Fluomizin

Fluomizin

dequalinium

Manufacturer:

Medinova

Distributor:

DKSH
Full Prescribing Info
Contents
Dequalinium Cl.
Description
Each vaginal tablet also contains the following excipients: Lactose monohydrate, microcrystalline cellulose and magnesium stearate.
Action
Pharmacotherapeutic Group: Gynaecological anti-infective and antiseptic. ATC Code: G01AC05.
Pharmacology: Pharmacodynamics: Fluomizin contains dequalinium chloride, a quaternary ammonium compound with a broad antimicrobial spectrum against different gram-positive and gram-negative bacteria, fungi and protozoa (Trichomonas vaginalis).
The in vitro activity of dequalinium chloride against the following vaginally-important microorganisms was established and expressed as minimum inhibition concentration (MIC).
Gram-Positive Bacteria MIC (mg/L): Group B streptococci 2-8; Staphylococcus aureus 0.2-10; Group A streptococci 0.25-20; Listeria sp 4-32; Peptostreptococci 1-32; Group D streptococci 0.2-64.
Fungi MIC (mg/L): Candida tropicalis 0.2-50; Candida albicans 0.2-200; Candida glabrata 0.2-256; Candida krusei 128.
Gram-Negative Bacteria MIC (mg/L): Fusobacteria 32-64; Gardnerella vaginalis 2-256; Echerichia coli 1-400; Serratia sp 3.1-400; Klebsiella sp 3.1-400; Pseudomonas sp 5-400; Bacteroides sp/Prevotella sp 64-512; Proteus sp 20->1024.
Protozoa MIC (mg/L): Trichomonas vaginalis 28.8-400.
After dissolution of a Fluomizin vaginal tablet (dequalinium chloride 10 mg) in an estimated 2.5-5 mL of vaginal fluid, the dequalinium chloride concentration in the vaginal fluid is 4000 to 2000 mg/L, which is higher as the MIC90 of all tested pathogenic microrganisms.
Development of resistance of microorganisms to dequalinium chloride has not been reported.
As for other surface-active compounds, the primary mode of action of dequalinium chloride is the enhancement of cell permeability and the subsequent loss of enzymatic activity which causes cell death.
Dequalinium chloride in vaginal tablets exerts its action locally within the vagina. Marked relief of discharge and inflammation generally occurs within 24-72 hrs.
The efficacy of Fluomizin in the treatment of vaginal infections of various origin have been shown by an active controlled, double-blind clinical study.
Pharmacokinetics: Preclinical data from rabbits indicate that dequalinium chloride is absorbed only to a very small amount after vaginal application.
Distribution is observed into the liver, kidney and lung. Dequalinium chloride appears to be metabolised to the 2,2'-dicarboxylic acid derivate and excreted in the non-conjugated form via faeces.
In view of the negligible vaginal absorption, there are no available human pharmacokinetic data for dequalinium chloride.
Toxicology: Preclinical Safety Data: Considering the minimal vaginal absorption of dequalinium chloride, no acute or chronic toxicity is to be expected.
No reproduction toxicity studies have been conducted with Fluomizin. However, developmental toxicity studies with quarternary ammonium compounds did not reveal evidence of embryofoetal toxicity.
Local Tolerance: A study in rabbits showed the good vaginal tolerance of Fluomizin.
Indications/Uses
Vaginal infection of bacterial and mycotic origin (eg, bacterial vaginosis and candidiasis).
Trichomoniasis.
Achievement of asepsis before gynaecological operations and deliveries.
Dosage/Direction for Use
1 vaginal tab daily for 6 days.
The treatment should be interrupted during menstruation and resumed afterwards.
The treatment should be continued even when subjective discomfort is no longer perceived (itching, discharge, smell). A treatment <6 days could result in a relapse.
Administration: The vaginal tablets should be inserted deeply into the vagina in the evenings before bedtime. This is best performed in a reclining position with the legs slightly bent.
Overdosage
Application of >1 vaginal tablet will not increase the efficacy of Fluomizin. This will rather result in an increase of side effects.
However, no severe side effects after an overdosage of Fluomizin has been reported. In the case of overdosage, a vaginal lavage should be performed to remove the remaining tablets.
Contraindications
Hypersensitivity to dequalinium chloride or to any of the excipients of Fluomizin.
Ulceration of the vaginal epithelium and portio.
Young girls who have not reached sexual maturity.
Special Precautions
