Betamethasone dipropionate (topical)

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Betamethasone dipropionate (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Betamethasone dipropionate (topical) is an adrenal glucocorticoid and endocrine-metabolic agent that is FDA approved for the treatment of and relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Common adverse reactions include hypertension, atrophic condition of skin, folliculitis, pruritus of skin, stinging of skin, depression and euphoria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dosing Information
  • Apply a thin film of Betamethasone Dipropionate Cream, USP 0.05% (Augmented) to the affected skin areas once or twice daily. Treatment with betamethasone dipropionate cream, USP 0.05% (augmented) should be limited to 50 g per week.
  • Betamethasone Dipropionate Cream, USP 0.05% (Augmented) is not to be used with occlusive dressings.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Betamethasone dipropionate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Betamethasone dipropionate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Betamethasone dipropionate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Betamethasone dipropionate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Betamethasone dipropionate in pediatric patients.

Contraindications

  • Betamethasone Dipropionate Cream, USP 0.05% (Augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Warnings

PRECAUTIONS

  • General:
  • Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure.
  • Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 60 evaluable patients, of the 19 who showed evidence of suppression, 4 patients were tested 2 weeks after discontinuation of Betamethasone Dipropionate Cream, USP 0.05% (Augmented), and 3 of the 4 (75%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Adverse Reactions

Clinical Trials Experience

  • The only local adverse reaction reported to be possibly or probably related to treatment with Betamethasone Dipropionate Cream, USP 0.05% (Augmented) during adult controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.
  • Adverse reactions reported to be possibly or probably related to treatment with Betamethasone Dipropionate Cream, USP 0.05% (Augmented) during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months – 12 years of age.

|skin atrophy]], striae, miliaria.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Betamethasone dipropionate in the drug label.

Drug Interactions

There is limited information regarding Drug Interactions of Betamethasone dipropionate in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

Teratogenic effects=

  • Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 0.2- fold the maximum human dose based on a mg/m2 comparison. The abnormalities observed included umbilical hernias, cephalocele and cleft palates.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Betamethasone dipropionate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Betamethasone dipropionate during labor and delivery.

Nursing Mothers

  • It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

  • Use of Betamethasone Dipropionate Cream, USP 0.05% (Augmented) in pediatric patients 12 years of age and younger is not recommended.
  • In an open-label study, 19 of 60 (32%) evaluable pediatric patients (aged 3 months – 12 years old) using Betamethasone Dipropionate Cream, USP 0.05% (Augmented) for treatment of atopic dermatitis demonstrated HPA axis suppression. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group.
  • Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and [Cushing’s syndrome]] than mature patients because of a larger skin surface area to body weight ratio. The study described above supports this premise, as adrenal suppression in 9-12 year olds, 6-8 year olds, 2-5 year olds, and 3 months – 1 year old was 17%, 32%, 38%, and 50% respectively.

Geriatic Use

  • Clinical studies of Betamethasone Dipropionate Cream, USP 0.05% (Augmented) included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Gender

There is no FDA guidance on the use of Betamethasone dipropionate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Betamethasone dipropionate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Betamethasone dipropionate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Betamethasone dipropionate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Betamethasone dipropionate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Betamethasone dipropionate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical

Monitoring

There is limited information regarding IV Compatibility of Betamethasone dipropionate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Betamethasone dipropionate in the drug label.

Overdosage

  • Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

Pharmacology

Betamethasone dipropionate.png
Betamethasone dipropionate (topical)
Systematic (IUPAC) name
[(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-(2-propanoyloxyacetyl)-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate
Identifiers
CAS number 5593-20-4
ATC code ?
PubChem 21800
Chemical data
Formula C28H37FO7 
Mol. mass 504.59 g/mol
SMILES eMolecules & PubChem
Synonyms Betamethasone-17,21-dipropionate
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes topical

Mechanism of Action

Structure

  • Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:
This image is provided by the National Library of Medicine.

Pharmacodynamics

Laboratory Tests
  • The following tests may be helpful in evaluating HPA axis suppression:

Pharmacokinetics

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Betamethasone dipropionate in the drug label.

Clinical Studies

Carcinogenesis, Mutagenesis, Impairment of Fertility=

  • Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
  • Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the human dose based on a mg/m2 comparison, respectively.

How Supplied

Betamethasone Dipropionate Cream, USP 0.05% (Augmented) is supplied in:

NDC 0115-1472-52 15 g tubes

NDC 0115-1472-56 50 g tubes

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by: TOLMAR Inc., Fort Collins, CO 80526 Distributed by: Global Pharmaceuticals Division of IMPAX Laboratories, Inc. Philadelphia, PA 19124 44945 Rev. 0 07/12

Storage

  • Store between 2° and 30°C (36° and 86°F).

Images

Drug Images

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Package and Label Display Panel

Betamethasone dipropionate drug label01.png
This image of the FDA label is provided by the National Library of Medicine.
Betamethasone dipropionate drug label02.png
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Patient Counseling Information

  • Patients using topical corticosteroids should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
  • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.
  • Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
  • The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive.
  • Patients should report any signs of local adverse reactions.

Precautions with Alcohol

  • Alcohol-Betamethasone dipropionate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Celestone®

Look-Alike Drug Names

There is limited information regarding Betamethasone dipropionate (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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