Vablys® (Dequalinium chloride vaginal tablets 10 mg)

Important safety
information

Indications and clinical use:

Vablys® (dequalinium chloride) is indicated for the treatment of bacterial vaginosis in adult women under 55 years of age. Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

Geriatrics (> 55 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for use in women over 55 years of age.

Contraindications:

  • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredients, or component of the applicator.
  • Patients with ulceration of the vaginal epithelium and the vaginal portion of the cervix.
  • Premenarchal patients.

Relevant warnings and precautions:

  • For vaginal use only.
  • There are no safety and efficacy data available on the re-treatment of patients who did not respond to or relapsed immediately after initial therapy with Vablys®. Patients should be advised to consult their physician if symptoms persist at the end of the treatment or in case of recurrence.
  • Anionic substances such as soaps, detergents and surfactants may reduce the antimicrobial activity of dequalinium chloride. Thus, concomitant intravaginal use of soaps, spermicides or vaginal douches (vaginal washes) is not recommended.
  • Increasing the daily dose or treatment duration of Vablys® may increase the risk of vaginal ulcerations.
  • The effects of Vablys® on fertility have not been studied. Vablys® should not be used within 48 hours before sexual intercourse if you would like to conceive.
  • Limited data is available with Vablys® use in pregnancy. Data from 7 clinical studies involving 481 pregnant patients did not demonstrate any adverse effect on the pregnancy or the foetus/neonate. Vablys® should not be used within 12 hours before birth to minimize exposure of the newborn.

Adverse reactions:

In clinical trials, the most common adverse reactions reported in ≥ 1% of patients treated with Vablys® were local reactions, including vaginal discharge (9.2%), vulvovaginal pruritus (4.9%), vaginal candidiasis (4.9%), vulvovaginal burning sensation (1.8%) and bacterial vulvovaginitis (0.6%).

For more information:

Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information that have not been discussed in this piece.

The Product Monograph is also available by contacting us: 1-888-666-0611 or [email protected].