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.)
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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.