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Antiseptic vaginal pessary 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 after vaginal administration. Fluomizin should only be used in pregnancy if clearly necessary. Systemic exposure of the breast-feeding woman is negligible, so no harmful effects on the breastfed newborn/infant are anticipated and it can be used during lactation if clinically needed. To minimise exposure of the newborn, vaginal tablets should not be used within 12 hours before birth. No studies on effects on fertility have been conducted in animals.

Dequalinium chloride

Brand names: Fluomizin

Dequalinium chloride is a topical antiseptic quaternary ammonium agent used intravaginally for the treatment of bacterial vaginosis.

Adult dose

Dose: Bacterial vaginosis (the treatment indication named in the SPC's own section 4.4 wording): one Fluomizin 10 mg vaginal tablet daily for six days
Route: Vaginal. The vaginal tablets 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
Frequency: Once daily for six days. The treatment should be interrupted during menstruation and resumed afterwards. Although relief of discharge and inflammation generally occurs within 24 to 72 hours, treatment should be continued even when there is no subjective discomfort (itching, discharge, smell) any more - a treatment shorter than six days could result in a relapse
Max: One 10 mg vaginal tablet daily for six days. Using a higher daily dose, or increasing the recommended treatment duration, might increase the risk of vaginal ulcerations
To minimise exposure of the newborn to dequalinium chloride, vaginal tablets should not be used within 12 hours before birth. There are no efficacy and safety data on re-treatment of patients who did not respond to, or relapsed immediately after, initial therapy - patients should be advised to consult their physician if symptoms persist at the end of treatment or in case of recurrence. There is a lack of data on efficacy and safety in women above 55 years of age, and no efficacy and safety data on the treatment of bacterial vaginosis in women aged less than 18 years or more than 55 years. Practical points from section 4.2: Fluomizin contains excipients that do not dissolve completely, so remains of the tablet are occasionally found in the underwear - this is of no importance for efficacy, and patients should use a sanitary towel or panty liner (there is no change in colour of the underwear). In rare cases of a very dry vagina the tablet may not dissolve and may be discharged intact, making treatment sub-optimal; to prevent this the tablet can be moistened with a drop of water before insertion.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Ulceration of the vaginal epithelium and of the vaginal portion of the cervix
  • Young girls who have not yet had their first menstruation, and who have thus not reached sexual maturity, must not use Fluomizin
  • There is a lack of data on the efficacy and safety of dequalinium chloride in children below 18 years

Side effects

  • Common: vaginal candidiasis
  • Common: vaginal discharge, vulvovaginal pruritus, vulvovaginal burning sensation
  • Uncommon: bacterial vaginitis, fungal skin infection, vulvitis, vulvovaginitis
  • Uncommon: vaginal haemorrhage, vaginal pain
  • Uncommon: headache, nausea
  • Uncommon: allergic reactions with symptoms such as urticaria, erythema, exanthema, swelling, rash or pruritus
  • Not known: cystitis
  • Not known: ulceration and maceration of the vaginal epithelium, uterine bleeding, redness, vaginal dryness
  • Not known: fever

Interactions

  • Anionic substances such as soaps, detergents and surfactants can reduce the antimicrobial activity of dequalinium chloride - 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 interaction with non-latex condoms and other intravaginal devices such as diaphragms - concomitant use is not recommended for at least 12 hours following the treatment

Monitoring

  • Advise the patient to consult their physician if symptoms persist at the end of the treatment course or in case of recurrence - there are no efficacy and safety data on re-treatment after non-response or immediate relapse
  • Do not exceed the daily dose or the recommended treatment duration, as this might increase the risk of vaginal ulcerations
  • Do not use within 12 hours before birth, to minimise exposure of the newborn

Clinical monograph

How it works

It is a cationic surfactant that disrupts the cell membrane and reduces the surface tension of bacterial cells, producing a broad-spectrum antibacterial and antifungal effect against vaginal pathogens.

Prescribing in practice

  • Avoid use during menstruation or before the cervix is closed, and do not use in young women who have not yet had their first period, as efficacy and safety depend on appropriate vaginal placement.
  • It offers a non-antibiotic option for bacterial vaginosis, which may be useful where antibiotic resistance or intolerance is a concern.
  • Soap can inactivate the agent, so concurrent use of soap-based intimate washes should be avoided during treatment.

Monitoring

Routine laboratory monitoring is not required; review the patient if symptoms persist or recur after completing the course.

Counselling the patient

  • Insert the tablet high into the vagina, ideally at night when lying down, for the full prescribed course.
  • Mild local irritation or discharge can occur and usually settles; seek advice if symptoms worsen.
  • Complete the full course even if symptoms improve early.

Evidence & guidelines

Clinical studies have shown dequalinium chloride to be comparable in efficacy to topical antibiotics such as clindamycin for bacterial vaginosis.

Reference: BASHH BV guideline; NICE CKS; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.