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Name:Betamethasone Dipropionate
Manufacturer:E. Fougera & Co., A Division Of Nycomed Us Inc.
Category:Prescription Marketed Drugs


BETAMETHASONE DIPROPIONATEOINTMENT USP (AUGMENTED*), 0.05%

BETAMETHASONE DIPROPIONATE - betamethasone dipropionate ointment 
E. FOUGERA & CO., A division of Nycomed US Inc.

----------

BETAMETHASONE DIPROPIONATE
OINTMENT USP (AUGMENTED*), 0.05%

(Potency expressed as betamethasone)

* Vehicle augments the penetration of the steroid.

FOR DERMATOLOGICAL USE ONLY
NOT FOR OPHTHALMIC USE

Rx only

DESCRIPTION

Betamethasone dipropionate ointment (augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic 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-methyl-pregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

structural formula

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of betamethasone dipropionate ointment (augmented) contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in an augmented vehicle of propylene glycol, propylene glycol stearate, white wax and white petrolatum.

CLINICAL PHARMACOLOGY

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.

Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, anti-pruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

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. (See DOSAGE AND ADMINISTRATION section.)

Topical corticosteroids can be absorbed from 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 section.)

Once absorbed through the skin, topical corticosteroids enter 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.

At 14 g per day, betamethasone dipropionate ointment (augmented) was shown to depress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in patients with psoriasis. Adrenal depression in these patients was transient, and rapidly returned to normal upon cessation of treatment. At 7 g per day (3.5 g bid), betamethasone dipropionate ointment (augmented) was shown to cause minimal inhibition of the hypothalamic-pituitary-adrenal (HPA) axis when applied two times daily for 2 to 3 weeks, in normal patients and in patients with psoriasis and eczematous disorders.

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

INDICATIONS AND USAGE

Betamethasone dipropionate ointment (augmented), is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

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

PRECAUTIONS

General: Systemic absorption of topical corticosteroids has produced reversible 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 corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. (See DOSAGE AND ADMINISTRATION section.)

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:

  1. 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.
  2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive. (See DOSAGE AND ADMINISTRATION section.)
  4. Patients should report any signs of local adverse reactions.

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

 
Urinary free cortisol test
 
ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topically applied corticosteroids.

Studies to determine mutagenicity with prednisolone have revealed negative results.

Pregnancy: Teratogenic effectsPregnancy 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 of the teratogenic effects of topically applied corticosteroids in pregnant women. 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 prescribed for a nursing woman.

Pediatric Use: Use of betamethasone dipropionate ointment (augmented) in pediatric patients under 12 years is not recommended.

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 children 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 when topical corticosteroids are used as recommended. 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, miliaria.

The following adverse reactions have also been reported with betamethasone dipropionate ointment (augmented): erythema and vesiculation.

Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

DOSAGE AND ADMINISTRATION

Apply a thin film of betamethasone dipropionate ointment (augmented) to the affected skin areas once or twice daily. Treatment with betamethasone dipropionate ointment (augmented) should be limited to 45 g per week.

Betamethasone dipropionate ointment (augmented) is not to be used with occlusive dressings.

HOW SUPPLIED

Betamethasone Dipropionate Ointment USP (Augmented*), 0.05%, is supplied as follows:

NDC 0168-0268-15     15 gram tube NDC 0168-0268-50     50 gram tube

Store between 2° and 25°C (36° and 77°F).

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747
I268A
R1/08
#240

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

NDC 0168-0268-15

FOUGERA ®

BETAMETHASONE
DIPROPIONATE OINTMENT
USP (AUGMENTED
* ), 0.05%
(Potency expressed as betamethasone)
* Vehicle augments the penetration of the steroid.

Rx only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
Each gram contains: 0.64 mg
betamethasone dipropionate, USP
(equivalent to 0.5 mg betamethasone)
in an augmented vehicle of propylene
glycol, propylene glycol stearate,
white wax and white petrolatum.

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

NDC 0168-0268-15

FOUGERA ®              Rx only

BETAMETHASONE DIPROPIONATE
OINTMENT USP (AUGMENTED
* ), 0.05%
(Potency expressed as betamethasone)
* Vehicle augments the penetration of the steroid.

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

WARNING: Keep out of reach
of children.

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 G CONTAINER

NDC 0168-0268-50

FOUGERA ®

BETAMETHASONE
DIPROPIONATE OINTMENT
USP (AUGMENTED
* ), 0.05%
(Potency expressed as betamethasone)
* Vehicle augments the penetration of the steroid.

Rx only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
Each gram contains: 0.64 mg Betamethasone
dipropionate, USP (equivalent to 0.5 mg
betamethasone) in an augmented vehicle of
propylene glycol, propylene glycol stearate,
white wax and white petrolatum.

NET WT 50 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 G CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 G CARTON

NDC 0168-0268-50

FOUGERA ®              Rx only

BETAMETHASONE DIPROPIONATE
OINTMENT USP (AUGMENTED
* ), 0.05%
(Potency expressed as betamethasone)
* Vehicle augments the penetration of the steroid.

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

WARNING: Keep out of reach
of children.

NET WT 50 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 G CARTON

BETAMETHASONE DIPROPIONATE 
betamethasone dipropionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0268
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
betamethasone dipropionate (betamethasone dipropionate) betamethasone dipropionate 0.64 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Petrolatum  
White Wax  
Propylene Glycol Monostearate  
propylene glycol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0268-15 15 g in 1 TUBE None
2 NDC:0168-0268-50 50 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075373 10/14/2009

Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 174491316 ANALYSIS, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 043838424 ANALYSIS

Revised: 10/2009 E. FOUGERA & CO., A division of Nycomed US Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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