Instructions Fluomizin vaginal tablets 10 mg No. 6
Composition
active ingredient: dequalinium chloride;
1 vaginal tablet contains 10 mg of dequalinium chloride;
Excipients: lactose monohydrate; microcrystalline cellulose; magnesium stearate.
Dosage form
Vaginal tablets.
Main physicochemical properties: white or almost white oval biconvex tablets.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology.
ATX code G01A C05.0 Zurich, Switzerland.
Pharmacological properties
Pharmacodynamics
Fluomizin contains dequalinium chloride, a quaternary ammonium compound with a broad antimicrobial spectrum of action against various gram-positive and gram-negative bacteria, fungi, and protozoa (Trichomonas vaginalis).
Mechanism of action
Dequalinium chloride is a surfactant. The main mechanism of action of dequalinium chloride is to increase the permeability of the bacterial cell and the subsequent loss of enzyme activity, which leads to cell death.
Dequalinium chloride exhibits rapid bactericidal and fungicidal effects.
Dequalinium chloride in vaginal tablets acts locally in the vagina. A noticeable reduction in discharge and inflammation usually occurs after 24–72 hours.
Pharmacokinetics/pharmacodynamics relationship
No pharmacokinetic/pharmacodynamic limiting effect on the efficacy of Fluomizin has been established. Since the bactericidal effect of dequalinium chloride occurs within 30–60 minutes, the maximum local concentration within the first hour after application is crucial for efficacy.
Resistance mechanisms
The mechanisms leading to the emergence of primary resistance in pathogenic microorganisms have not been identified. The development of acquired resistance of microorganisms to dequalinium chloride has not been reported.
Sensitivity thresholds
There are no established threshold values and no relationship between minimum inhibitory concentrations (MICs) and clinical efficacy has been established.
Therefore, the information on the susceptibility of microorganisms presented below is based on the concentrations achieved in the vagina (see section "Pharmacokinetics") and the corresponding data on the MIC of pathogenic microorganisms.
Spectrum of antimicrobial activity
Typically sensitive species
Aerobic Gram-positive bacteria
Enterococcus faecalis,
Listeria spp.,
Staphylococcus aureus,
Streptococcus agalactiae (group B streptococci),
Streptococcus pyogenes (group A streptococci)
Aerobic Gram-negative bacteria
Enterobacter spp.,
Escherichia coli,
Klebsiella spp.,
Pseudomonas spp.,
Serratia spp.
Anaerobic bacteria
Atopobium vaginae,
Bacteroides spp.,
Fusobacteria,
Gardnerella vaginalis,
Prevotella spp.,
Peptostreptococci,
Porphyromonas spp.
Mushrooms
Candida albicans,
Candida tropicalis,
Candida glabrata,
Candida krusei
Organisms with primary resistance
Gram-negative bacteria
Proteus sp.,
Chlamydia trachomatis
Pharmacokinetics
After dissolving a vaginal tablet of Fluomizin (10 mg of dequalinium chloride) in 2.5–5 ml of vaginal fluid, the concentration of dequalinium chloride in the vaginal fluid is 4000–2000 mg/l, which is higher than the MIC90 of all tested pathogenic microorganisms.
The results of these preclinical studies indicate that only a small amount of dequalinium chloride is absorbed after vaginal administration.
Since vaginal absorption is negligible, there are no data on the pharmacokinetics of dequalinium chloride in humans.
Indication
Vaginal infections of bacterial and fungal origin; bacterial vaginosis; candidiasis.
Contraindication
Hypersensitivity to the active substance or to any of the excipients; ulcers of the vaginal epithelium and the vaginal part of the cervix; Do not use in young girls who have not had their first menstruation and who have not reached puberty.
Interaction with other medicinal products and other types of interactions
Soap and other surfactants may reduce the antimicrobial effect of dequalinium chloride. Therefore, intravaginal use of soap, spermicides, and douching is not recommended during treatment. Fluomizin does not affect the functionality of latex condoms. There is no data on interactions with non-latex condoms and other intravaginal devices such as diaphragms.
Therefore, the use of non-latex condoms and other intravaginal devices is not recommended during treatment and for at least 12 hours after treatment.
