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


BETAMETHASONE DIPROPIONATE CREAM USP, 0.05%BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%

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

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BETAMETHASONE DIPROPIONATE CREAM USP, 0.05%
BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%
BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%

(Potency expressed as betamethasone)

Rx only

For Dermatologic Use Only
Not for Ophthalmic Use

DESCRIPTION

Betamethasone Dipropionate Cream, Ointment and Lotion contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is:

Structural Formula

Each gram of the 0.05% Cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 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 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.

Each gram of the 0.05% Lotion contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol and purified water slightly thickened with carbomer 934P. Phosphoric acid or sodium hydroxide is used to adjust pH.

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 (See DOSAGE AND ADMINISTRATION).

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.

INDICATIONS AND USAGE

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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 (See DOSAGE AND ADMINISTRATION).

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 institute.

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. 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.
  4. Patients should report any signs of local adverse reactions.
  5. 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 (See DOSAGE AND ADMINISTRATION).

Laboratory tests: The following tests may be helpful in evaluating 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 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 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 when Betamethasone Dipropionate products are used as recommended in the DOSAGE AND ADMINISTRATION section. 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 infections, skin atrophy, striae and miliaria.

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.

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 Cream or Ointment to the affected skin areas once daily. In some cases, twice daily dosage may be necessary.

Apply a few drops of Betamethasone Dipropionate Lotion to the affected skin areas and massage lightly until it disappears. Apply twice daily, in the morning and at night.

If an infection develops, appropriate antimicrobial therapy should be instituted.

Betamethasone Dipropionate products should not be used with occlusive dressings.

HOW SUPPLIED

Betamethasone Dipropionate Betamethasone Dipropionate Betamethasone Dipropionate
Cream USP, 0.05% Ointment USP, 0.05% Lotion USP, 0.05%
is supplied as follows: is supplied as follows: is supplied as follows:
15 g tubes NDC 0168-0055-15 15 g tubes NDC 0168-0056-15 60 mL bottles NDC 0168-0057-60
45 g tubes NDC 0168-0055-46 45 g tubes NDC 0168-0056-46 Shake well before using.

Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing.

E. FOUGERA & CO.
A division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

I255H
R1/08
#74

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CONTAINER

NDC 0168-0055-15

Fougera

BETAMETHASONE
DIPROPIONATE
CREAM USP, 0.05%
(Potency expressed as betamethasone)

Rx only

Each gram contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 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.

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CARTON

NDC 0168-0055-15

Rx only

Fougera

BETAMETHASONE DIPROPIONATE
CREAM USP, 0.05%
(Potency expressed as betamethasone)

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 GRAM CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CONTAINER

NDC 0168-0055-46

Fougera

BETAMETHASONE
DIPROPIONATE
CREAM USP, 0.05%
(Potency expressed as betamethasone)

Rx only

Each gram contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 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.

NET WT 45 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON

NDC 0168-0055-46

Rx only

Fougera

BETAMETHASONE DIPROPIONATE
CREAM USP, 0.05%
(Potency expressed as betamethasone)

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

WARNING: Keep out of reach of children.

NET WT 45 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CONTAINER

NDC 0168-0056-15

Fougera

BETAMETHASONE
DIPROPIONATE
OINTMENT USP, 0.05%
(Potency expressed as betamethasone)

Rx only

Each gram contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CARTON

NDC 0168-0056-15

Rx only

Fougera

BETAMETHASONE DIPROPIONATE
OINTMENT USP, 0.05%
(Potency expressed as betamethasone)

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

Store at 25°C, excursions
permitted between 15°C and 30°C.
Protect from light and freezing.

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 GRAM CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CONTAINER

NDC 0168-0056-46

Fougera

BETAMETHASONE
DIPROPIONATE
OINTMENT USP, 0.05%
(Potency expressed as betamethasone)

Rx only

Each gram contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.

NET WT 45 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON

NDC 0168-0056-46

Rx only

Fougera

BETAMETHASONE DIPROPIONATE
OINTMENT USP, 0.05%
(Potency expressed as betamethasone)

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

WARNING: Keep out of reach of children.

NET WT 45 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML LABEL

NDC 0168-0057-60

Fougera

BETAMETHASONE
DIPROPIONATE
LOTION USP, 0.05%
(Potency expressed as betamethasone)

60 mL

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

Rx only

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML LABEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML CARTON

NDC 0168-0057-60

Fougera

BETAMETHASONE
DIPROPIONATE
LOTION USP, 0.05%
(Potency expressed as betamethasone)

60 mL

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

Each gram contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol and purified water slightly thickened with carbomer 934P. Phosphoric acid or sodium hydroxide are used to adjust pH.

Rx only

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML CARTON

BETAMETHASONE DIPROPIONATE 
betamethasone dipropionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0055
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
betamethasone dipropionate (betamethasone) betamethasone dipropionate 0.64 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
chlorocresol  
ceteth-20  
cetostearyl alcohol  
petrolatum  
sodium phosphate, monobasic, monohydrate  
mineral oil  
water  
phosphoric acid  
sodium hydroxide  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0055-15 15 g in 1 TUBE None
2 NDC:0168-0055-46 45 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA019137 02/26/1984

BETAMETHASONE DIPROPIONATE 
betamethasone dipropionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0056
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
betamethasone dipropionate (betamethasone) betamethasone dipropionate 0.64 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
mineral oil  
petrolatum  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0056-15 15 g in 1 TUBE None
2 NDC:0168-0056-46 45 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA019141 09/04/1984

BETAMETHASONE DIPROPIONATE 
betamethasone dipropionate lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0057
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
betamethasone dipropionate (betamethasone) betamethasone dipropionate 0.60 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
isopropyl alcohol  
water  
sodium hydroxide  
phosphoric acid  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0057-60 60 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070275 09/17/2009

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. 043838424 ANALYSIS
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 174491316 MANUFACTURE

Revised: 09/2009 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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