Fluomizin contains excipients which do not dissolve completely, such that remains of the tablet could occasionally be found in the underwear. This is of no importance for the efficacy of Fluomizin.
In rare cases of a very dry vagina, it is possible that the vaginal tablet does not dissolve and is discharged by the vagina as an intact tablet. As a consequence, the treatment is not optimal. However, this is not considered harmful to the vagina.
The vaginal tablet can be moistened with a drop of water before insertion into a very dry vagina for the prevention of such situations.
Patients should use a sanitary towel or panty liner. There is no change in colour of the underwear. Patients should be instructed to change their underwear and flannel daily and launder them at a temperature of at least 80°C. Patients should not use vaginal douches or rinses during treatment with Fluomizin.
Effects on the Ability to Drive or Operate Machinery: Not relevant.
Use in pregnancy & lactation: Fluomizin can be used during pregnancy and lactation.
However, as with medicinal products in general, caution should be exercised when prescribing Fluomizin to pregnant women in the 1st trimester.
Data on a limited number of exposed pregnancies in a clinical study with dequalinium chloride (55) and in a drug utilization study with Fluomizin (60) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
Data from post-marketing surveillance on a number of exposed pregnancies (estimated 0.5-1.1 million) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
No animal studies have been conducted with dequalinium chloride. However, animal studies with quaternary ammonium compounds have not shown reproductive toxicity (see Toxicology under Actions).
No data regarding the uptake of dequalinium chloride into breast milk are available. Based on the absorption data and the fact that the duration of the treatment is only 6 days, adverse effects on the foetus or newborn are improbable.
Use In Pregnancy & Lactation
Fluomizin can be used during pregnancy and lactation.
However, as with medicinal products in general, caution should be exercised when prescribing Fluomizin to pregnant women in the 1st trimester.
Data on a limited number of exposed pregnancies in a clinical study with dequalinium chloride (55) and in a drug utilization study with Fluomizin (60) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
Data from post-marketing surveillance on a number of exposed pregnancies (estimated 0.5-1.1 million) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
No animal studies have been conducted with dequalinium chloride. However, animal studies with quaternary ammonium compounds have not shown reproductive toxicity (see Toxicology under Actions).
No data regarding the uptake of dequalinium chloride into breast milk are available. Based on the absorption data and the fact that the duration of the treatment is only 6 days, adverse effects on the foetus or newborn are improbable.
Adverse Reactions
General Disorders and Administration Site Conditions: In rare cases, pruritus, burning or redness can be observed. However, these adverse reactions can also be associated with the symptoms of the vaginal infection. In these cases, it is not necessary to stop the treatment. However, if the complaints persist, the patient should be advised to seek medical attention as soon as possible.
Local irritation reactions eg, bleeding surface defects (erosions) in the vagina were reported in individual cases (0.002%). In these cases, the vaginal surface (vaginal epithelium) was predamaged eg, in consequence of an oestrogen deficit or distinct inflammation. The treatment should be stopped and the patient should be advised to seek medical attention in these situations.
Some very rare cases (0.0003%) of fever have been reported.
Drug Interactions
No interactions are known.
Patients should be advised to inform a physician or pharmacist if they are taking or have recently taken any other medicines even those not prescribed.
Incompatibilities: Fluomizin is incompatible with soaps and other anionic surfactants.
Storage
Do not store above 30°C.
Shelf-Life: 36 months.
ATC Classification
G01AC05 - dequalinium ; Belongs to the class of quinolone derivative antiinfectives. Used in the treatment of gynecological infections.
Presentation/Packing
Vag tab 10 mg (white, oval, biconvex) x 6's.
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