Version May 2024
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely due to low systemic absorption.
Not indicated for patients >55 years of age.
Bacterial vaginosis (vaginal tablet): Intravaginal: Female: Refer to adult dosing. Not for use prior to menarche.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%: Genitourinary: Vaginal discharge (9%), vulvovaginal burning (2%), vulvovaginal candidiasis (5%), vulvovaginal pruritus (5%)
<1%:
Dermatologic: Fungal skin infection
Gastrointestinal: Nausea
Genitourinary: Bacterial vaginosis, vaginal hemorrhage, vaginal pain, vulvitis, vulvovaginitis
Nervous system: Headache
Postmarketing:
Dermatologic: Maceration of the skin (vaginal epithelium)
Gastrointestinal: Abdominal pain, vomiting
Genitourinary: Cystitis, uterine hemorrhage, vaginal dryness, vaginal ulcer
Hypersensitivity: Hypersensitivity reaction
Local: Localized erythema (vulvovaginal)
Miscellaneous: Fever
Hypersensitivity to dequalinium or any component of the formulation; ulceration of the vaginal epithelium and the vaginal portion of the cervix; premenarchal patients.
Concerns related to adverse effects:
• Vaginal ulceration: Vaginal ulceration may occur; risk may be increased with higher dosing or prolonged treatment duration.
Other warnings/precautions:
• Anionic substances: Intravaginal use of anionic substances (eg, soaps, detergents, surfactants) may reduce the activity of dequalinium; concomitant use of soaps, spermicides, and vaginal douches is not recommended.
• Appropriate use: Complete entire course of therapy even with resolution of vaginosis symptoms (itching, discharge, odor); relapse may occur with treatment <6 days. There is no efficacy or safety data on retreatment of patients who relapse or have lack of treatment response after initial therapy.
Not available in United States.
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Vaginal:
Vablys: 10 mg
Intravaginal: For intravaginal use only. Wash hands prior to opening blister pack and after insertion of tablet. In a lying position with legs slightly bent, insert 1 vaginal tablet deeply into the vagina at bedtime, using index and/or middle finger; may also be inserted with provided applicator.
Heavy bleeding during menstruation may result in a wash-out and lower local concentrations of dequalinium; therapy should be started 6 days before the next menses or immediately after menses. In the event treatment cannot be completed before the onset of menses, interrupt treatment and resume therapy after menses is complete. In cases of severe vaginal dryness, the vaginal tablet may not dissolve completely and may be discharged from the vagina intact. If this occurs, the vaginal tablet may be moistened with a drop of water prior to reinsertion to promote tablet dissolution. In addition, excipients may not dissolve completely; small tablet remnants may occasionally be found in undergarments. A sanitary napkin or panty liner should be used during treatment. Sexual intercourse should be avoided during treatment.
Note: Not approved in the United States.
Bacterial vaginosis: Treatment of bacterial vaginosis in adults <55 years of age.
None known.
There are no known significant interactions.
Data related to use with diaphragms, menstrual tampons and cups, spermicides, and vaginal douches are insufficient; concomitant use with condoms, intravaginal, or genitourinary devices is not recommended.
Do not administer dequalinium within 48 hours of intercourse in patients trying to conceive; effects on fertility have not been studied.
Outcome data following maternal use of dequalinium do not suggest adverse maternal or fetal effects (limited data) (Mendling 2016). Systemic exposure is expected to be negligible following intravaginal use. Do not administer intravaginal tablets within 12 hours before birth to limit potential newborn exposure.
It is not known if dequalinium is present in breast milk.
Systemic exposure is expected to be negligible following intravaginal use. The manufacturer recommends caution be used if administered to a lactating patient.
Quaternary ammonium antiseptic with anti-infective properties.
Absorption: Negligible.
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