Gentian violet is a topical violet triphenylmethane dye indicated for skin antisepsis to prevent skin infection in minor cuts, scrapes, or burns. Guidelines suggest gentian violet as an alternative to fluconazole for the treatment of initial episodes of oropharyngeal candidiasis in HIV-infected adults and adolescents. Gentian violet has antifungal and antibacterial properties. It is fungicidal against Candida species and is highly effective against gram-positive bacteria; it is less effective against gram-negative bacteria. Gentian violet will stain clothing and skin. Application of gentian violet to ulcerative lesions can result in tattooing of the skin and should be avoided.
Route-Specific Administration
Topical Administration
-Clean the affected area.
-Apply to the affected area using a cotton-tipped applicator.
-Gentian violet will stain clothing and skin. Do not apply to ulcerative lesions as this may result in tattooing of the skin.
-Avoid contact with the eyes.
-Do not cover with a bandage.
-Do not use for longer than 7 days unless otherwise directed.
-If skin irritation or sensitivity develops or increases or if the condition persists or gets worse, discontinue gentian violet use.
Gentian violet is a dye that will stain clothing and cause skin discoloration. Do not apply to ulcerative lesions as this may result in tattooing of the skin.
If skin irritation or sensitivity develops or increases or if the condition persists or gets worse, discontinue gentian violet use.
Gentian violet is for external use only. Do not use gentian violet in the eyes (ophthalmic administration).
Do not use gentian violet on large areas of the body or with an occlusive dressing. Do not apply gentian violet to ulcerative lesions as this may result in tattooing of the skin. In case of deep puncture wounds, animal bites, or serious burns, consult a health care professional.
Data in human pregnancy with gentian violet are limited. Of 40 mother-child pairs who were exposed to gentian violet in the first trimester of pregnancy, a relationship with gentian violet and malformations was suggested based on defects in 4 patients. There are no relevant animal data with gentian violet.
Gentian violet has been used to treat oral and nipple Candida infection during breast-feeding. Guidelines for treating Candida infection of the nipples state that a solution of less than 0.5% gentian violet can be used for no more than 7 days on the nipple; however, safer alternative therapies are available. Application of gentian violet 1% or 2% solution to the mouth or tongue in breast-fed infants has caused oral ulcerations, which may result in tattooing of the skin. In a case report, use of gentian violet 1% solution twice daily was interrupted after 1 day in a 2-week-old exclusively breast-fed infant due to perceived airway discomfort. When therapy was resumed after 2 days with gentian violet 1% 4 times daily, cough and difficulty feeding developed after 1 day, and the infant was hospitalized and required intubation.
This drug may also have activity against the following microorganisms: Candida sp., Escherichia coli, Klebsiella sp., Proteus sp., Pseudomonas sp., Staphylococcus aureus (MRSA), Staphylococcus aureus (MSSA), Streptococcus sp.
NOTE: Some organisms may not have been adequately studied during clinical trials; therefore, exclusion from this list does not necessarily negate the drug's activity against the organism.
For skin antisepsis to help protect against skin and skin structure infections in minor cuts, skin abrasion, or burns:
Topical dosage (2% solution):
Adults: Apply a small amount to the affected area(s) 1 to 3 times daily for up to 7 days.
For the treatment of oropharyngeal candidiasis (thrush)*:
Topical dosage (0.00165% solution):
Adults: Apply to the affected area(s) twice daily for 7 to 14 days as alternative therapy.
Adolescents: Apply to the affected area(s) twice daily for 7 to 14 days as alternative therapy.
Maximum Dosage Limits:
-Adults
3 applications/day (2% solution) topically.
-Geriatric
3 applications/day (2% solution) topically.
-Adolescents
Safety and efficacy have not been established; 2 applications/day (0.00165% solution) topically has been used off-label.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Gentian Violet products.
Gentian violet is a triphenylmethane dye with antibacterial and antifungal properties. It is fungicidal against Candida species and is highly effective against gram-positive bacteria; it is less effective against gram-negative bacteria and Mycobacterium likely due to its inability to penetrate the lipid surrounding the cell wall. The exact mechanism of action of gentian violet is unknown. Hypothesized mechanisms include altered redox potential, reduced nicotinamide adenine dinucleotide phosphate (NADPH) oxidase inhibition, free radical formation, unionized complex formation of bacteria with the dye, protein synthesis inhibition, glutamine synthesis inhibition, uncoupling of oxidative phosphorylation, bacterial cell wall formation inhibition, and biofilm disruption.
Gentian violet is applied topically. The pharmacokinetic parameters of gentian violet have not been evaluated.