Carbol-Fuchsin (Topical)


VA CLASSIFICATION
Primary: DE102
Secondary: DE900

Commonly used brand name(s): Castellani Paint Modified (Color).

Another commonly used name is
Castellani Paint
{02}{03} Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Antifungal (topical)—

drying agent (topical)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Macerations (treatment adjunct);{21} or
Phenol nail procedures, postoperative (treatment)—Carbol-fuchsin (containing phenol 1.5%) is indicated for postoperative phenol nail procedures and as a first aid antiseptic drying agent. {21}

[Skin and nail infections, fungal, minor (treatment)]—Carbol-fuchsin (containing phenol 4.5%) is indicated in the topical treatment of minor fungal skin and nail infections {04}, including tinea pedis (ringworm of the foot; athlete's foot) caused by Trichophyton species or Epidermophyton floccosum and onychomycosis (tinea unguium; ringworm of the nails) caused by Trichophyton species, Epidermophyton floccosum , or Candida albicans . Carbol-fuchsin is indicated only during the acute and chronic stages of dermatophytoses. {14}

[Tinea pedis (treatment adjunct)]—Carbol-fuchsin is indicated as a topical drying agent in the adjunctive treatment of tinea pedis (ringworm of the foot; athlete's foot). {04}

[Tinea barbae (treatment)]; or
[Tinea capitis (treatment)]—Carbol-fuchsin is used in the topical treatment of tinea barbae and tinea capitis.

—Not all species or strains of a particular organism may be susceptible to carbol-fuchsin.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Phenol: 94.11 {06}
    Resorcinol: 110.11 {07}
    Acetone: 58.08 {08}
    Alcohol: 46.07 {09}

Mechanism of action/Effect:

Antifungal (topical)—Has fungicidal properties. The dye, basic fuchsin, has been reported to stimulate granulation and epithelialization. {14}


Other actions/effects:

Also has local anesthetic and bactericidal properties. {14}


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of carbol-fuchsin topical solution have not been performed in the pediatric population. However, when used in the treatment of infantile eczema, carbol-fuchsin topical solution should not be applied more than once daily. {14}


Geriatrics


No information is available on the relationship of age to the effects of carbol-fuchsin topical solution in geriatric patients.


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
    
Skin irritation not present before therapy{12}


Those indicating need for medical attention only if they continue or are bothersome
    
Mild, temporary stinging{13}




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Carbol-Fuchsin (Topical) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to carbol-fuchsin





Use in children—Not using on infants and children with eczema more than once a day {19}


Proper use of this medication
» Poison if swallowed; importance of using only on affected areas; not swallowing this medication; {14} not using near eyes; not using over large areas of the body; not using on deep wounds, puncture wounds, animal bites, or serious burns {21}

Before applying, washing affected areas with soap and water and drying thoroughly {14}

Applying a small amount with an applicator or swab; not bandaging the treated area {14} {21}

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

Precautions while using this medication
Checking with physician if no improvement within 1 week {14} or if condition becomes worse {21}

» Medication will stain skin {20} {21} and clothing {14} {21}; stain will slowly wear off from skin {20}


Side/adverse effects
Signs of potential side effects, especially skin irritation not present before therapy


General Dosing Information
Use of topical antifungals may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical use of the medication. {14}

Carbol-fuchsin topical solution should never be applied to large areas of the body {21}, because the high concentration of the constituents (basic fuchsin, phenol, resorcinol, acetone) in the hydroalcoholic solution may cause irritation. {14}


Topical Dosage Forms

Note: Bracketed information in the Dosage Forms section refers to uses that are not included in U.S. product labeling.

CARBOL-FUCHSIN TOPICAL SOLUTION USP

Usual adult and adolescent dose
[Antifungal] ; or
[Drying agent]
Topical, to the skin, one to three times a day. {14}


Usual pediatric dose
[Antifungal] ; or
[Drying agent]
See Usual adult and adolescent dose.


Note: For infantile eczema, topical carbol-fuchsin should be applied to the skin not more than once daily.


Strength(s) usually available
U.S.—
Not commercially available; compounding required.

Canada—
Not commercially available; compounding required.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F). Store in a tight, light-resistant container. Protect from freezing. {14}

Preparation of dosage form:
Prepare Carbol-Fuchsin Topical Solution USP, as follows:

• 3 grams Basic Fuchsin


• 45 grams Phenol


• 100 grams Resorcinol


• 50 mL Acetone


• 100 mL Alcohol


• Purified Water, a sufficient quantity, to make 1000 mL.
Dissolve the basic fuchsin in a mixture of the acetone and alcohol, and add to this solution the phenol and resorcinol that has been previously dissolved in 725 mL of purified water. Then add sufficient purified water to make the product measure 1000 mL, and mix. {22}

Auxiliary labeling:
   • Keep away from eyes.
   • Poison if swallowed.
   • For external use only.
   • Keep container tightly closed.
   • Continue medication for full time of treatment.
   • Will stain clothing and skin.


CARBOL-FUCHSIN TOPICAL SOLUTION, non-USP

Usual adult and adolescent dose
Drying agent; or {21}
Phenol nail procedures, postoperative {21}
Topical, to the skin, one to three times a day. {21}


Usual pediatric dose
Drying agent; or
Phenol nail procedures, postoperative
See Usual adult and adolescent dose.


Strength(s) usually available
U.S.—


1.5% phenol (OTC) [Castellani Paint Modified (Color){21} (water) (SD alcohol 40B) (resorcinol) (acetone) (basic fuchsin)]

Note: There is also a Castellani Paint Modified (Colorless) {21}, which does not contain basic fuchsin.


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F) {21}, unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Auxiliary labeling:
   • Keep away from eyes. {21}
   • Poison if swallowed.
   • For external use only. {21}
   • Keep container tightly closed.
   • Will stain clothing and skin. {21}



Revised: 06/15/1999



References
  1. Open.
  1. Redbook 1989: Castellani Paint (generic), Castel Minus (Syosset), Castel Plus (Syosset): 212; Red Book 1991: 183.
  1. Facts and Comparisons: Castellani Paint, Castel Minus, Castel Plus, Rev 4/86: 584.
  1. Package insert (US)—Castellani Paint (Pedinol): Rec 3/85. RB-91: 183.
  1. Open.
  1. USAN 1989: 430.
  1. USAN 1989: 483.
  1. USAN 1989: 19.
  1. USAN 1989: 26.
  1. Open.
  1. Open.
  1. U.S. Pharmacist. (Feb) 1985: 12.
  1. Cutis. (Oct) 1980; 26(4).
  1. AHFS 1988: 1990.
  1. USP XXI: 161.
  1. Open.
  1. Open.
  1. Open.
  1. Reviewer comment of 11/91.
  1. Reviewer comments of 11/91.
  1. Castellani Paint Modified (Color and Colorless) package insert (Pedinol, US), Rev 1/94, Rec 6/98.
  1. The United States pharmacopeia. The national formulary. USP 23rd revision (January 1, 1995). NF 18th ed. (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention Inc; 1994. p. 272.
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