CLOBETASOL PROPIONATE emulsion

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

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Active ingredient:
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Available from:
Hi-Tech Pharmacal Co., Inc.
INN (International Name):
CLOBETASOL PROPIONATE
Composition:
CLOBETASOL PROPIONATE 0.5 mg in 1 g
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Clobetasol propionate emollient cream, 0.05% is a super-high potency corticosteroid indicated for: Clobetasol propionate emollient cream, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week. Clobetasol propionate emollient cream USP, 0.05% is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended. Clobetasol propionate emollient cream, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. The total dosage should not exceed 50 grams per week. Avoid use if skin atrophy is present at the treatment site. None Pregnancy Category C. There are no adequate and well-controlled st
Product summary:
Clobetasol Propionate Emollient Cream, 0.05% is supplied in 15-g tubes (NDC 50383-270-15), 30-g tubes (NDC 50383-270-30), and 60-g tubes (NDC 50383-270-60). Store between 15° and 30° C (59° and 86° F). Clobetasol propionate emollient cream, 0.05% should not be refrigerated .
Authorization status:
Abbreviated New Drug Application
Authorization number:
50383-270-15, 50383-270-30, 50383-270-60

CLOBETASOL PROPIONATE- clobetasol propionate emulsion

Hi-Tech Pharmacal Co., Inc.

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CLOBETASOL PROPIONATE EMOLLIENT

CREAM, 0.05% safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE

EMOLLIENT CREAM, 0.05%.

CLOBETASOL PROPIONATE EMOLLIENT CREAM, 0.05%, for topical use

Initial U.S. Approval: 1994

INDICATIONS AND USAGE

Clobetasol propionate emollient cream, 0.05% is a corticosteroid indicated for: (1)

DOSAGE AND ADMINISTRATION

DOSAGE FORMS AND STRENGTHS

Cream: 0.05% (3) (3)

CONTRAINDICATIONS

None (4) (4)

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reaction is burning/stinging (incidence 5%); common adverse reactions (incidence < 2%) are

pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow,

skin atrophy, and telangiectasia. (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA

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

Revised: 5/2018

The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12

years of age or older. (1.1)

The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. (1.2)

Limitations of Use

Clobetasol propionate emollient cream, 0.05% should not be used in the treatment of rosacea or perioral dermatitis,

and should not be used on the face, groin, or axillae. (1.3)

The total dosage should not exceed 50 grams per week. (1.3)

Avoid use if skin atrophy is present at the treatment site. (1.3)

Apply a thin layer of clobetasol propionate emollient cream, 0.05% to the affected skin areas twice daily and rub in

gently and completely. (2)

Treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be

used. (2)

In moderate to severe plaque-type psoriasis, clobetasol propionate emollient cream, 0.05% applied to 5% to 10% of

body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When

dosing for more than 2 weeks, any additional benefit of extending treatment should be weighed against the risk of

HPA suppression. (2)

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis doses as

low as 2 grams per day. (5.1)

Cushing’s syndrome, hyperglycemia, and glucosuria can also result from systemic absorption of topical

corticosteroids. (5.1)

Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression

develops. (5.1)

Children may be more susceptible to systemic toxicity from use of topical corticosteroids. (5.1, 8.4)

Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings

and higher potency corticosteroids, including clobetasol propionate. These reactions include: folliculitis, acneiform

eruptions, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection,

striae and miliaria. (5.2)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Corticosteroid-Responsive Dermatoses

1.2 Moderate to Severe Plaque-Type Psoriasis

1.3 Limitations of Use

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Effects on the Endocrine System

5.2 Local Adverse Reactions with Topical Corticosteroids

5.3 Allergic Contact Dermatitis

5.4 Concomitant Skin Infections

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Clobetasol propionate emollient cream, 0.05% is a super-high potency corticosteroid indicated for:

1.1 Corticosteroid-Responsive Dermatoses

Clobetasol propionate emollient cream, 0.05% is indicated for the relief of the inflammatory and

pruritic manifestations of cortico-steroid-responsive dermatoses in patients 12 years of age and older.

Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams

per week.

1.2 Moderate to Severe Plaque-Type Psoriasis

Clobetasol propionate emollient cream USP, 0.05% is indicated for the topical treatment of moderate to

Sections or subsections omitted from the full prescribing information are not listed.

severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in

pediatric patients under 16 years of age is not recommended.

1.3 Limitations of Use

Clobetasol propionate emollient cream, 0.05% should not be used in the treatment of rosacea or

perioral dermatitis, and should not be used on the face, groin, or axillae.

The total dosage should not exceed 50 grams per week.

