BETAMETHASONE DIPROPIONATE ointment, augmented

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

BETAMETHASONE DIPROPIONATE

Composition:

BETAMETHASONE 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Betamethasone dipropionate ointment (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Risk Summary There are no available data on betamethasone dipropionate ointment (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate ointment (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate ointment (augmented) on the

Product summary:

Betamethasone Dipropionate Ointment USP (Augmented), 0. 05% is supplied in: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT,
AUGMENTED
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE
DIPROPIONATE OINTMENT (AUGMENTED) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR BETAMETHASONE DIPROPIONATE OINTMENT (AUGMENTED).
BETAMETHASONE DIPROPIONATE OINTMENT (AUGMENTED) 0.05% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1983
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 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)
Limit therapy to no more than 2 consecutive weeks. (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
Ointment, 0.05% (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medicine. (4)
WARNINGS AND PRECAUTIONS
Effects on endocrine system: Betamethasone dipropionate ointment
(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)
Ophthalmic adverse reactions: Betamethasone dipropionate ointment
(augmented) may increase the
risk of cataracts and glaucoma. If visual symptoms occur, consider
referral to an ophthalmologist for
evaluation. (5.2)
ADVERSE REACTIONS
Most c