Econazole Nitrate by Padagis Israel Pharmaceuticals Ltd ECONAZOLE NITRATE cream

Econazole Nitrate by

Drug Labeling and Warnings

Econazole Nitrate by is a Prescription medication manufactured, distributed, or labeled by Padagis Israel Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Topical Use Only

Not for Ophthalmic Use

Rx Only

DESCRIPTION

Econazole Nitrate Cream, 1% contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol-7 stearate, and purified water. The white to off-white soft cream is for topical use only.

Chemically, econazole nitrate is 1-[2-{(4-chlorophenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows:

CLINICAL PHARMACOLOGY

After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes. Inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis. Less than 1% of the applied dose was recovered in the urine and feces.

Microbiology -

Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Dermatophytes		Yeasts
Epidermophyton floccosum	Trichophyton mentagrophytes	Candida albicans
Microsporum audouini	Trichophyton rubrum	Malassezia furfur
Microsporum canis	Trichophyton tonsurans
Microsporum gypseum

Econazole nitrate exhibits broad-spectrum antifungal activity against the following organisms in vitro, but the clinical significance of these data is unknown.

• Dermatophytes:

  Yeasts

• Trichophyton verrucosum:

  Candida guillermondii

INDICATIONS AND USAGE

Econazole Nitrate Cream, 1% is indicated for topical application in the 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.

CONTRAINDICATIONS

Econazole Nitrate Cream, 1% is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

WARNINGS

Econazole Nitrate Cream, 1% is not for ophthalmic use.

PRECAUTIONS

General -

If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. For external use only. Avoid introduction of Econazole Nitrate Cream, 1% into the eyes.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Long-term animal studies to determine carcinogenic potential have not been performed.

Fertility (Reproduction) -

Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation. Intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C -

Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose. Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed.

Nursing Mothers -

It is not known whether econazole nitrate is excreted in human milk. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. Also, in lactating rats receiving large oral doses (40 or 80 times the human dermal dose), there was a reduction in post partum viability of pups and survival to weaning; however, at these high doses, maternal toxicity was present and may have been a contributing factor. Caution should be exercised when econazole nitrate is administered to a nursing woman.

ADVERSE REACTIONS

During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of pruritic rash has also been reported.

OVERDOSAGE

Overdosage of econazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and >160 mg/kg, respectively.

DOSAGE AND ADMINISTRATION

Sufficient Econazole Nitrate Cream, 1% should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis.

Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

HOW SUPPLIED

Econazole Nitrate Cream, 1% is available as follows:

15 g tube (NDC 45802-466-35)

30 g tube (NDC 45802-466-11)

85 g tube (NDC 45802-466-53)

STORAGE

Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature].

Manufactured By Perrigo

Bronx, NY 10457

Distributed By Perrigo

Allegan, MI 49010 www.perrigo.com

Rev. 05-15

: 2F300 RC JX1

Principal Display Panel

Rx Only

Econazole Nitrate Cream, 1%

For Topical Use Only. Not For Ophthalmic Use.

NET WT 15 g

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

INGREDIENTS AND APPEARANCE

ECONAZOLE NITRATE 
econazole nitrate cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 45802-466
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M)	ECONAZOLE NITRATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
PEG-5 OLEATE (UNII: 0240V77G50)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45802-466-35	1 in 1 CARTON	12/21/2006
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 45802-466-11	1 in 1 CARTON	11/10/2006
2		30 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 45802-466-53	1 in 1 CARTON	08/08/2006
3		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076479	08/08/2006

Labeler - Perrigo New York Inc (078846912)