Avoid use if skin atrophy is present at the treatment site.

2 DOSAGE AND ADMINISTRATION

Apply a thin layer of clobetasol propionate emollient cream, 0.05% to the affected skin areas twice

daily and rub in gently and completely. Wash hands after each application.

Clobetasol propionate emollient cream, 0.05% is a super-high potency topical corticosteroid;

therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50

grams per week should not be used.

In moderate to severe plaque-type psoriasis, clobetasol propionate emollient cream, 0.05% applied to

5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50

grams per week. When dosing for more than 2 weeks, any additional benefits of extending treatment

should be weighed against the risk of HPA suppression. Therapy should be discontinued when control

has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be

necessary. Treatment beyond 4 consecutive weeks is not recommended.

Clobetasol propionate emollient cream, 0.05% should not be used with occlusive dressings.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.05%. Each gram of clobetasol propionate emollient cream, 0.05% contains 0.5 mg of

clobetasol propionate in a smooth, white cream base.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 Effects on the Endocrine System

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the

HPA axis at doses as low as 2 grams per day.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the

potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon

withdrawal of the topical corticosteroid.

Because of the potential for systemic absorption, use of topical corticosteroids may require that

patients be periodically evaluated for HPA axis suppression. In a study including 12 subjects ages 18

years and older with psoriasis or atopic dermatitis involving at least 30% body surface area (BSA),

adrenal suppression was identified in 3 out of 12 subjects (25%) following 1 week of treatment.

Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use

of more potent steroids, use over large surface areas, use over prolonged periods, use under

occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis

suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the

frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency

may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt

and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from

systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic

corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see

Use in Specific Populations (8.4)]

5.2 Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of

higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching,

irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, hypertrichosis, perioral

dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions

may be irreversible. Clobetasol propionate is not recommended in patients with acne vulgaris, rosacea

or perioral dermatitis.

5.3 Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal

rather than noting a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be

confirmed with patch testing. If irritation develops, clobetasol propionate emollient cream, 0.05%

should be discontinued and appropriate therapy instituted.

5.4 Concomitant Skin Infections

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent

should be used. If a favorable response does not occur promptly, use of clobetasol propionate

emollient cream, 0.05% should be discontinued until the infection has been adequately controlled.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug

and may not reflect the rates observed in clinical practice.

In controlled trials with clobetasol propionate formulations, the following adverse reactions have been

reported: burning/stinging, pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin,

numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia. The incidence of

local adverse reactions reported in the trials with clobetasol propionate emollient cream, 0.05% was

less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated

patients.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women. Therefore, clobetasol

propionate emollient cream, 0.05% should be used during pregnancy only if the potential benefit

justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered

systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic

after dermal application to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity by this route; however, it is absorbed

percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit

and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose

tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are

approximately 0.33 and 0.01 times, respectively, the human topical dose of clobetasol propionate

emollient cream, 0.05%. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are

approximately 0.001 and 0.003 times, respectively, the human topical dose of clobetasol propionate

emollient cream, 0.05%. Abnormalities seen included cleft palate, cranioschisis, and other skeletal

abnormalities.

8.3 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 emollient cream, 0.05% is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of clobetasol propionate emollient cream, 0.05% in pediatric patients have not

been established and its use in pediatric patients under 12 years of age is not recommended. In a study

including 12 subjects ages18 years and older with psoriasis or atopic dermatitis involving at least 30%

body surface area (BSA), adrenal suppression was identified in 3 out of 12 subjects (25%) following 1

week of treatment. Four-week HPA axis suppression studies with clobetasol propionate emollient

cream, 0.05% in pediatric subjects have not been conducted.

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 glucocorticosteroid 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 absence of

response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles,

headaches, and bilateral papilledema.

The use of clobetasol propionate emollient cream, 0.05% for 4 consecutive weeks has not been studied

in pediatric patients under 16 years of age.

8.5 Geriatric Use

Clinical studies of clobetasol propionate emollient cream, 0.05% did not include sufficient numbers of

subjects aged 65 and older to determine whether they respond differently from younger subjects. In

general, dose selection for an elderly patient should be cautious.

10 OVERDOSAGE

Topically applied clobetasol propionate emollient cream, 0.05% can be absorbed in sufficient amounts

to produce systemic effects [see Warnings and Precautions (5.1)].

11 DESCRIPTION

Clobetasol Propionate Emollient Cream, 0.05% contains the active compound clobetasol propionate, a

synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of

glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-

oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:

Clobetasol propionate has the molecular formula C

H ClFO and a molecular weight of 467. It is a

white to cream colored crystalline powder insoluble in water.