Application features
Fluomizin contains excipients that do not dissolve completely. Tablet residues can sometimes be found on underwear. This does not affect the effectiveness of Fluomizin.
Sometimes, in cases where vaginal dryness is observed, there is a possibility that the vaginal tablet does not dissolve and is released from the vagina whole. As a result, such treatment is not effective. To prevent this, before inserting the tablet into a dry vagina, you can moisten the tablet with a small amount of water.
To minimize the risk of exposure to dequalinium chloride in the newborn, vaginal tablets should not be used within 12 hours before delivery.
There are no data on the efficacy and safety of re-treatment in patients who have failed to respond or who have relapsed immediately after initial therapy with the drug. Patients should be advised to contact their physician if symptoms persist at the end of treatment or if disease relapses.
Exceeding the daily dose or recommended duration of treatment increases the risk of vaginal epithelial ulceration.
There are no data on the effectiveness and safety of treating bacterial vaginosis in women under 18 years of age or after 55 years of age.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the ability to influence the reaction rate when driving vehicles or working with other mechanisms have not been conducted.
Use during pregnancy or breastfeeding
Pregnancy
Fluomizin can be used during pregnancy or breastfeeding. However, caution should be exercised when prescribing Fluomizin to pregnant women in the first trimester of pregnancy. Data obtained from the use of dequalinium chloride in pregnant women during a clinical study and in a study of the use of the drug Fluomizin indicate the absence of undesirable effects of dequalinium chloride on pregnancy or the health of the fetus/newborn child.
Data from post-marketing studies conducted during pregnancy (estimated at 1.1 million exposures) indicate no adverse effects of dequalinium chloride on pregnancy or the health of the fetus/newborn child.
There is no data on the penetration of dequalinium chloride into breast milk.
Given the evidence of lack of absorption and the fact that treatment lasts only 6 days, adverse effects on the fetus or newborn are unlikely.
Animal reproductive toxicity studies have not been conducted due to the expected low degree of absorption of dequalinium chloride following vaginal administration.
Fluomizin should be used during pregnancy if necessary.
Breast-feeding
Since the absorption of Fluomizin is insignificant, harmful effects on the newborn/infant are unlikely.
Fluomizin can be used during lactation if clinically necessary.
Fertility
Fertility studies in animals have not been conducted.
Method of administration and doses
It is recommended to use 1 vaginal tablet daily for 6 days. The vaginal tablet should be inserted deep into the vagina in the evening before going to bed. It is best to do this while lying on your back with your legs slightly bent.
Treatment should be stopped during menstruation and continued after menstruation has stopped.
Although the reduction of discharge and inflammation usually occurs after 24–72 hours, it is necessary to continue treatment even if there is no longer any discomfort (itching, discharge, odor). Treatment lasting less than 6 days may lead to relapse. The course of treatment is 6 days.
Children
Not recommended for use in children.
Overdose
No cases of overdose have been reported. However, exceeding the daily dose may lead to the formation of ulcers of the vaginal epithelium.
Adverse reactions
The following adverse reactions were reported during clinical trials and are possibly related to dequalinium chloride.
The list of adverse reactions is given by system organ class and frequency: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), frequency unknown - these adverse reactions have been reported during post-marketing use.
From the genitals and mammary glands.
Common: vaginal discharge, vulvovaginal itching, burning sensation in the vulvovaginal area.
Uncommon: vaginal bleeding, vaginal pain.
Frequency unknown: ulceration and maceration of the vaginal epithelium, uterine bleeding, redness, vaginal dryness.
Infectious and parasitic diseases.
Common: vaginal candidiasis.
Uncommon: bacterial vaginitis, fungal skin infection, vulvitis, vulvovaginitis.
Frequency unknown: cystitis.
From the nervous system.
Uncommon: headache.
From the gastrointestinal tract.
Uncommon: nausea.
General complications and injection site reactions.
Frequency unknown: allergic reactions with symptoms of urticaria, erythema, exanthema, edema, rash or itching, fever.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 °C. Store in the original packaging. Keep out of the reach of children.
Packaging
6 tablets in a blister, 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Medinova AG/Medinova AG.
Location of the manufacturer and its business address
Eggbuhlstrasse 28, 8050 Zurich, Switzerland/ Eggbuhlstrasse 28, 805
