Professional Drug Information > Ecostatin

Econazole (Topical)

VA CLASSIFICATION
Primary: DE102

Commonly used brand name(s): Ecostatin cream; Spectazole cream.

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



Category:


Antifungal (topical)^{12}{14}{15}—
Note: Econazole is a broad-spectrum antifungal ^{{12} {14} {15}}, which has an antifungal spectrum similar to that of miconazole.



Indications

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

Accepted

Candidiasis, cutaneous^{12}{14}{15} (treatment)—Econazole is indicated as a primary agent in the topical treatment of cutaneous candidiasis (moniliasis) caused by Candida (Monilia) species. ^{{05} {06} {09} {10} {14} {15}}

Tinea corporis^{12}{14}{15} (treatment)
Tinea cruris^{12}{14}{15} (treatment) or
Tinea pedis^{12}{14}{15} (treatment)—Econazole is indicated as a primary agent in the topical treatment of tinea corporis (ringworm of the body), tinea cruris (ringworm of the groin; jock itch), or tinea pedis (ringworm of the foot; athlete's foot) caused by Trichophyton rubrum , Trichophyton mentagrophytes , Trichophyton tonsurans , Microsporum canis , Microsporum audouini , Microsporum gypseum , and Epidermophyton floccosum (Acrothesium floccosum) . ^{{09} {12} {14} {15}}

Tinea versicolor^{12}{14}{15} (treatment)—Econazole is indicated as a primary agent in the topical treatment of tinea versicolor (pityriasis versicolor; ``sun fungus'') caused by Pityrosporon orbiculare (Malassezia furfur) . ^{{09} {12} {14} {15}}

[Paronychia (treatment)]¹—Econazole is used in the topical treatment of paronychia caused by fungi. ^{03}

[Tinea barbae (treatment)]¹ or
[Tinea capitis (treatment)]¹—Econazole is used in combination with griseofulvin or systemic ketoconazole (for griseofulvin-resistant cases) in the treatment of tinea barbae and tinea capitis. ^{03}

—Not all species or strains of a particular organism may be susceptible to econazole.

Unaccepted
Econazole is not indicated for moderate to severe paronychia or onychomycosis ^{15}.

¹ Not included in Canadian product labeling.

Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Chemical group—
    Synthetic chlorinated imidazole derivative ^{{09} {14}}, structurally related to clotrimazole, ketoconazole, and miconazole.
Molecular weight—
    Econazole nitrate: 444.7 ^{07}

Mechanism of action/Effect:

Fungistatic; may be fungicidal, depending on concentration; inhibits biosynthesis of ergosterol or other sterols, damaging the fungal cell wall membrane and altering its permeability ^{15}; as a result, loss of essential intracellular elements may occur; also inhibits biosynthesis of triglycerides and phospholipids by fungi; in addition, inhibits oxidative and peroxidative enzyme activity, resulting in intracellular buildup of toxic concentrations of hydrogen peroxide, which may contribute to deterioration of subcellular organelles and cellular necrosis. ^{08}

Absorption:

Minimal systemic absorption following topical application to normal skin. ^{{09} {12} {14}}

Stratum corneum concentration

Far exceeded minimum inhibitory concentrations (MICs) for dermatophytes ^{{09} {14}}; inhibitory concentrations found in epidermis and as deep as middle region of dermis. ^{{09} {14}}

Elimination:
    Renal and fecal; < 1% of applied dose recovered in urine and feces. ^{{09} {14}}


Precautions to Consider

Carcinogenicity

Long-term studies in animals have not been done. ^{{09} {14}}

Pregnancy/Reproduction
Fertility—
Studies in rats have shown that econazole given orally causes prolonged gestation. ^{{09} {14}} However, intravaginal administration of econazole nitrate in humans has not been shown to cause prolonged gestation or other adverse reproductive effects. ^{{09} {14}}

Pregnancy—
Adequate and well-controlled studies in humans have not been done.

Segment I studies in rats have shown that econazole is fetotoxic or embryotoxic when given orally in doses 10 to 40 times the usual human dermal dose ^{{09} {14}}. Similar effects were seen in mice, rabbits, and/or rats in Segment II or Segment III studies when econazole was given orally in doses 80 or 40 times the usual human dermal dose, respectively ^{{09} {14}}. However, no teratogenic effects were seen in mice, rabbits, or rats when econazole was given orally. ^{{09} {14}}

FDA Pregnancy Category C. ^{{09} {14}}

Breast-feeding

It is not known whether econazole is distributed into human breast milk ^{{09} {14}}. Caution should be exercised when econazole nitrate is administered to a nursing woman. ^{{09} {14}} Econazole and/or its metabolites are distributed into the milk of rats following oral administration and were found in the nursing pups ^{{09} {14}}. Also, in lactating rats given large oral doses of econazole (40 or 80 times the usual human dermal dose), a decrease in the postpartum viability of pups and survival to weaning was seen. ^{{09} {14}}

Pediatrics

Appropriate studies on the relationship of age to the effects of econazole have not been performed in the pediatric population. However, pediatrics-specific problems that would limit the usefulness of this medicine in children are not expected.


