Dequalinium Chloride

Registered South African indications: 

• Bacterial vaginosis

Contraindications

Registered contraindications in South Africa & other jurisdictions

• Hypersensitivity to dequalinium chloride or to any of the excipients
• Ulceration of the vaginal epithelium and the vaginal portion of the cervix
• Young girls who have not yet had their first menstruation, and thus did not reach sexual maturity

Cautions

Recommendations in South Africa & other jurisdictions

Before birth

• Avoid use of vaginal tablets within 12 hours to minimize newborn exposure to dequalinium chloride

Retreatment with dequalinium chloride

• No efficacy and safety data available. Consult physician if symptoms persist or recur after treatment

Increased dosage and treatment duration

• Might increase risk of vaginal ulcerations

Age restrictions

• No efficacy and safety data for bacterial vaginosis treatment in women under 18 or over 55

Intravaginal use of anionic substances

• Concomitant use with soaps, spermicides, or vaginal douches can reduce antimicrobial activity of dequalinium chloride

Latex condoms

• Dequalinium chloride does not impair functionality

Non-latex condoms and intravaginal devices

• No data on interaction. Avoid use for at least 12 hours post-treatment

Forms avail. in SA and covered in this monograph: vat

Registered indications and dosages in South Africa & other jurisdictions

Infections caused by: Aerobic Gram-positive bacteria: Enterococcus faecalis, Lactobacillus spp., Staphylococcus aureus, Streptococcus agalactiae (Group B streptococci), Streptococcus pyogenes (Group A streptococci); Aerobic Gram-negative bacteria: Enterobacter spp., Escherichia coli, Klebsiella spp., Pseudomonas spp., Serratia spp.; Anaerobic bacteria: Atopobium vaginae, Bacteroides spp., Fusobacteria, Gardnerella vaginalis, Prevotella spp., Peptostreptococci, Poryphyromonas spp

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Consideration should be given to official guidance on the appropriate use of antibacterial medicines

Bacterial vaginosis

• Vaginal (tab): Initial: 1 tab daily for 6 days, inserted deeply into the vagina at bedtime. The treatment should be interrupted during menstruation and resumed afterwards. Continue treatment for full 6 days even if symptoms (itching, discharge, smell) have resolved

Advice for patients:
In case of very dry vagina, the vaginal tablet can be moistened with a drop of clean water before insertion to ensure optimal treatment
Remnants of the tablet might be found on underwear due to non-dissolving excipients, this does not affect the efficacy of dequalinium chloride
Use a sanitary towel or panty liner during treatment; the tablet will not discolour the underwear
Insert vaginal tablet in a reclined position with the legs slightly bent

Not established for use in children below 18 years

Pregnancy

Recommendations below are applicable to South Africa and other jurisdictions

• Caution
• 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 to dequalinium chloride after vaginal administration
• Dequalinium chloride should only be used in pregnancy if clearly necessary

Breastfeeding

Recommendations below are applicable to South Africa and other jurisdictions

• Caution
• Systemic exposure of the breastfeeding women to dequalinium chloride is negligible. Therefore, no harmful effects on the breastfed newborn/infant are anticipated
• Dequalinium chloride can be used during lactation if clinically needed
• To minimise exposure of the newborn to dequalinium chloride, vaginal tablets should not be used within 12 hours before birth

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• No studies on effects on fertility have been conducted in animals

South African recommendations

• Caution; no information available

Recommendations in other jurisdictions

• Caution; no dose adjustment recommended
  No dose adjustment provided in professional information. Dose adjustment is unlikely due to limited systemic absorption

South African recommendations

• Caution; no information available

Recommendations in other jurisdictions

• Caution; no dose adjustment recommended
  No dose adjustment provided in professional information. Dose adjustment is unlikely due to limited systemic absorption

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; no dose adjustment recommended
  There is a lack of data on the efficacy and safety of dequalinium chloride in women above 55 years of age

Infections and infestations

• Vaginal candidiasis (Common)
• Bacterial vaginitis (Uncommon)
• Fungal skin infection (Uncommon)
• Vulvitis (Uncommon)
• Vulvovaginitis (Uncommon)
• Cystitis (Not known)

Nervous system disorders

• Headache (Uncommon)

Gastrointestinal disorders

• Nausea (Uncommon)

Reproductive system and breast disorders

• Vaginal discharge (Common)
• Vulvovaginal pruritus (Common)
• Vulvovaginal burning sensation (Common)
• Vaginal haemorrhage (Uncommon)
• Vaginal pain (Uncommon)
• Ulceration and maceration of vaginal epithelium (Not known)
• Uterine bleeding (Not known)
• Redness (Not known)
• Vaginal dryness (Not known)

General disorders and administration site conditions

• Allergic reactions with symptoms (Not known)
  - Urticaria (Not known)
  - Erythema (Not known)
  - Exanthema (Not known)
  - Swelling (Not known)
  - Rash (Not known)
  - Pruritus (Not known)
• Fever (Not known)

• Anionic substances
• Soaps
• Detergents
• Surfactants
• Spermicides
• Vaginal douches (vaginal washes)

Other interactions

• Non-latex condoms
• Intravaginal devices
• Diaphragms

None routine

Dequalinium chloride is a surface-active substance. The primary mechanism of action is an increase in bacterial cell permeability and the subsequent loss of enzyme activity, finally resulting in cell death. Dequalinium chloride exhibits a rapid bactericidal activity. Dequalinium chloride in vaginal tablets exerts its action locally within the vagina.

Spectrum of activity: Aerobic Gram-positive bacteria: Enterococcus faecalis, Lactobacillus spp., Staphylococcus aureus, Streptococcus agalactiae (Group B streptococci), Streptococcus pyogenes (Group A streptococci); Aerobic Gram-negative bacteria: Enterobacter spp., Escherichia coli, Klebsiella spp., Pseudomonas spp., Serratia spp.; Anaerobic bacteria: Atopobium vaginae, Bacteroides spp., Fusobacteria, Gardnerella vaginalis, Prevotella spp., Peptostreptococci, Poryphyromonas spp

Vaginal tablet 10mg

• Fluomizin (Adcock Ingram Limited) originator