KETOCONAZOLE- ketoconazole shampoo, suspension

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

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Active ingredient:
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)
Available from:
THIRTY MADISON INC
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ). Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. Ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
Product summary:
Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 71713-097-04). Storage conditions: Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS contact Thirty Madison, Inc. at 1-833-745-3377 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Thirty Madison, Inc. New York, NY 10016 04006149 Rev. 0 05/19
Authorization status:
Abbreviated New Drug Application
Authorization number:
71713-097-04

KETOCONAZOLE- ketoconazole shampoo, suspension

THIRTY MADISON INC

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Ketoconazole Shampoo

DESCRIPTION

Ketoconazole Shampoo, 2%

For Topical application only.

Rx only

Ketoconazole shampoo, 2%, is a red-orange liquid for topical application, containing the broad

spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It

also contains: sodium laureth sulfate, disodium laureth sulfosuccinate, cocamide diethanolamide,

hydrochloric acid, PEG-120 methyl glucose dioleate, imidurea, sodium chloride, sodium hydroxide,

fragrance, FD&C red No. 40, and purified water.

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

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

CLINICAL PHARMACOLOGY

Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum orbiculare

(Malassezia furfur). This commensal organism is part of the normal skin flora. In susceptible individuals

the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the

trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not

immediately result in restoration of pigment to the affected sites. Normalization of pigment following

successful therapy is variable and may take months, depending on individual skin type and incidental skin

exposure. The rate of recurrence of infection is variable.

Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6

months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months).

An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five

consecutive days showed that the irritancy potential of ketoconazole shampoo, 2%, was significantly

less than that of 2.5% selenium sulfide shampoo.

A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22

female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity

and no photoallergenic potential due to ketoconazole shampoo, 2%.

Mode of Action: Interpretations of in vivo studies suggest that ketoconazole impairs the synthesis of

ergosterol, which is a vital component of fungal cell membranes. It is postulated, but not proven, that the

therapeutic effect of ketoconazole in tinea (pityriasis) versicolor is due to the reduction of

Pityrosporum orbiculare (Malassezia furfur) and that the therapeutic effect in dandruff is due to the

reduction of Pityrosporum ovale. Support for the therapeutic effect in tinea versicolor comes from a

three-arm, parallel, double-blind, placebo controlled study in patients who had moderately severe tinea

(pityriasis) versicolor. Successful response rates in the primary efficacy population for each of both

three-day and single-day regimens of ketoconazole shampoo, 2%, were statistically significantly

greater (73% and 69%, respectively) than a placebo regimen (5%). There had been mycological

confirmation of fungal disease in all cases at baseline. Mycological clearing rates were 84% and 78%,

respectively, for the three-day and one-day regimens of the 2% shampoo and 11% in the placebo

regimen. While the differences in the rates of successful response between either of the two active

treatments and placebo were statistically significant, the difference between the two active regimens

was not.

Microbiology: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the 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, C. tropicalis, Pityrosporum ovale

(Malassezia ovale) and Pityrosporum orbiculare (M. furfur). Development of resistance by these

microorganisms to ketoconazole has not been reported.

INDICATIONS AND USAGE

Ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or

presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the

trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not

immediately result in normalization of pigment to the affected sites. Normalization of pigment following

successful therapy is variable and may take months, depending on individual skin type and incidental sun

exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes

the disease is part of the normal skin flora.

CONTRAINDICATIONS

Ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active

ingredient or excipients of this formulation.

PRECAUTIONS

Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use

of ketoconazole shampoo, 2%. If a reaction suggesting sensitivity or chemical irritation should occur,

use of the medication should be discontinued.

Information for Patients

Patients should be advised of the following:

Ketoconazole shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this

area should be avoided.

The following have been reported with the use of ketoconazole shampoo, 2%: hair discoloration

and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning

sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin

irritation, dry skin, and application site reactions.

Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling,

angioedema, or shortness of breath should discontinue ketoconazole shampoo, 2% and contact their

physician immediately.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to assess the carcinogenic potential of ketoconazole shampoo, 2% have not been

conducted. A long-term feeding study of ketoconazole 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 were not genotoxic. The Ames Salmonella

microsomal activator assay was also negative.

Pregnancy

Teratogenic effects: Pregnancy Category C:

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. In humans,

ketoconazole is not detected in plasma after chronic shampooing on the scalp.

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

orally in the diet at 80 mg/kg/day (a dose 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.

Nursing Mothers

There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in

plasma after chronic shampooing on the scalp. Caution should be exercised when ketoconazole

shampoo, 2%, is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

ADVERSE REACTIONS

Clinical Trials Experience

In 11 double-blind trials in 264 patients using ketoconazole shampoo, 2%, for the treatment of dandruff

or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of

patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six

months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules,

mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp

have been reported. In a double-blind, placebo-controlled trial in which patients with tinea versicolor

were treated with either a single application of ketoconazole shampoo, 2%, (n=106), a daily application

for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5

(5%), 7 (7%) and 4 (4%) of patients, respectively. The only events that occurred in more than one patient

in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of

these events occurred in more than 3% of the patients in any one of the three groups.

Post-marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not possible

to reliably estimate their frequency. The following adverse drug reactions have been identified during

post-marketing experience with ketoconazole shampoo, 2%: there have been reports of hair

discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis,

hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site

reactions.

OVERDOSAGE

Ketoconazole shampoo, 2%, is intended for external use only. In the event of accidental ingestion,

supportive and symptomatic measures should be employed. Induced emesis and gastric lavage should

not be performed to avoid aspiration.

DOSAGE AND ADMINISTRATION

Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area.

Lather, leave in place for 5 minutes, and then rinse off with water.

One application of the shampoo should be sufficient.

HOW SUPPLIED

Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic

bottle (NDC 71713-097-04).

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

from light.

To report SUSPECTED ADVERSE REACTIONS contact Thirty Madison, Inc. at 1-833-745-

3377 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by: Tolmar, Inc.

Fort Collins, CO 80526

Distributed by: Thirty Madison, Inc.

New York, NY 10016

04006149 Rev. 0 05/19

PRINCIPAL DISPLAY PANEL

KETOCONAZOLE

ketoconazole shampoo, suspension

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:71713-0 9 7

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 .5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

DISO DIUM LAURETH SULFO SUCCINATE (UNII: D6 DH1DTN7E)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

IMIDUREA (UNII: M6 29 8 0 7ATL)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

CO CO DIETHANO LAMIDE (UNII: 9 20 0 5F9 72D)

PEG-12 0 METHYL GLUCO SE DIO LEATE (UNII: YM0 K6 4F20 V)

WATER (UNII: 0 59 QF0 KO0 R)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

THIRTY MADISON INC

Product Characteristics

Color

RED (o range)

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:71713-0 9 7-

118 .28 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/11/20 0 5

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 9 42

0 4/11/20 0 5

Labeler -

T HIRT Y MADISON INC (080774087)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

TOLMAR Inc.

79 1156 578

ANALYSIS(71713-0 9 7) , LABEL(71713-0 9 7) , MANUFACTURE(71713-0 9 7) , PACK(71713-0 9 7)

Revised: 8/2019

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