Geriatrics


Appropriate studies on the relationship of age to the effects of econazole have not been performed in the geriatric population. However, geriatrics-specific problems that would limit the usefulness of this medicine in the elderly are not expected.

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 problem exists
Sensitivity to econazole^{{09}{12}{14}{15}}


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 ^{02}
    
Burning, itching, stinging, redness^{14}{15} , or other signs of irritation not present before therapy

Incidence rare
    
Pruritic rash^{14} (skin rash with itching)





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

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

Before using this medication
»   Conditions affecting use, especially:

Pregnancy—Fetotoxic and embryotoxic reactions were seen in rats, mice, and rabbits given large oral doses ^{{09} {14}}





Breast-feeding—It is not known if econazole nitrate is distributed into human breast milk; however, econazole was distributed into breast milk of rats given large oral doses ^{{09} {14}}

Proper use of this medication
Applying sufficient medication to cover affected and surrounding areas ^{{09} {14}}, and massaging in gently ^{{12} {15}}

» Avoiding contact with the eyes

» Not applying occlusive dressing over this medication unless directed to do so by physician

» Compliance with full course of therapy; fungal infections may require prolonged therapy

» 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 2 weeks or more, or if condition becomes worse

» Using hygienic measures to help cure infection or to help prevent reinfection ^{02}

For tinea cruris
Avoiding underwear that is tight-fitting or made from synthetic materials; wearing loose-fitting cotton underwear instead

Using a bland, absorbent powder or an antifungal powder on the skin; not using cream and powder concurrently

For tinea pedis
Carefully drying feet, especially between toes, after bathing

Avoiding socks made from wool or synthetic materials; wearing clean, cotton socks and changing them daily or more often if feet perspire excessively

Wearing well-ventilated shoes or sandals

Using a bland, absorbent powder or an antifungal powder between toes, on feet, and in socks and shoes liberally once or twice daily; not using cream and powder concurrently


Side/adverse effects
Signs of potential side effects, especially burning, itching, stinging, redness, or other signs of irritation not present before therapy; or pruritic rash


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

To reduce the possibility of recurrence, Candida infections, tinea cruris, and tinea corporis should be treated for at least 2 weeks and tinea pedis should be treated for at least 1 month. ^{{09} {14}} (In Canada, the recommendations are 2 weeks of treatment for Candida infections and 1 month for dermatophyte infections. ^{15})

When this medication is used in the treatment of candidiasis, occlusive dressings should be avoided since they provide conditions that favor growth of yeast and release of its irritating endotoxin.


Topical Dosage Forms

ECONAZOLE NITRATE CREAM

Usual adult and adolescent dose
Candidiasis, cutaneous
Topical, to the affected and surrounding skin areas, two times a day, morning and evening for two weeks. ^{{09} {12} {14} {15}}

Tinea corporis; or
Tinea cruris; or
Tinea versicolor
Topical, to the affected and surrounding skin areas, one or two times a day for two to four weeks. ^{{14} {15}}

Tinea pedis
Topical, to the affected and surrounding skin areas, one or two times a day for four weeks. ^{{14} {15}}


Usual pediatric dose
See Usual adult and adolescent dose . ^{13}

Strength(s) usually available
U.S.—


1% (Rx) [Spectazole cream^{09}{14} (benzoic acid) (butylated hydroxyanisole) (mineral oil) (peglicol 5 oleate) (pegoxol 7 stearate) (purified water)]

Canada—


1% (Rx) [Ecostatin cream^{12}{15} (benzoic acid) (butylated hydroxyanisole) (fragrance) (mineral oil) (palm oil) (polyethylene glycol) (polyethylene glycol stearate) (water)]

Packaging and storage:
Store below 30 °C (86 °F) ^{{12} {14} {15}}, preferably between 15 and 25 °C (59 and 77 °F), ^{15} in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only ^{{12} {14} {15}}.
   • Continue medicine for full time of treatment.

Revised: 06/14/1999

References

1. Indications Index review, 1986.
   

2. Panel comments, Econazole (Topical), 11/13/86.
   

3. Panel comments, Econazole (Systemic), 8/22/88.
   

4. Open.
   

5. Open.
   

6. Open.
   

7. Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p. 263.
   

8. McEvoy GK, editor. AHFS Drug information 98. Bethesda, MD: American Society of Health-Systems Pharmacists Inc; 1998. p. 2880.
   

9. Spectazole cream package insert (Ortho-McNeil—US), Rev 3/94, Rec 12/95.
   

10. Open.
    

11. Open.
    

12. Ecostatin monograph (Westwood-Squibb—Canada), Rev 10/92, Rec 5/95.
    

13. Panel Ballot comments, sent 1/13/92, due 2/3/92, processed 2/14/92.
    

14. Spectazole (Ortho-McNeil). In: PDR Physicians' desk reference. 53rd ed. 1999. Montvale, NJ: Medical Economics Co Inc; 1999. p. 2179.
    

15. Ecostatin (Westwood-Squibb). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialities. 34rd ed. Ottawa: Canadian Pharmacists Association; 1999. p. 577.
    

Link to this page

Printable Version

Email Page