CLOBETASOL PROPIONATE- clobetasol propionate cream

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

Buy It Now

Active ingredient:
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Clobetasol propionate cream is a super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. 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 the diagnosis may be necessary. Clobetasol Propionate Cream USP, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Product summary:
Clobetasol Propionate Cream, USP, 0.05% is supplied in 15-g tubes (NDC 68071-1599-1 ) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Clobetasol propionate cream should not be refrigerated. Rx only Manufactured by: Glenmark Pharmaceuticals Ltd. Village : Kishanpura, Baddi Nalagarh road District : Solan, Himachal Pradesh – 173205 India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1(888)721-7115 www.glenmarkpharma.com/usa August 2018
Authorization status:
Abbreviated New Drug Application
Authorization number:
68071-1599-1

CLOBETASOL PROPIONATE- clobetasol propionate cream

NuCare Pharmaceuticals,Inc.

----------

Clobetasol Propionate Cream USP, 0.05%

Rx only

FOR TOPICAL DERMATOLOGIC USE ONLY-

NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE

DESCRIPTION:

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

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

high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate USP is (11ß,16ß)-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 USP has the empirical formula C

CIFO

and a molecular weight of 467. It

is a white to cream-colored crystalline powder insoluble in water.

Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a cream base

of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate

and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax.

CLINICAL PHARMACOLOGY:

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 A

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

Pharmacokinetics :

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

including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone

for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of

hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed

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

percutaneous absorption.

Studies performed with clobetasol propionate cream indicate that they are in the super-high range of

potency as compared with other topical corticosteroids.

INDICATIONS AND USAGE:

Clobetasol propionate cream is a super-high potency corticosteroid formulations indicated for the

relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50

g/week because of the potential for the drug to suppress the hypothalamic-pituitary adrenal (HPA) axis.

Use in pediatric patients under 12 years of age is not recommended.

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 the diagnosis may be necessary.

CONTRAINDICATIONS:

Clobetasol Propionate Cream USP, 0.05% are contraindicated in those patients with a history of

hypersensitivity to any of the components of the preparations.

PRECAUTIONS:

General:

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

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

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

potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of

Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic

absorption of topical corticosteroids while on therapy.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be

evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH

stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving super-potent

corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be

treated at any one time due to the increased risk of HPA suppression.

Clobetasol propionate cream produced HPA axis suppression when used at doses as low as 2 g/day for

1 week in patients with eczema.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the

frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is

generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of

glucocorticosteroid insufficiency may occur that require supplemental systemic corticosteroids. For

information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their

larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

If irritation develops, clobetasol propionate cream should be discontinued and appropriate therapy

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

heal rather than noting a clinical exacerbation as with most topical products not containing

corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

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 cream

should be discontinued until the infection has been adequately controlled.

Information for Patients:

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact

with the eyes .

2. This medication should not be used for any disorder other than that for which it was prescribed.

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

unless directed by the physician.

4. Patients should report any signs of local adverse reactions to the physician.

Laboratory Tests:

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, Mutagenesis, Impairment of Fertility:

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

propionate.

Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg/day revealed

that the females exhibited an increase in the number of resorbed embryos and a decrease in the number

of living fetuses at the highest dose.

Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces

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

Pregnancy:

Teratogenic Effects:

Pregnancy Category C.

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 when applied topically; 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 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate cream.

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 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate

cream. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate

in pregnant women. Clobetasol propionate cream should be used during pregnancy only if the potential

benefit justifies the potential risk to the fetus.

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 cream is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness of clobetasol propionate cream 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’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

cream (n = 231) 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 cream in geriatric patients is warranted.

ADVERSE REACTIONS:

In controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate

cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions

were itching, skin atrophy, and cracking and fissuring of the skin.

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 cream can be absorbed in sufficient amounts to produce

systemic effects (see PRECAUTIONS ).

DOSAGE AND ADMINISTRATION:

Apply a thin layer of clobetasol propionate cream to the affected skin areas twice daily and rub in gently

and completely (see INDICATIONS AND USAGE).

Clobetasol propionate cream are super-high potency topical corticosteroids; therefore, treatment

should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be

us ed.

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 cream 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 cream, safety did not differ from that in younger patients; therefore, no

dosage adjustment is recommended.

HOW SUPPLIED:

Clobetasol Propionate Cream, USP, 0.05% is supplied in 15-g tubes (NDC 68071-1599-1 )

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP

Controlled Room Temperature].

Clobetasol propionate cream should not be refrigerated.

Rx only

Manufactured by:

Glenmark Pharmaceuticals Ltd.

Village : Kishanpura, Baddi Nalagarh road

District : Solan, Himachal Pradesh – 173205

India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1(888)721-7115

www.glenmarkpharma.com/usa

August 2018

Package/Label Display Panel

CLOBETASOL PROPIONATE

clobetasol propionate cream

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 0 71-159 9 (NDC:6 8 46 2-529 )

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

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

CHLO RO CRESO L (UNII: 36 W53O710 9 )

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

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

WATER (UNII: 0 59 QF0 KO0 R)

ANHYDRO US TRISO DIUM CITRATE (UNII: RS7A450 LGA)

WHITE WAX (UNII: 7G1J5DA9 7F)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-159 9 -1

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

0 7/23/20 19

NuCare Pharmaceuticals,Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 0 9 5

0 5/10 /20 18

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re la be l(6 8 0 71-159 9 )

Revised: 7/2019

Similar products

Search alerts related to this product

View documents history

Share this information