What is Fluomizin used for?

Fluomizin 10 mg vaginal tablets are indicated for the treatment of Bacterial vaginosis (see section 4.4) Consideration should be given to official guidance on the appropriate use of antibacterial agents.

What is the active ingredient in Fluomizin?

Dequalini chloridum (Dequalini chloridum)

What pharmaceutical form is Fluomizin available in?

Fluomizin: Tabletki dopochwowe 10 mg (dopochwowa)

Is Fluomizin OTC or prescription only?

Fluomizin requires a doctor's prescription.

What are the side effects of Fluomizin?

In clinical trials, the following undesirable effects possibly or probably related to dequalinum chloride have been reported. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Not known (cannot be estimated from the available data) Infections and infestations • vaginal candidiasis • bacterial vaginitis, • fungal skin infection, • vulvitis, • vulvovaginit

Who should NOT take Fluomizin?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ulceration of the vaginal epithelium and the vaginal portion of the cervix. Young girls who have not yet had their first menstruation, and thus did not reach sexual maturity must not use Fluomizin.

Does Fluomizin interact with other medications?

Anionic substances such as soaps, detergents and surfactants can reduce the antimicrobial activity of dequalinium chloride. Thus, concomitant intravaginal use of soaps, spermicides or vaginal douches (vaginal washes) is not recommended. Fluomizin 10 mg vaginal tablets do not impair the functionality of latex condoms. There are no data on the interaction with non-latex condoms and other intravaginal devices such as diaphragms. Thus, concomitant use of non-latex condoms and other

Can Fluomizin be used during pregnancy?

Pregnancy Limited data from four clinical studies in 181 pregnant patients did not suggest adverse effects on the pregnancy or on the foetus / neonate. No reproductive toxicity studies have been conducted in animals because of the expected low systemic exposure to dequalinium chloride after vaginal administration. Fluomizin should only be used in pregnancy if clearly necessary. Breast-feeding Systemic exposure of the breast-feeding women to Fluomizin is negligible. Therefore, n

Who manufactures Fluomizin?

Gedeon Richter Polska Sp. z o.o. (Węgry)

What ATC class does Fluomizin belong to?

Fluomizin: ATC G01AC05. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Fluomizin

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Gynaecological anti-infective and antiseptic, Quinoline derivatives ATC code: G01A C05 Dequalinium chloride is an anti-infective and antiseptic agent belonging to the class of quaternary ammonium compounds. Mechanism of Action Dequalinium chloride is a surface-active substance.‍‍‍‍‍‍‍ The primary mechanism of action is an increase in bacterial cell permeability and the subsequent loss of enzyme activity, finally resulting in cell death. Dequalinium chloride exhibits a rapid bactericidal activity. Dequalinium chloride in vaginal tablets exerts its action locally within the vagina. Pharmacokinetic/pharmacodynamics relationship No major PK/PD determinant of efficacy has been established for Fluomizin. As the bactericidal effect of dequalinium chloride occurs within 30 to 60 minutes, the maximum local concentration within the first hour after application is considered crucial for the efficacy. Mechanism(s) of resistance The mechanisms resulting in the inherent resistance of some pathogens are not known. No mechanisms of acquired resistance have been observed thus far. Breakpoints No Breakpoints for dequalinium chloride are available by any recommending body and no relationship between minimal inhibitory concentrations and the clinical efficacy has been established. Thus, the information on susceptibility in the table below is descriptive and is based on the concentrations achievable in the vagina (see section 5.2) and respective MIC data of the pathogens. The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable. Commonly susceptible species Aerobic Gram-positive bacteria Enterococcus faecalis Lactobacillus spp . Staphylococcus aureus Streptococcus agalactiae (Group B streptococci) Streptococcus pyogenes (Group A streptococci) Aerobic Gram-negative bacteria Enterobacter spp . Escherichia coli Klebsiella s pp . Pseudomonas spp . Serratia spp. Anaerobic bacteria Atopobium vaginae Bacteroides spp. Fusobacteria Gardnerella vaginalis Prevotella spp . Peptostreptococci Poryphyromonas spp Species for which acquired resistance may be a problem None known Inheritantly resistant organisms Gram-negative bacteria Proteus sp. Chlamydia trachomatis Other micro-organisms Trichomonas vaginalis

Fluomizin

User Reviews