BETAMETHASONE DIPROPIONATE cream, augmented

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone dipropionate cream (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. Betamethasone dipropionate cream (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Betamethasone dipropionate cream (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. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticost

Product summary:

Betamethasone dipropionate cream USP (augmented), 0.05% is a white cream supplied in 15 g (NDC 68071-4556-5) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM,
AUGMENTED
NUCARE PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE
DIPROPIONATE CREAM (AUGMENTED) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR BETAMETHASONE DIPROPIONATE CREAM (AUGMENTED).
BETAMETHASONE DIPROPIONATE CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
Betamethasone dipropionate cream (augmented), 0.05% is a
corticosteroid indicated for the relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses in patients 13 years of
age and older. ( 1)
DOSAGE AND ADMINISTRATION
Apply a thin film to the affected skin areas once or twice daily. ( 2)
Discontinue therapy when control is achieved. ( 2)
Use no more than 50 g per week. ( 2)
Do not use with occlusive dressings unless directed by a physician. (
2)
Avoid use on the face, groin, or axillae, or if skin atrophy is
present at the treatment site. ( 2)
Not for oral, ophthalmic, or intravaginal use. ( 2)
DOSAGE FORMS AND STRENGTHS
Cream, 0.05% ( 3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medicine. ( 4)
WARNINGS AND PRECAUTIONS
Effects on endocrine system: Betamethasone dipropionate cream
(augmented) can cause reversible
HPA axis suppression with the potential for glucocorticosteroid
insufficiency during and after withdrawal
of treatment. Risk factor(s) include the use of high-potency topical
corticosteroids, use over a large
surface area or to areas under occlusion, prolonged use, altered skin
barrier, liver failure, and use in
pediatric patients. Modify use should HPA axis suppression develop. (
5.1, 8.4)
ADVERSE REACTIONS
The most common adverse reaction reported in 0.4% of adult patients is
stinging. ( 6.1)
The most common adverse reactions reported in 10% of pediatric
patients are signs of skin atrophy,
telangiectasia, bruising, shininess. ( 6.1, 8.4)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO AT