Mirastenex (Solution) Instructions for Use

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

ATC Code

D08AJ (Quaternary ammonium compounds)

Active Substance

Benzyldimethyl-myristoylamino-propylammonium (Grouping Name)

Dosage Form

Mirastenex

Solution for topical and external use 0.01%

Dosage Form, Packaging, and Composition

Solution for topical and external use

100 ml – bottles – carton packs – Over-the-Counter
100 ml – bottles – carton packs /in a set with a urological applicator – 1 pc./ – Over-the-Counter
100 ml – bottles – carton packs /in a set with a urological applicator -1 pc., gynecological nozzle -1 pc./ – Over-the-Counter
100 ml – bottles – carton packs /in a set with a spray nozzle -1 pc./ – Over-the-Counter
100 ml – bottles (12 pcs.) – carton boxes – for hospitals
100 ml – bottles (12 pcs.) – carton cases – for hospitals
100 ml – bottles (30 pcs.) – carton boxes – for hospitals
100 ml – bottles (30 pcs.) – carton cases – for hospitals
100 ml – bottles (56 pcs.) – carton boxes – for hospitals
100 ml – bottles (56 pcs.) – carton cases – for hospitals
150 ml – bottles – carton packs /in a set with a spray nozzle -1 pc./ – Over-the-Counter
200 ml – bottles – carton packs /in a set with a spray nozzle -1 pc./ – Over-the-Counter
50 ml – bottles – carton packs – Over-the-Counter
50 ml – bottles – carton packs /in a set with a urological applicator – 1 pc./ – Over-the-Counter
50 ml – bottles – carton packs /in a set with a urological applicator – 1 pc.; spray nozzle – 1 pc./ – Over-the-Counter
50 ml – bottles – carton packs /in a set with a urological applicator -1 pc., gynecological nozzle -1 pc./ – Over-the-Counter
50 ml – bottles (12 pcs.) – carton boxes – for hospitals
50 ml – bottles (12 pcs.) – carton cases – for hospitals
50 ml – bottles (30 pcs.) – carton boxes – for hospitals
50 ml – bottles (30 pcs.) – carton cases – for hospitals
50 ml – bottles (56 pcs.) – carton boxes – for hospitals
50 ml – bottles (56 pcs.) – carton cases – for hospitals
500 ml – bottles – carton packs – Over-the-Counter
500 ml – bottles (12 pcs.) – carton boxes – for hospitals
500 ml – bottles (12 pcs.) – carton cases – for hospitals
500 ml – bottles (30 pcs.) – carton boxes – for hospitals
500 ml – bottles (30 pcs.) – carton cases – for hospitals
500 ml – bottles (56 pcs.) – carton boxes – for hospitals
500 ml – bottles (56 pcs.) – carton cases – for hospitals

Clinical-Pharmacological Group

Topical antiseptic

Pharmacotherapeutic Group

Antiseptics and disinfectants; quaternary ammonium compounds

Pharmacological Action

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

It is 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 following microorganisms exhibit the highest sensitivity to the drug: 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).

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 introduced 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, tampons soaked in 50 ml of solution are introduced intravaginally, with an exposure of 2 hours for 7 days.

For prevention of sexually transmitted diseases, before use, one should 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 tip of the nozzle 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. It is prophylactically effective if the procedure is performed no later than 2 hours after sexual intercourse.

Adverse Reactions

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

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.