Each capsule contains:
- Neomycin sulfate 35,000 IU
- Polymyxin B sulfate 35,000 IU
- Nystatin 100,000 IU
Inactive ingredients: Tefoz 63®, hydrogenated soybean oil, dimethicone 1000
Capsule shell composition: gelatin, glycerol, dimethicone 1000
It evenly distributes across the vaginal mucosa, providing local bactericidal and fungicidal effects. It is virtually not absorbed from the vaginal mucosal surface.
This is a combination medication with its effects stemming from its components. It has antibacterial, bactericidal, and antifungal actions.
Neomycin Sulfate is an aminoglycoside antibiotic that exerts bactericidal action by blocking the ribosomal function of a wide range of gram-positive (Corynebacterium, Listeria monocytogenes, Staphylococcus meti-S) and gram-negative microorganisms: Acinetobacter (primarily Acinetobacter baumanii), Branhamella catarrhalis, Campylobacter, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenza, Klebsiella, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Salmonella, Serratia, Shigella, Yersinia.
Polymyxin B Sulfate is a peptide antibiotic that acts bactericidally against predominantly gram-negative flora, especially Pseudomonas aeruginosa; sensitive strains also include Acinetobacter, Aeromonas, Alcaligenes, Citrobacter freundii, Citrobacter Koseri, Enterobacter, Escherichia coli, Klebsiella, Moraxella, Salmonella, Shigella, Stenotrophomonas maltophilia. Polymyxin B disrupts the osmotic resistance of bacterial membranes and is also active against microorganisms in the resting state.
Streptococcus spp. and anaerobic bacteria are not sensitive to neomycin and polymyxin B.
Nystatin is a polyene antibiotic that acts fungicidally or fungistatically by binding to ergosterol in the cytoplasmic membrane of fungi. It exhibits activity, especially against yeast-like strains Candida albicans, Cryptococcus, and Hystoplasma.
Indications for Use
- Local treatment of vaginitis caused by susceptible microorganisms and nonspecific vaginitis.
- Prevention of infectious complications during gynecological procedures (before abortion, before and after diathermy coagulation of the cervix, before intrauterine diagnostic procedures, before childbirth).
Method of Use and Dosage
For adults, for vaginal use only. Insert one capsule deeply into the vagina before bedtime. The treatment course is 12 days. For the prevention of infectious complications, the treatment course is 6 days.
If you miss one or more doses, resume taking the medication at the usual dose.
To prevent the transmission of the disease, use personal hygiene items separately (washcloths, towels, and the like) and wear underwear made of natural cotton.
During treatment, do not use sanitary tampons, latex contraceptive caps, and spermicides.
To prevent re-infection, it is also necessary to simultaneously treat the sexual partner.
- Itching, burning, allergic contact dermatitis
- Systemic side effects of aminoglycosides (with prolonged use)
- Hypersensitivity to neomycin, other components of the drug, or aminoglycoside antibiotics
- First trimester of pregnancy
- Use of diaphragms or latex condoms
- Hypersensitivity to peanuts or soy
- Use in combination with spermicides
It is not recommended to use in combination with barrier contraception methods, as it may reduce the effectiveness of spermicides and increase the risk of condom breakage.
The duration of the drug’s use should be limited to prevent the development of resistance in specific disease-causing agents and the risk of reinfection.
Do not interrupt the course of treatment during menstruation.
This medication contains soybean oil and may cause allergic reactions (hives, anaphylactic shock).
During Pregnancy or Breastfeeding
Considering the presence of neomycin, which poses a risk of ototoxicity, and the potential for systemic absorption in this aminoglycoside group, the use of this drug is not recommended for pregnant women.
Given the digestive immaturity of newborns and the pharmacokinetic properties of this drug, it is not recommended during lactation.
Excessive and prolonged administration may lead to systemic effects (auditory and renal), especially in patients with renal insufficiency. Prolonged use also increases the risk of allergic dermatitis.