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 USP is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness of Clobetasol Propionate Ointment USP in pediatric patients have not been established. Use in children 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’s 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’s 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 USP in geriatric patients is warranted.

ADVERSE REACTIONS:

In controlled clinical trials, the most frequent adverse events reported for Clobetasol Propionate Ointment USP 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’s 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 USP can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

Apply a thin layer of Clobetasol Propionate Ointment USP to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)

Clobetasol Propionate Ointment USP is a super-high potency topical corticosteroid; 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.

Clobetasol Propionate Ointment USP 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 supplied in 15-g (NDC 70700-106-15), 30-g (NDC 70700-106-16), 45-g (NDC 70700-106-18), and 60-g (NDC 70700-106-17) tubes.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature]. Do not refrigerate.

Distributed by:

Xiromed Logo
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XIROMED, LLC
Florham Park, NJ 07932 USA

Made in Spain

R02/2017
PI106-01

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL- 15 G CONTAINER

NDC 70700-106-15

Xiromed

CLOBETASOL

PROPIONATE

OINTMENT USP, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

NET WT 15 grams

PACKAGE LABEL ? PRINCIPAL DISPLAY PANEL ? 15 G CONTAINER
(click image for full-size original)

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL — 15 G CARTON

NDC 70700-106-15

Xiromed Rx only

CLOBETASOL PROPIONATE

OINTMENT USP, 0.05%

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

NET WT 15 grams

PACKAGE LABEL ? PRINCIPAL DISPLAY PANEL ? 15 G CARTON
(click image for full-size original)
CLOBETASOL PROPIONATE
clobetasol propionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-106
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-106-15 15 g in 1 TUBE None
2 NDC:70700-106-16 30 g in 1 TUBE None
3 NDC:70700-106-18 45 g in 1 TUBE None
4 NDC:70700-106-17 60 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209701 05/01/2018
Labeler — Xiromed, LLC (080228637)
Registrant — XIROMED PHARMA ESPANA, S.L. (468835741)
Establishment
Name Address ID/FEI Operations
Laboratorios Liconsa SAU 471409309 manufacture (70700-106)

Revised: 11/2020 Xiromed, LLC

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