Each gram of Clobetasol Propionate Emollient Cream, 0.05% contains clobetasol propionate 0.5 mg/g

in an emollient base of cetomacrogol 1000, cetostearyl alcohol, citric acid, dimethicone 360, imidurea

as a preservative, isopropyl myristate, propylene glycol, purified water, and sodium citrate.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and

vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in

general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2

inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the

biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting

the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane

phospholipids by phospholipase A .

12.2 Pharmacodynamics

Clobetasol propionate emollient cream, 0.05% is in the super-high range of potency as demonstrated in

a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids.

However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors,

including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be

absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase

percutaneous absorption.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol

propionate.

Mutagenesis

Clobetasol propionate was nonmutagenic in three different test systems: the Ames test, the

Saccharomyces cerevisiae gene conversion assay, and the E. Coli B WP2 fluctuation test.

Impairment of Fertility

Studies in the rat following oral administration at dosage levels up to 50 mg/kg per day revealed no

significant effect on the males. The females exhibited an increase in the number of resorbed embryos

and a decrease in the number of living fetuses at the highest dose.

14 CLINICAL STUDIES

In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, clobetasol

propionate emollient cream, 0.05% was applied to 5% to 10% of body surface area. In this trial, there

were no clobetasol-treated patients with clinically significant decreases in morning cortisol levels after

4 weeks of treatment; however, morning cortisol levels may not identify patients with adrenal

dysfunction.

16 HOW SUPPLIED/STORAGE AND HANDLING

Clobetasol Propionate Emollient Cream, 0.05% is supplied in 15-g tubes (NDC 50383-270-15), 30-g

tubes (NDC 50383-270-30), and 60-g tubes (NDC 50383-270-60).

Store between 15° and 30° C (59° and 86° F).

Clobetasol propionate emollient cream, 0.05% should not be refrigerated.

17 PATIENT COUNSELING INFORMATION

Inform patients using topical corticosteroids of the following information and instructions:

Clobetasol propionate emollient cream, 0.05% is for external use only. Avoid contact with the

eyes.

Use as directed. Do not use clobetasol propionate emollient cream, 0.05% for any disorder other

than that for which it was prescribed. Do not use longer than the prescribed time period.

Do not use other corticosteroid-containing products while using clobetasol propionate emollient

cream, 0.05% unless directed by the physician.

The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be

occlusive unless directed by the physician.

Wash hands after applying the medication.

Report any signs of local or systemic adverse reactions to the physician.

Inform their physicians that they are using clobetasol propionate emollient cream, 0.05% if

surgery is contemplated. If you go to another doctor for illness, injury or surgery, tell the doctor

you are using clobetasol propionate emollient cream, 0.05%.

Do not use clobetasol propionate emollient cream, 0.05% on the face, underarms or groin areas.

Rx Only

Rev. 270:03 03/15

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Package/Label Display Panel

NDC 50383-270-60

AKORN

Clobetasol Propionate Emollient Cream, 0.05%

For dermatologic use only.

Not for ophthalmic use.

Rx only

60 grams

As with other corticosteroids, therapy should be discontinued when control is achieved. If no

improvement is seen within 2 weeks, contact the physician.

Use no more than 50 grams per week of clobetasol propionate emollient cream, 0.05%.

Store between 59°F and 86° (15°C and 30°C). Do not refrigerate.

CLOBETASOL PROPIONATE

clobetasol propionate emulsion

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:50 38 3-270

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CLO BETASO L PRO PIO NATE (UNII: 779 6 19 577M) (CLOBETASOL -

UNII:ADN79 D536 H)

CLOBETASOL

PROPIONATE

0 .5 mg

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CETETH-2 0 (UNII: I8 35H2IHHX)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

DIMETHICO NE 3 50 (UNII: 2Y53S6 ATLU)

IMIDUREA (UNII: M6 29 8 0 7ATL)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

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

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 38 3-270 -15

1 in 1 CARTON

0 6 /0 7/20 10

1

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

2

NDC:50 38 3-270 -30

1 in 1 CAPSULE

0 6 /0 7/20 10

2

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

3

NDC:50 38 3-270 -6 0

1 in 1 CARTON

0 6 /0 7/20 10

3

6 0 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 75325

0 6 /0 7/20 10

Labeler -

Hi-T ech Pharmacal Co., Inc. (101196749)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hi-Tech Pharmacal Co., Inc.

Hi-Tech Pharmacal Co ., Inc.

10 119 6 749

MANUFACTURE(50 38 3-270 ) , ANALYSIS(50 38 3-270 ) , PACK(50 38 3-270 )

Revised: 6/2020

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