Betamethasone valerate (topical)

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Betamethasone valerate (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 valerate (topical) is an adrenal glucocorticoidand endocrine-metabolic agent that is FDA approved for the treatment of the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Common adverse reactions include hypertension, skin atrophy, erythema, striae, folliculitis, vesicles in skin, 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 Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.
  • Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

PRECAUTIONS
  • General:
  • Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

(There is limited information regarding Postmarketing Experience of Betamethasone valerate in the drug label.)

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

TeratogenicEffects=


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

Pediatric Use

  • Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatic Use

There is no FDA guidance on the use of Betamethasone valerate with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Others

Administration and Monitoring

Administration

  • Topical

Monitoring

There is limited information regarding Monitoring of Betamethasone valerate in the drug label.

IV Compatibility

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

Overdosage

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

Pharmacology

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Betamethasone valerate (topical)
Systematic (IUPAC) name
(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro- 11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl- 6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro- 3H-cyclopenta[a]phenanthren-3-one
Identifiers
CAS number 378-44-9
ATC code A07EA04 C05AA05 (WHO) D07AC01 (WHO) H02AB01 (WHO) R01AD06 (WHO) R03BA04 (WHO) S01BA06 (WHO) S02BA07 (WHO) S03BA03 (WHO)
PubChem 9782
DrugBank DB00443
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 392.461
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Metabolism hepatic CYP3A4
Half life 36-54 hours
Excretion Renal (in urine)
Therapeutic considerations
Pregnancy cat.

C(US)

Legal status

Template:Unicode Prescription only

Routes Oral,Topical,IM

Mechanism of Action

Structure

  • Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

Nonclinical Toxicology

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

Clinical Studies

Carcinogenesis, Mutagenesis and Impairment of Fertility
  • Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

How Supplied

This image is provided by the National Library of Medicine.

E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, NY 11747

Storage

  • Store at room temperature 15° - 30°C (59° - 86°F).

Images

Drug Images

Package and Label Display Panel

Betamethasone valerate drug lable 01.png
This image of the FDA label is provided by the National Library of Medicine.
Betamethasone valerate drug lable 02.png
This image of the FDA label is provided by the National Library of Medicine.
Betamethasone valerate drug lable 03.png
This image of the FDA label is provided by the National Library of Medicine.
Betamethasone valerate drug lable 04.png
This image of the FDA label is provided by the National Library of Medicine.
Betamethasone valerate drug lable 05.png
This image of the FDA label is provided by the National Library of Medicine.
Betamethasone valerate drug lable 06.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

  • Patients using topical corticosteroids should receive the following information and instructions:
  • This medication is to be used as directed by the physician. 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 unless directed by the physician.
  • Patients should report any signs of local adverse reactions especially under occlusive dressing.
  • Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Precautions with Alcohol

Alcohol-Betamethasone valerate 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 valerate (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Drug Shortage

Price

References

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