Document
DailyMed Label: BETAMETHASONE VALERATE
Title
DailyMed Label: BETAMETHASONE VALERATE
Date
2011
Document type
DailyMed Prescription
Name
BETAMETHASONE VALERATE
Generic name
BETAMETHASONE VALERATE
Manufacturer
STAT RX USA LLC
Product information
NDC: 16590-034
Product information
NDC: 16590-034
Description
Betamethasone Valerate Cream, Ointment and Lotion contain
betamethasone valerate USP, a synthetic adrenocortico-steroid for dermatologic
use. Betamethasone, an analog of prednisolone, has a high degree of
glucocorticoid activity and a slight degree of mineralocorticoid activity.
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:
Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate
(equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of
purified water, mineral oil, white petrolatum, polyethylene glycol 1000
monocetyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric
acid or sodium hydroxide; chlorocresol is present as a preservative.
Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate
(equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and
mineral oil.
Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate
(equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water
slightly thickened with carbomer 934P. Phosphoric acid or sodium hydroxide is
used to adjust pH.
Structure Image
Indications
Topical corticosteroids are indicated for the relief of the inflammatory and
pruritic manifestations of cortico-steroid-responsive dermatoses.
Dosage
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.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparation.
Precautions
General: Systemic absorption of topical
corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA)
axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and
glucosuria in some patients.
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.
Therefore, patients receiving a large dose of a potent topical steroid
applied to a large surface area should be evaluated periodically for evidence of
HPA axis suppression by using the urinary free cortisol and ACTH stimulation
tests. 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
steroid.
Recovery of HPA axis function is generally prompt and complete upon
discontinuation of the drug. Infrequently, signs and symptoms of steroid
withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids
and thus be more susceptible to systemic toxicity (See
PRECAUTIONS—Pediatric Use
).
If irritation develops, topical corticosteroids should be discontinued and
appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate
antifungal or antibacterial agent should be instituted. If a favorable response
does not occur promptly, the corticosteroid should be discontinued until the
infection has been adequately controlled.
Information for Patients: 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.
Laboratory tests: The following tests may
be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis and Impairment of
Fertility: Long-term animal studies have not been performed to evaluate
the carcinogenic potential or the effect on fertility of topical
corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have
revealed negative results.
Pregnancy:
Teratogenic Effects — Pregnancy
Category C. Corticosteroids are generally teratogenic in laboratory
animals when administered systemically at relatively low dosage levels. The more
potent corticosteroids have been shown to be teratogenic after dermal
application in laboratory animals. There are no adequate and well-controlled
studies in pregnant women on teratogenic effects from topically applied
corticosteroids. Therefore, topical corticosteroids should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus. Drugs of this class should not be used extensively on pregnant patients,
in large amounts, or for prolonged periods of time.
Nursing Mothers: It is not known whether
topical administration of corticosteroids could 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, caution should be exercised when topical corticosteroids are
administered to a nursing woman.
Pediatric Use: 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.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome,
and intracranial hypertension have been reported in children receiving topical
corticosteroids. Manifestations of adrenal suppression in children include
linear growth retardation, delayed weight gain, low plasma cortisol levels, and
absence of response to ACTH stimulation. Manifestations of intracranial
hypertension include bulging fontanelles, headaches, and bilateral
papilledema.
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.
Adverse reactions
The following local adverse reactions are reported infrequently
with topical corticosteroids, but may occur more frequently with the use of
occlusive dressings. These reactions are listed in an approximate decreasing
order of occurrence: burning, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis,
allergic contact dermatitis, maceration of the skin, secondary infection, skin
atrophy, striae and miliaria.
How supplied
Betamethasone Valerate
Betamethasone Valerate
Betamethasone Valerate
Cream USP, 0.1%
Ointment USP, 0.1%
Lotion USP, 0.1%
is supplied as follows:
is supplied as follows:
is supplied as follows:
15 g tubes NDC 0168-0040-15
15 g tubes NDC 0168-0033-15
60 mL bottles NDC 0168-0041-60
45 g tubes NDC 0168-0040-46
45 g tubes NDC 0168-0033-46
Shake well before using.
Store at controlled room temperature 15° - 30°C (59° - 86°F).
E. FOUGERA and CO. A division of Nycomed US Inc. Melville, NY
11747
I240D R12/07 #57
Clinical pharmacology
Topical corticosteroids share anti-inflammatory, anti-pruritic
and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is
unclear. Various laboratory methods, including vasoconstrictor assays, are used
to compare and predict potencies and/or clinical efficacies of the topical
corticosteroids. There is some evidence to suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic efficacy in
man.
Pharmacokinetics: The extent of
percutaneous absorption of topical corticosteroids is determined by many factors
including the vehicle, the integrity of the epidermal barrier, and the use of
occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation
and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of
topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic
adjunct for treatment of resistant dermatoses.
Once absorbed through the skin, topical corticosteroids are handled through
pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids
are metabolized primarily in the liver and are then excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into
the bile.
Package label
Rx only
Fougera ®
(Potency expressed as betamethasone) FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE
WARNING: Keep out of reach of children.
NET WT 45 grams
Label Image
1 organization
1 product
Product
Betamethasone ValerateOrganization
STAT RX USA LLC