Econazole

Pharmacologic Category

Antifungal Agent, Imidazole Derivative; Antifungal Agent, Topical

Dosing: Adult

Tinea pedis: Topical: Cream, Foam: Apply sufficient amount to cover affected areas once daily for 4 weeks

Tinea cruris, tinea corporis, tinea versicolor: Topical: Cream: Apply sufficient amount to cover affected areas once daily for 2 weeks

Cutaneous candidiasis: Topical: Cream: Apply sufficient quantity twice daily (morning and evening) for 2 weeks

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal 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: Pediatric

Candidiasis cutaneous (including diaper dermatitis): Limited data available: Infants, Children, and Adolescents: Topical: Cream: Apply sufficient amount to cover affected area twice daily (Bradley 2015; Kliegman 2015)

Tinea corporis, tinea cruris, and tinea versicolor (smaller lesions): Children and Adolescents: Limited data available: Topical: Cream: Apply sufficient amount to cover affected area once daily for 4 weeks (Bradley 2015)

Tinea pedis:

Cream: Children and Adolescents: Limited data available: Topical: Apply sufficient amount to cover affected area once daily for 4 weeks (Bradley 2015)

Foam: Children ≥12 years and Adolescents: Topical: Apply sufficient amount to cover affected area once daily for 4 weeks

Dosing: Renal 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.

Use: Labeled Indications

Fungal infection:

Cream: Treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

Foam: Treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years and older

* See Uses in AHFS Essentials for additional information.

Administration: Topical

For external use only. Not for oral, ophthalmic, or vaginal use. Avoid contact with the eyes.

Administration: Pediatric

Topical: For external use only. Not for oral, ophthalmic, or vaginal use. Avoid contact with the eyes. Shake foam canister for ~5 seconds before application.

Storage/Stability

Cream: Store below 30°C (86°F).

Foam: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Do not expose to heat and/or store at temperatures >49°C (120°F) even when the container is empty. Do not store in direct sunlight. Do not refrigerate or freeze.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat fungal infections of the skin.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Contraindications

Cream: Hypersensitivity to econazole or any component of the formulation

Foam: There are no contraindications listed in the manufacturer's labeling. Documentation of allergenic cross-reactivity for imidazole antifungals is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Irritation: Discontinue if sensitivity or irritation occurs.

Dosage form specific issues:

• Foam: Avoid heat, flame, and smoking during and immediately following application; topical foam is flammable.

Other warnings/precautions:

• Appropriate use: For topical use only; avoid contact with eyes, mouth, nose, or other mucous membranes

* See Cautions in AHFS Essentials for additional information.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Pregnancy Considerations

Information related to econazole use in pregnancy is primarily from use for other indications and route of administration. Until more data are available, it is suggested to avoid use in the first trimester and apply sparingly during the second and third trimesters if needed for topical fungal infections (Patel 2017).

Breast-Feeding Considerations

It is not known if econazole is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Briggs' Drugs in Pregnancy & Lactation

• Econazole

Adverse Reactions

1% to 10%: Dermatologic: Burning sensation of skin (3%), erythema (3%), pruritus (3%), stinging of the skin (3%)

<1%, postmarketing, and/or case reports: Application site reaction, pruritic rash

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Azole Antifungal Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Vitamin K Antagonists (eg, warfarin): Econazole may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Monitoring Parameters

Reassess diagnosis if no clinical improvement after completion of treatment course.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External, as nitrate:

Generic: 1% (15 g, 30 g, 85 g)

Foam, External, as nitrate:

Ecoza: 1% (70 g) [contains propylene glycol, trolamine (triethanolamine)]

Kit, External, as nitrate:

Econasil: 1% [contains benzoic acid]

Zolpak: 1% [contains benzoic acid]

Anatomic Therapeutic Chemical (ATC) Classification

• D01AC03
• G01AF05

Generic Available (US)

May be product dependent

Pricing: US

Cream (Econazole Nitrate External)

1% (per gram): $2.00 - $7.25

Foam (Ecoza External)

1% (per gram): $9.60

Kit (Econasil External)

1% (per each): $3,785.00

Kit (Zolpak External)

1% (per each): $3,485.00

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.

Mechanism of Action

Alters fungal cell wall membrane permeability; may interfere with RNA and protein synthesis, and lipid metabolism

Pharmacodynamics/Kinetics

Absorption: Cream: <10%

Metabolism: Cream: Hepatic to more than 20 metabolites

Time to peak: Foam: 6.8 ± 5.1 hours

Excretion: Cream: Urine (<1%); feces (<1%)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Econazole Nitrate; Spectazole

FDA Approval Date

December 23, 1982

References

American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Bradley JS, Nelson JD, Kimberlin DK, et al, eds. Nelson's Pediatric Antimicrobial Therapy. 20th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2014.

Econazole Nitrate Cream (econazole nitrate) [package insert]. Pine Brook, NJ: Alvogen, Inc; January 2020.

Ecoza (econazole nitrate) [package insert]. Jamison, PA: Quinnova Pharmaceuticals, LLC; December 2019.

Heel RC, Brogden RN, Speight TM, et al, "Econazole: A Review of Its Antifungal Activity and Therapeutic Efficacy," Drugs, 1978, 16(3):177-201.

Kliegman RM, Stanton BMD, St. Geme J, Schor NF, eds. Nelson' s Textbook of Pediatrics. 20th ed. Philadelphia, PA: Saunders Elsevier; 2015.

Patel VM, Schwartz RA, Lambert WC. Topical antiviral and antifungal medications in pregnancy: a review of safety profiles. J Eur Acad Dermatol Venereol. 2017;31(9):1440-1446. doi: 10.1111/jdv.14297.[PubMed 28449377]

Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259.[PubMed 19188870]

Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219.[PubMed 17555487 ]

Brand Names: International

Bismultin (GR); Conatrate (EG); Confort (CN); Derma-Coryl (CY, IQ, IR, LY, OM, SY, YE); Diconate (BD); Ecalin (HR, RU); Ecoderm (EG, ZA, ZW); Ecodermac (UY); Ecolet (BD); Ecomi (HK, VN); Econ (TH); Econaderm (BB, BM, BS, BZ, GY, JM, SR, TT); Econaz (LB); Ecoren (BD); Ecorex (JO, QA); Ecostatin (IE); Ecotam (ES); Ecozol-VT (HK); Ecu-Cure (JO); Epi-Pevaryl (DE); Fungazol (PK); Fungistop (ZW); Fungryl (EG); Gyno (EE); Gyno-Coryl (CY, IQ, IR, LY, OM, SY, YE); Gyno-Pevaryl (AE, BH, HU, IL, JO, KW, LB, LU, QA, SA); Italconazol (EC); Micolis (AR, CL, EC, PE, PY, UY); Miconax (VE); Micos (IT); Micostyl (BR); Micotex (AR); Myleugyn LP (FR); Penicomb (GR); Pevaryl (AE, AT, AU, BF, BG, BH, BJ, CH, CI, CY, CZ, DK, EE, EG, ET, FI, FR, GB, GH, GM, GN, GR, HN, HU, IE, IS, IT, JO, KE, LB, LK, LR, LU, MA, ML, MR, MT, MU, MW, MY, NE, NG, NL, NO, NZ, PH, PL, PT, QA, SA, SC, SD, SE, SK, SL, SN, TN, TR, TZ, UG, VE, VN, ZM, ZW); Pevaryl Lipogel (HU, MX); Pevaryl P.v. (HU); Phepix (TW); Polycain (JP); Stazol (TW); Syollone (KR); Tigna (CO); Zolecon (BD)

Last Updated 9/25/20