KETOCONAZOLE cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)
Available from:
REMEDYREPACK INC.
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis. Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Product summary:
Ketoconazole cream, 2% is supplied in NDC: 70518-0762-00 1 in 1 CARTON, 15g in 1 TUBE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
70518-0762-0

KETOCONAZOLE- ketoconazole cream

REMEDYREPACK INC.

----------

Ketoconazole

Cream, 2%

Rx only

DESCRIPTION

Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%,

formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol,

isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan

monostearate and stearyl alcohol.

Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H-imidazol-1-ylmethyl)-1,3-dioxolan-

4-yl]methoxy]phenyl] piperazine and has the following structural formula:

Molecular Formula: C

Molecular Weight: 531.43

CLINICAL PHARMACOLOGY

When ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28

consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method

having a lower detection limit of 2 ng/mL.

After a single topical application to the chest, back and arms of normal volunteers, systemic absorption

of ketoconazole was not detected at the 5 ng/mL level in blood over a 72-hour period.

Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study

conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed

hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to

ketoconazole cream, 2%.

Microbiology

Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the

following common dermatophytes and yeasts by altering the permeability of the cell membrane:

dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini,

M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum

ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur

(Pityrosporum orbiculare). Only those organisms listed in the INDICATIONS AND USAGE section

have been proven to be clinically affected. Development of resistance to ketoconazole has not been

reported.

Mode of Action

In vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital

component of fungal cell membranes. It is postulated that the therapeutic effect of ketoconazole in

seborrheic dermatitis is due to the reduction of M. ovale, but this has not been proven.

INDICATIONS AND USAGE

Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea

pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment

of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of

cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

CONTRAINDICATIONS

Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or

excipient ingredients of this formulation.

WARNINGS

Ketoconazole cream, 2% is not for ophthalmic use.

PRECAUTIONS

General

If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be

discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and

ACTH induced corticosteroid serum levels have been seen with orally administered ketoconazole;

these effects have not been seen with topical ketoconazole.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic

activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of

ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The

Ames' salmonella microsomal activator assay was also negative.

Pregnancy

Teratogenic effects

Pregnancy Category C

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given

orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However,

these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used

during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Ketoconazole cream, 2% administered topically could result in sufficient

systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be

made whether to discontinue nursing or discontinue the drug, taking into account the importance of the

drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established.

ADVERSE REACTIONS

During clinical trials 45 (5.0%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of

208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus

and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction.

In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with

ketoconazole cream or one of its excipients, namely propylene glycol.

DOSAGE AND ADMINISTRATION

Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor

It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and

immediate surrounding area. 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 in order to

reduce the possibility of recurrence.

Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require

six weeks of treatment.

Seborrheic dermatitis

Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until

clinical clearing.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be

redetermined.

HOW SUPPLIED

Ketoconazole cream, 2% is supplied in

NDC: 70518-0762-00 1 in 1 CARTON, 15g in 1 TUBE

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Revised: March, 2014

PK-2925-4

354.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Ketoconazole

GENERIC: Ketoconazole

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0762-0

COLOR: white

PACKAGING: 15 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

Ketoconazole 20mg in 1g

INACTIVE INGREDIENT(S):

butylated hydroxyanisole

water

propylene glycol

sorbitan monostearate

polysorbate 80

cetyl alcohol

isopropyl myristate

polysorbate 60

stearyl alcohol

KETOCONAZOLE

ketoconazole cream

Product Information

Product T ype

HUMAN PRESCRIPTION

DRUG

Ite m Code

(S ource )

NDC:70 518 -0 76 2(NDC:516 72-129 8 )

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

KETO CO NAZO LE (UNII: R9 40 0 W9 27I) (KETOCONAZOLE - UNII:R9 40 0 W9 27I)

KETOCONAZOLE

20 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

REMEDYREPACK INC.

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

Product Characteristics

Color

white (White to o ff-white)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 518 -0 76 2-0

1 in 1 CARTON

10 /0 6 /20 17

1

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 756 38

10 /0 6 /20 17

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 5/2020

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