Candidiasis:
Oropharyngeal, mild disease (alternative agent) (off-label use): Topical solution (0.00165%): Apply to affected area twice daily; swish in the mouth and retain for as long as possible (several minutes) before expectorating. Duration is for 7 to 14 days (HHS [OI adult 2021]; Mukherjee 2017).
Topical infection: Topical: Apply to affected area 1 to 3 times daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Gentian violet: Pediatric drug information")
Oral candidiasis: Limited data available: Note: Not the preferred treatment; ulceration and/or burns of the oral mucosa have been reported in neonates and young infants in as little as 4 days (John 1968; Piatt 1992; Slotkowski 1966); use with caution and limit use.
Infants: Topical: Topical solution (0.5% or 1%): Apply sparingly to affected area (under tongue or on oral lesion) once or twice daily for ≤3 days (Faber 1927; John 1968; Piatt 1992; Slotkowski 1966).
Children and Adolescents: Topical: Topical solution (0.5% to 2%): Apply to affected area twice daily (Gal 2007).
Topical dermal infection: Infants, Children, and Adolescents: Topical: Topical Solution (1% or 2%): Apply to affected area 1 to 3 times daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Generic: 1% (59 mL); 2% (59 mL, 59.14 mL)
Yes
Topical: Clean the affected area prior to application. Apply directly to the wound or with a cotton applicator. Do not cover with bandage. Avoid contact with eyes.
Topical:
Dermal/skin: Clean the affected area prior to application. Apply directly to the wound or with cotton; do not apply to ulcerative lesions. Do not cover with bandage; keep affected area dry and exposed to air.
Oral candidiasis mouth lesions: Apply topically to affected areas in the mouth. For infants, apply sparingly after feedings.
Topical infection: Treatment of abrasions, minor cuts, surface injuries, and superficial infections of the skin.
Oropharyngeal candidiasis, mild disease
Gentian violet may be confused with gentamicin
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Central nervous system: Localized burning
Dermatologic: Allergic contact dermatitis, local skin necrosis, skin discoloration, skin vesicle
Gastrointestinal: Esophagitis, gastrointestinal irritation, mucous membrane ulceration
Genitourinary: Hemorrhagic cystitis
Hypersensitivity: Hypersensitivity reaction
Local: Local irritation, tissue necrosis at injection site
Ophthalmic: Keratoconjunctivitis
Respiratory: Epistaxis, laryngitis, tracheitis
OTC labeling: When used for self-medication, do not use in the eyes or on ulcerative lesions.
Concerns related to adverse effects:
• Staining: Use will result in staining of skin and clothing. Application to ulcerative lesions may result in tattooing.
Disease-related concerns:
• Cancer: Animal studies have concluded that there is a potential link to cancer following oral exposure of gentian violet; cases of cancer in humans have not been reported (Health Canada 2019).
Other warnings/precautions:
• Appropriate use: When used for self-medication (OTC use), patients should notify healthcare provider if redness, irritation, swelling, or pain persists or increases, or if infection occurs. For external use only; avoid contact with eyes.
Gentian Violet can cause ulceration of mucous membranes in neonates and young infants. Case reports in infants using 1% or 2% gentian violet suggest that application for as little as 4 days may lead to ulceration, which can be masked by the purple staining. Mechanism for ulceration is unclear; it may be related to alcohol content or direct irritating effect of gentian violet. Close monitoring is recommended; some experts suggest limiting the use of gentian violet to once or twice daily and only using for a short period of time (Leung 1988; Piatt 1992; Slotkowski 1957; Slotkowski 1966). Some products may contain alcohol (up to 10%); use caution when using on infants and children.
None known.
There are no known significant interactions.
Due to the potential for serious adverse reactions in the nursing infant, breast-feeding is not recommended; safer alternatives for topical skin infections are available (Stoukides, 1993).
Topical antiseptic/germicide effective against some vegetative gram-positive bacteria, particularly Staphylococcus sp, and some yeast; it is much less effective against gram-negative bacteria and is ineffective against acid-fast bacteria
Solution (Gentian Violet External)
1% (per mL): $0.14
2% (per mL): $0.27
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