulent wounds and burns – application of gauze dressings soaked in 0.01% solution.

For acute and chronic urethritis and urethroprostatitis the solution is injected into the urethra in a volume of 2-5 ml 2-3 times/day for 5-7 days (in combination with other drugs).

For prevention of postpartum trauma infection intravaginally insert tampons soaked in 50 ml of solution, with an exposure of 2 hours for 7 days.

For prevention of sexually transmitted diseases, before use, urinate, wash hands and genitals. Then unscrew the bottle cap, pressing on the walls, treat the skin of the pubis, inner surfaces of the thighs, genitals with a stream of solution. Insert the nozzle tip into the external opening of the urethra and squeeze out 1.5-3 ml (men) and 1-1.5 ml (women), into the vagina – 5-10 ml. Without releasing the fingers, remove the nozzle from the urethral opening, and hold the solution for 2-3 minutes.

After the procedure, it is not recommended to urinate for 2 hours. Preventively effective if the procedure is performed no later than 2 hours after sexual intercourse.

Adverse Reactions

Allergic reactions. Locally – burning sensation at the application site (resolves on its own within 10-15 seconds and does not require drug discontinuation).

Contraindications

Hypersensitivity.

Drug Interactions

With simultaneous use with antibiotics, a decrease in microorganism resistance to the latter has been noted.

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

Over-the-Counter

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.