Clobetasol Propionate (Page 2 of 2)

Nursing Mothers:

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate ointment is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness of clobetasol propionate ointment in pediatric patients have not been established. Use in pediatric patients under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use:

A limited number of patients at or above 65 years of age have been treated with clobetasol propionate ointment (n = 101) in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of clobetasol propionate ointment in geriatric patients is warranted.

ADVERSE REACTIONS

In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.

Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

OVERDOSAGE

Topically applied clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

Clobetasol propionate ointment is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetaol propionate ointment should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

Clobetasol propionate ointment USP, 0.05% is a white to off white ointment and supplied in:

15-g tubes (NDC 40032-096-60)

30-g tubes (NDC 40032-096-61)

60-g tubes (NDC 40032-096-62)

Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured By:

Novel Laboratories, Inc.

Somerset, NJ 08873

PI0960000102

Rev. 05/2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 g – Container Label

15 g -- Container
(click image for full-size original)

60 g – Carton Label

60 g -- Carton
(click image for full-size original)
CLOBETASOL PROPIONATE
clobetasol propionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-096
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
SORBITAN SESQUIOLEATE
PETROLATUM
Product Characteristics
Color WHITE (off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-096-60 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (40032-096-60)
2 NDC:40032-096-61 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (40032-096-61)
3 NDC:40032-096-62 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (40032-096-62)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208841 11/25/2016
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 ANALYSIS (40032-096), MANUFACTURE (40032-096)

Revised: 05/2016 Novel Laboratories, Inc.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.