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Gentian violet: Drug information

Gentian violet: Drug information
(For additional information see "Gentian violet: Patient drug information" and see "Gentian violet: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Antibiotic, Topical;
  • Antifungal Agent, Topical
Dosing: Adult
Candidiasis

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 infection: Topical: Apply to affected area 1 to 3 times daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Gentian violet: Pediatric drug information")

Oral candidiasis

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

Topical dermal infection: Infants, Children, and Adolescents: Topical: Topical Solution (1% or 2%): Apply to affected area 1 to 3 times daily.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

Postmarketing:

Dermatologic: Allergic contact dermatitis (Docampo 1990), skin necrosis (Docampo 1990)

Gastrointestinal: Mucous membrane abnormality (Docampo 1990)

Local: Local discomfort (Health Canada 2019), local pain (Health Canada 2019), local skin discoloration (Health Canada 2019)

Contraindications

OTC labeling: When used for self-medication, do not use in the eyes or on ulcerative lesions.

Warnings/Precautions

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.

Warnings: Additional Pediatric Considerations

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.

Dosage Forms: US

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)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Gentian Violet External)

1% (per mL): $0.14

2% (per mL): $0.27

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Administration: Pediatric

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.

Use: Labeled Indications

Topical infection: Treatment of abrasions, minor cuts, surface injuries, and superficial infections of the skin.

Use: Off-Label: Adult

Oropharyngeal candidiasis, mild disease

Medication Safety Issues
Sound-alike/look-alike issues:

Gentian violet may be confused with gentamicin

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Breastfeeding Considerations

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).

Mechanism of Action

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CN) China: Methylrosanilinum chloride
  1. Candidiasis (Mucocutaneous). In: US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Adult_OI.pdf. Updated May 26, 2020. Accessed June 16, 2021.
  2. Docampo R, Moreno SN. The metabolism and mode of action of gentian violet. Drug Metab Rev. 1990;22(2-3):161-178. doi:10.3109/03602539009041083 [PubMed 2272286]
  3. Faber HK, Clark EB. Prevention and treatment of thrush (oidial stomatitis). Am J Dis Child. 1927;34(3):408-417.
  4. Gal P, Reed M. Medications. In: Kliegman RM, Behrman RE, Jenson HB, et al, eds. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, PA: Saunders Elsevier; 2007: 2955-2999.
  5. Gentian violet 1% [prescribing information]. Texarkana, TX: Humco; October 2013.
  6. Gentian violet 2% [prescribing information]. Texarkana, TX: Humco; March 2019.
  7. Health Canada Advisory. Summary safety review - gentiane violet liquid topical (gentian violet) and hydrofera antibacterial foam dressings. https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00224. Published June 11, 2019. Accessed May 21, 2020.
  8. John RW. Necrosis of oral mucosa after local application of crystal violet. Br Med J. 1968;1(5585):157-158. [PubMed 20791427]
  9. Leung AK. Gentian violet in the treatment of oral candidiasis. Pediatr Infect Dis J. 1988;7(4):304-305. [PubMed 3368270]
  10. Mukherjee PK, Chen H, Patton LL, et al; Oral HIVAIDS Research Alliance (OHARA) AIDS Clinical Trials Group (ACTG) 5265 Team. Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants. AIDS. 2017;31(1):81-88. doi:10.1097/QAD.0000000000001286 [PubMed 27677161]
  11. Piatt JP, Bergeson PS. Gentian violet toxicity. Clin Pediatr (Phila). 1992;31(12):756-757. [PubMed 1451385]
  12. Slotkowski EL. Formation of mucous membrane lesions secondary to prolonged use of one per cent aqueous gentian violet. Journal of Pediatrics. 1957:652-654.
  13. Slotkowski EL, Redondo D. Mucosal irritation following use of gentian violet. JAMA. 1966:112;40-42.
  14. Stoukides C, "Topical Medications and Breastfeeding," J Hum Lact, 1993, 9(3):185-7. [PubMed 8260040]
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