NDC 51672-1317 Betamethasone Dipropionate
Ointment, Augmented Topical

Product Information

Betamethasone Dipropionate is a human prescription drug product labeled by Taro Pharmaceuticals U.s.a., Inc.. The product's dosage form is ointment, augmented and is administered via topical form.

Product Code51672-1317
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Betamethasone Dipropionate
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Betamethasone Dipropionate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormOintment, Augmented - An ointment dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented".
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Taro Pharmaceuticals U.s.a., Inc.
Labeler Code51672
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ANDA076753
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-12-2004
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Betamethasone Dipropionate?


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC 51672-1317-1

Package Description: 1 TUBE in 1 CARTON > 15 g in 1 TUBE

Price per Unit: $2.96951 per GM

NDC 51672-1317-3

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE

Price per Unit: $1.82050 per GM

NDC 51672-1317-5

Package Description: 5 g in 1 TUBE

Product Details

What are Betamethasone Dipropionate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Betamethasone Dipropionate Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 848180 - betamethasone dipropionate 0.05 % Augmented Topical Ointment
  • RxCUI: 848180 - Augmented betamethasone 0.0005 MG/MG Topical Ointment
  • RxCUI: 848180 - augmented betamethasone 0.05 % Topical Ointment
  • RxCUI: 848180 - betamethasone 0.05 % Augmented Topical Ointment
  • RxCUI: 848180 - betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical Ointment

Betamethasone Dipropionate Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Betamethasone Topical

Betamethasone Topical is pronounced as (bay ta meth' a sone)

Why is betamethasone topical medication prescribed?
Betamethasone is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions.This medication is sometimes pres...
[Read More]

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Betamethasone Dipropionate Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



1 Indications And Usage



Betamethasone dipropionate ointment (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.


2 Dosage And Administration



Apply a thin film of betamethasone dipropionate ointment (augmented) to the affected skin areas once or twice daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Betamethasone dipropionate ointment (augmented) is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate ointment (augmented) should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Betamethasone dipropionate ointment (augmented) should not be used with occlusive dressings unless directed by a physician.

Betamethasone dipropionate ointment (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.


3 Dosage Forms And Strengths



Ointment, 0.05%. Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white to off-white ointment base.


4 Contraindications



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


5.1 Effects On Endocrine System



Betamethasone dipropionate ointment (augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a trial evaluating the effects of betamethasone dipropionate ointment (augmented) on the HPA axis, at 14 g per day, betamethasone dipropionate ointment (augmented) was shown to suppress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in subjects with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 g per day, betamethasone dipropionate ointment (augmented) was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy subjects and in subjects with psoriasis and eczematous disorders.

With 6 g to 7 g of betamethasone dipropionate ointment (augmented) applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in subjects with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].


5.2 Allergic Contact Dermatitis



Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.


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 clinical trials, adverse reactions associated with the use of betamethasone dipropionate ointment (augmented) reported at a frequency of less than 1% included erythema, folliculitis, pruritus, and vesiculation.


6.2 Postmarketing Experience



Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, striae, and miliaria.

Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.


Teratogenic Effects



Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Betamethasone dipropionate ointment (augmented) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.


8.3 Nursing Mothers



Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can 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 betamethasone dipropionate ointment (augmented) is administered to a nursing woman.


8.4 Pediatric Use



Use of betamethasone dipropionate ointment (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [see Warnings and Precautions (5.1)].

In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream USP (augmented), 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of betamethasone dipropionate ointment (augmented) in the treatment of diaper dermatitis.


8.5 Geriatric Use



Clinical trials of betamethasone dipropionate ointment (augmented) included 225 subjects who were 65 years of age and over and 46 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.


11 Description



Betamethasone dipropionate ointment USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.

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:

It is a white to creamy white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an optimized vehicle of propylene glycol, propylene glycol stearate, white petrolatum, and white wax.


12.1 Mechanism Of Action



Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate ointment (augmented) in corticosteroid responsive dermatoses is unknown.


12.3 Pharmacokinetics



No pharmacokinetics trials have been conducted with betamethasone dipropionate ointment (augmented).

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 [see Dosage and Administration (2)].

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see Dosage and Administration (2)].

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.


13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility



Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli ), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.


14 Clinical Studies



The safety and efficacy of betamethasone dipropionate ointment (augmented) for the treatment of corticosteroid-responsive dermatoses, psoriasis and atopic dermatitis, have been evaluated in three randomized active-controlled trials, two in psoriasis and one in atopic dermatitis. A total of 378 subjects, of whom 152 received betamethasone dipropionate ointment (augmented), were included in these trials. These trials evaluated betamethasone dipropionate ointment (augmented) applied twice daily, for 14 days. Betamethasone dipropionate ointment (augmented) was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis.


16 How Supplied/Storage And Handling



Betamethasone Dipropionate Ointment USP (Augmented), 0.05% is a white ointment supplied in 15 g (NDC 51672-1317-1) and 50 g (NDC 51672-1317-3) tubes; boxes of one; and in a 5 g physician sample (tube only). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from freezing.


17 Patient Counseling Information



Inform patients of the following:

  • Discontinue therapy when control is achieved, unless directed otherwise by the physician.
  • Use no more than 50 grams per week of betamethasone dipropionate ointment (augmented) and no longer than 2 consecutive weeks.
  • Avoid contact with the eyes.
  • Avoid use of betamethasone dipropionate ointment (augmented) on the face, underarms, or groin areas unless directed by the physician.
  • Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
  • Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.

Other



Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Revised: August 2015
LPK-4528-4     72

0815-4 72


Principal Display Panel - 50 G Tube Carton



NDC 51672-1317-3

50 g

Betamethasone Dipropionate
Ointment (Augmented*) USP, 0.05%

(Potency expressed as betamethasone) *Vehicle augments the penetration of the steroid.

FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

TARO

Keep this and all medications out of the reach of children.


* Please review the disclaimer below.