FLUOMIZIN Dequalinium Chloride 10 mg Vaginal Tablet 6's
RXDRUG-DR-XY31774
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Vaginal infection of bacterial and mycotic origin (e.g.bacterial vaginosis and candidiasis).
Trichomoniasis.
Achievement of asepsis before gynaecological operations and deliveries.
Trichomoniasis.
Achievement of asepsis before gynaecological operations and deliveries.
Dosage/Direction for Use
One vaginal tablet daily for six days.
Dequalinium chloride should be inserted deeply into the vagina in the evenings before retiring. This is best performed in a reclining position with the legs slightly bent.
The treatment should be interrupted during menstruation and resumed afterwards.
The treatment should be continued even when there is no subjective discomfort (itching, discharge, smell) anymore. A treatment less than six days could result in a relapse.
Or as prescribed by the physician.
Dequalinium chloride should be inserted deeply into the vagina in the evenings before retiring. This is best performed in a reclining position with the legs slightly bent.
The treatment should be interrupted during menstruation and resumed afterwards.
The treatment should be continued even when there is no subjective discomfort (itching, discharge, smell) anymore. A treatment less than six days could result in a relapse.
Or as prescribed by the physician.
Overdosage
Application of more than 1 vaginal tablet will not increase the efficacy of Dequalinium chloride vaginal tablets. This will rather result in an increase of side effects. However, no severe side effects after using an overdose of Dequalinium chloride vaginal tablets have been reported.
In the case of an overdose, a vaginal lavage should be performed to remove rest of the tablets.
In the case of an overdose, a vaginal lavage should be performed to remove rest of the tablets.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Ulceration of the vaginal epithelium and portio.
Young girls who have not reached sexual maturity should not use Dequalinium chloride vaginal tablets.
Ulceration of the vaginal epithelium and portio.
Young girls who have not reached sexual maturity should not use Dequalinium chloride vaginal tablets.
Special Precautions
Read carefully the instructions before use. Consult the doctor for further information.
Use upon doctor's prescription only.
Effects on ability to drive and use machines: Not relevant.
Use upon doctor's prescription only.
Effects on ability to drive and use machines: Not relevant.
Use In Pregnancy & Lactation
Dequalinium chloride vaginal tablets can be used during pregnancy and lactation.
However, as with medicinal products in general, caution should be exercised when prescribing Dequalinium chloride vaginal tablets to pregnant women in the first trimester.
Data on a limited number of exposed pregnancies in a clinical study with dequalinium chloride and in a drug utilization study with Dequalinium chloride vaginal tablets indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/new-born child.
Data from post marketing surveillance on a number of exposed pregnancies (estimated 0.5 to 1.1 million) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/new-born child.
No animal studies have been conducted with dequalinium chloride. However, animal studies with quaternary ammonium compounds have not shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data 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.
However, as with medicinal products in general, caution should be exercised when prescribing Dequalinium chloride vaginal tablets to pregnant women in the first trimester.
Data on a limited number of exposed pregnancies in a clinical study with dequalinium chloride and in a drug utilization study with Dequalinium chloride vaginal tablets indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/new-born child.
Data from post marketing surveillance on a number of exposed pregnancies (estimated 0.5 to 1.1 million) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/new-born child.
No animal studies have been conducted with dequalinium chloride. However, animal studies with quaternary ammonium compounds have not shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data 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, patient should be advised to seek medical attention as soon as possible.
Local irritation reactions, such as bleeding surface defects (erosions) in the vagina, were reported in individual cases (0.002%). In these cases, the vaginal surface (vaginal epithelium) was predamaged, e.g. in consequence of an oestrogen deficit or distinct inflammation. In these cases, the treatment should be stopped, and patient should be advised to seek medical attention.
Some very rare cases (0.0003%) of fever have been reported.
Patient should be advised to inform doctor or pharmacist of any adverse effects related to the drug use.
Local irritation reactions, such as bleeding surface defects (erosions) in the vagina, were reported in individual cases (0.002%). In these cases, the vaginal surface (vaginal epithelium) was predamaged, e.g. in consequence of an oestrogen deficit or distinct inflammation. In these cases, the treatment should be stopped, and patient should be advised to seek medical attention.
Some very rare cases (0.0003%) of fever have been reported.
Patient should be advised to inform doctor or pharmacist of any adverse effects related to the drug use.
Caution For Usage
Instructions for use / handling: Dequalinium chloride vaginal tablets contains excipients which do not dissolve completely, such that remains of the tablet are occasionally found in the panties. This is of no importance for the efficacy of Dequalinium chloride vaginal tablets.
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 intact tablet. As consequence, the treatment is not optimal. However, this is not harmful to the vagina. For prevention, the vaginal tablet can be moistened with a drop of water before insertion into a very dry vagina.
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 Dequalinium chloride vaginal tablets.
Incompatibilities: Dequalinium chloride vaginal tablet is incompatible with soaps and other anionic surfactants, with phenol and with chlorocresol.
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 intact tablet. As consequence, the treatment is not optimal. However, this is not harmful to the vagina. For prevention, the vaginal tablet can be moistened with a drop of water before insertion into a very dry vagina.
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 Dequalinium chloride vaginal tablets.
Incompatibilities: Dequalinium chloride vaginal tablet is incompatible with soaps and other anionic surfactants, with phenol and with chlorocresol.
Storage
Do not store above 30°C.
Shelf-Life: 36 months.
Shelf-Life: 36 months.
Action
Pharmacotherapeutic group: Gynaecological anti-infective and antiseptic. ATC code: G01A C05.
Pharmacology: Pharmacodynamics: Dequalinium chloride vaginal tablets 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). (See table.)
Pharmacology: Pharmacodynamics: Dequalinium chloride vaginal tablets 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). (See table.)
After dissolution of a Dequalinium chloride vaginal tablet (10 mg dequalinium chloride) in an estimated 2.5 to 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, causing cell death.
Dequalinium chloride in vaginal tablets exerts its action locally within the vagina. Marked relief of discharge and inflammation generally occurs within 24 to 72 hours.
The efficacy of Dequalinium chloride vaginal tablets in the treatment of vaginal infections of various genesis has 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 seems 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 human pharmacokinetic data for dequalinium chloride available.
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 Dequalinium chloride vaginal tablets. However, developmental toxicity studies with quaternary ammonium compounds did not reveal evidence of embryofoetal toxicity.
Local tolerance: A study in rabbits showed the good vaginal tolerance of Dequalinium chloride vaginal tablets.
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, causing cell death.
Dequalinium chloride in vaginal tablets exerts its action locally within the vagina. Marked relief of discharge and inflammation generally occurs within 24 to 72 hours.
The efficacy of Dequalinium chloride vaginal tablets in the treatment of vaginal infections of various genesis has 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 seems 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 human pharmacokinetic data for dequalinium chloride available.
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 Dequalinium chloride vaginal tablets. However, developmental toxicity studies with quaternary ammonium compounds did not reveal evidence of embryofoetal toxicity.
Local tolerance: A study in rabbits showed the good vaginal tolerance of Dequalinium chloride vaginal tablets.
MedsGo Class
Preparations for Vaginal Conditions
Features
Brand
Fluomizin
Full Details
Dosage Strength
10 mg
Drug Ingredients
- Dequalinium Chloride
Drug Packaging
Vaginal Tablet 6's
Generic Name
Dequalinium Chloride
Dosage Form
Vaginal Tablet
Registration Number
DR-XY31774
Drug Classification
Prescription Drug (RX)
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