Fluomizin
Producer: Medinova Ltd. (Medinova Ltd.) Switzerland
Code of automatic telephone exchange: G01AC05
Release form: Firm dosage forms. Tablets are vaginal.
General characteristics. Structure:
Active agent: dekvaliniya chloride of 10 mg
Excipients: lactoses monohydrate, cellulose microcrystallic, magnesium stearate.
Pharmacological properties:
Pharmacodynamics. Fluomizin contains a dekvaliniya chloride, compound of quarternary ammonium with a wide range of antimicrobic activity against many gram-positive and gram-negative bacteria, mushrooms and elementary (Trichomonas vaginalis). For a dekvaliniya of chloride antimicrobic activity of in vitro against microorganisms which can contain in a vagina was defined. This activity is expressed as MPK.
MPK, mg/l | MPK, mg/l | ||
---|---|---|---|
Gram-positive bacteria Streptococci of group B Staphylococcus aureus Streptococci of group A Listeria spp. Peptostreptococci Streptococci of group D Mushrooms Candida tropicalis Candida albicans Candida glabrata Candida krusei |
2–8 0,2–10 0,25–20 4–32 1–32 0,2–64 0,2–50 0,2–200 0,2–256 128 |
Gram-negative bacteria Fusobacterium Gardnerella vaginalis Escherichia coli Serratia spp. Klebsiella spp. Pseudomonas spp. Bacteroides spp./Prevotella spp. Proteus spp. Protozoa Trichomonas vaginalis |
32–64 2,0–256 1–400 3,1–400 3,1–400 5–400 64–512 20–> 1024 28,8–400 |
After dissolution of a vaginal tablet of Fluomizin (10 mg a chloride dekvaliniya) in 2,5–5 ml of vaginal liquid concentration the chloride dekvaliniya in it makes 4000–2000 mg/l that above, than MPK90 for all studied pathogenic microorganisms.
About development of resistance of microorganisms to a dekvaliniya to chloride it was not reported.
As well as at other surfactants, action a dekvaliniya of chloride is based on strengthening of permeability of a cell and the subsequent loss of enzymatic activity which causes death of a cell.
Dekvaliniya chloride in the form of a vaginal tablet acts locally in a vagina. Noticeable reduction of allocations and an inflammation note in 24–72 h.
Because vaginal absorption is insignificant, the person has no data on pharmacokinetics a chloride dekvaliniya.
Indications to use:
Vaginal infections of a bacterial and fungal origin (for example bacterial vaginosis and mycotic vulvovaginitis); trichomoniasis; sanitation before gynecologic operations and childbirth.
Route of administration and doses:
It is recommended to apply 1 vaginal tablet every day for 6 days. The vaginal tablet is entered deeply into a vagina in the evening before going to bed. During periods treatment should be suspended and continued after its termination.
Therapy is continued even if sensations of discomfort (the itch, allocations, began to smell) are absent. A course of treatment — 6 days. Treatment duration can lead less than 6 days to a recurrence.
Features of use:
Fluomizin contains excipients which completely are not dissolved. The tablet remains sometimes can be found on underwear. It does not influence Fluomizin's efficiency.
Sometimes at dryness of a vagina there is a probability that the vaginal tablet is not dissolved and allocated from a vagina whole. For prevention of it before introduction (at dryness of a vagina) the tablet should be humidified with a small amount of water.
Period of pregnancy and feeding by a breast. Fluomizin it is possible to apply during pregnancy and feeding by a breast. Clinical trials did not reveal undesirable influences a chloride dekvaliniya on the course of pregnancy and/or on health of the fruit/newborn. Data of the post-market researches conducted at use of drug during pregnancy (by estimates, from 0,5 to 1,1 million cases), indicate lack of adverse influence a chloride dekvaliniya on the course of pregnancy or health of the fruit/newborn. There are no data on penetration a chloride dekvaliniya in breast milk.
Fluomizin does not influence ability to control of vehicles and work with other mechanisms.
Side effects:
In some cases there can be an itch, burning or a hyperemia. At persons with hypersensitivity allergic reactions, skin rashes are possible. However these side effects can also be symptoms of a vaginal infection.
In individual cases local reactions of irritation, such as bleeding of erosion of a mucous membrane of a vagina are possible. In these cases the previous damage of a surface of an epithelium of a vagina owing to deficit of estrogen or a local inflammation is noted. Very seldom reported about fever.
Interaction with other medicines:
Are unknown. Fluomizin is incompatible with soap and other anion surfactants.
Contraindications:
Hypersensitivity to a dekvaliniya to chloride or any component of drug, cankers of a vaginal epithelium and a neck of uterus, to girls before achievement of puberty.
Overdose:
About cases of overdose of drug it was not reported.
Storage conditions:
To store at a temperature not above 25 °C.
Issue conditions:
According to the recipe
Packaging:
In packagings planimetric cell aluminum foil / PVC on 6 pieces; in a pack cardboard 1 packaging planimetric cell.