Nitrofurazone (Topical)


VA CLASSIFICATION
Primary: DE101

Commonly used brand name(s): Furacin Soluble Dressing; Furacin Topical Cream; Furacin Topical Solution.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial (topical)—{01}{02}{03}

Indications

General considerations
Nitrofurazone is bactericidal for most pathogens that commonly cause surface skin infections, including Staphylococcus aureus, Streptococcus, Escherichia coli, Clostridium perfringens, Enterobacter aerogenes, and Proteus organisms. {01} {02} {03}

Accepted

Burns (treatment)—Topical nitrofurazone is indicated as an adjunctive therapy for second and third degree burns when resistance to other agents is a real or potential problem. {01} {02} {03}

Skin infections (treatment)—Nitrofurazone is indicated in skin grafting when bacterial contamination may cause graft rejection or donor site infection, especially in hospitals with a history of resistant bacteria. {01} {02} {03}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    198.14 {03}

Mechanism of action/Effect:

The exact mechanism of action is unknown. Nitrofurazone inhibits several bacterial enzymes, especially those involved in the aerobic and anaerobic degradation of glucose and pyruvate. {01} {02} {03} This activity is believed also to affect pyruvate dehydrogenase, citrate synthetase, malate dehydrogenase, glutathione reductase, and pyruvate decarboxylase. {01} {02} {03}


Precautions to Consider

Cross-sensitivity and/or related problems

Use of nitrofurazone may allow overgrowth of nonsusceptible organisms including fungi {02} {03} and Pseudomonas . Treatment should be discontinued if overgrowth occurs. {01} {02} {03}

Carcinogenicity/Tumorigenicity

Nitrofurazone given orally in high doses to female rats can cause mammary tumors. {01} {02} {03} The relevance of this finding to topical use of nitrofurazone in humans is unknown. {01} {02} {03}

Pregnancy/Reproduction

Pregnancy—
Adequate and well-controlled studies in humans have not been done. {01} {02} {03} In rabbits, nitrofurazone given in oral doses thirty times the usual recommended human dose has been shown to produce embryocidal effects. {01} {02} {03}

FDA Pregnancy Category C. {01} {02} {03}

Breast-feeding

It is not known whether nitrofurazone is distributed into breast milk. {01} {02} {03} Problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of nitrofurazone have not been performed in the pediatric population. Safety and efficacy have not been established. {01} {02} {03}


Geriatrics


No information is available on the relationship of age to the effects of nitrofurazone in geriatric patients. However, elderly patients are more likely to have age-related renal function impairment, which may require adjustment of dosage in patients receiving nitrofurazone.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Renal function impairment{02}{03}    (polyethylene glycols in the base of the topical solution and the soluble dressing may be absorbed through denuded skin and may not be excreted normally, which may lead to increased blood urea nitrogen (BUN), anion gap, and metabolic acidosis {02} {03})


Sensitivity to nitrofurazone or other components of the formulation{01}{02}{03}


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
Incidence less frequent
    
Contact dermatitis {01}{02}{03}(itching; rash; swelling)





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient Nitrofurazone (Topical) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance)

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to nitrofurazone {01} {02} {03}
Other medical problems, especially renal function impairment for topical solution and soluble dressing dosage forms {02} {03}

Proper use of this medication
Applying sufficient medication to affected area {03} or placing medication on gauze to cover affected area {01} {02}

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

» Proper storage

Precautions while using this medication
The use of nitrofurazone occasionally allows overgrowth of nonsusceptible organisms including fungi {02} {03} and Pseudomonas . {01} {02} {03} If this occurs, or if irritation, sensitization, or superinfection develops, treatment should be discontinued {01} {02} {03}


Side/adverse effects
Signs of potential side effects, especially contact dermatitis {01} {02} {03}


General Dosing Information
Nitrofurazone should be applied directly to affected area {03} or on gauze to cover affected area. {01} {02}

The drug should be reapplied once daily or every few days, depending on the usual dressing technique.


Topical Dosage Forms

NITROFURAZONE CREAM

Usual adult and adolescent dose
Burns or
Skin infections
Topical, directly to lesion or place on gauze, once daily or every few days, depending on the usual dressing technique. {01}


Usual pediatric dose
Safety and efficacy have not been established. {01}

Strength(s) usually available
U.S.—


0.2% (Rx) [Furacin Topical Cream (cetyl alcohol) (ethoxylated fatty alcohol) (glycerin) (methylparaben) (mineral oil) (propylparaben) (purified water){01}]

Packaging and storage:
Nitrofurazone should be stored in a well-closed container. It should be protected from direct sunlight, strong fluorescent lighting, alkaline materials, and excessive heat (more than 40 °C [104 °F]). {01}

Auxiliary labeling:
   • For external use only. {01}
   • Keep out of reach of children.
   • Protect from light. {01}


NITROFURAZONE SOLUBLE DRESSING

Usual adult and adolescent dose
Burns or
Skin infections
Topical, directly to lesion or place on gauze, depending on the usual dressing technique. {02}


Usual pediatric dose
Safety and efficacy have not been established. {02}

Strength(s) usually available
U.S.—


0.2% (Rx) [Furacin Soluble Dressing (polyethylene glycol 300) (polyethylene glycol 900) (polyethylene glycol 3350){02}]

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

Preparation of dosage form:
Preparation of impregnated gauze

Place sterile gauze on a tray and cover with nitrofurazone soluble dressing, repeating this procedure until several layers of gauze have been added. Add a small amount of sterile water to each layer to prevent color change during autoclaving. Cover the tray loosely and autoclave at 121 °C for 30 minutes at 15 to 20 pounds of pressure. {02}

Preparation of bandage rolls

Place nitrofurazone soluble dressing in the bottom of a glass container. Stand bandage rolls on their ends inside the glass container. Add more nitrofurazone soluble dressing to the top of bandage rolls. Cover the container with aluminum foil and autoclave at 121 °C for 45 minutes at 15 to 20 pounds of pressure. Do not store impregnated rolls for more than 24 hours. {02}

Do not autoclave more than once. {02}

Auxiliary labeling:
   • For external use only. {02}
   • Keep out of reach of children.
   • Protect from light.


NITROFURAZONE TOPICAL SOLUTION

Usual adult and adolescent dose
Burns
Apply directly to affected area. {03}


Usual pediatric dose
Safety and efficacy have not been established. {03}

Strength(s) usually available
U.S.—


0.2% (Rx) [Furacin Topical Solution (octoxynol 9) (polyethylene glycol 400) (polyethylene glycol 4000) (purified water){03}]

Packaging and storage:
Keep away from excessive heat, sunlight, and alkaline materials. {03}

Auxiliary labeling:
   • For external use only. {03}
   • Keep out of reach of children. {03}
   • Protect from light.



Developed: 05/04/1999



References
  1. Furacin Topical Cream package insert (Roberts—US), Rev 3/97, Rec 7/98.
  1. Furacin Soluble Dressing package insert (Roberts—US), Rev 8/96, Rec 7/98.
  1. Furacin Topical Solution package insert (Roberts—US), Rev 11/91, Rec 7/98.
Hide
(web2)