BETAMETHASONE DIPROPIONATE lotion, augmented

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Betamethasone Dipropionate (UNII: 826Y60901U) (betamethasone - UNII:9842X06Q6M)

Available from:

Teligent Pharma, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone Dipropionate  Lotion 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 Lotion 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 Lotion 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 Lotion may increase the risk of having a low birthweight infant and to use Betamethasone Dipropionate Lotion on the smallest area of skin and for the shortest duration possible.

Product summary:

Betamethasone Dipropionate Lotion 0.05% is a colorless, clear to translucent lotion supplied in the following bottle sizes: 30-mL plastic bottle  (29 grams)      (NDC 52565-023-29) 60-mL plastic bottle  (58 grams)      (NDC 52565-023-59) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE LOTION,
AUGMENTED
TELIGENT PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE DIPROPIONATE LOTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BETHAMETHASONE DIPROPIONATE LOTION.
BETAMETHASONE DIPROPIONATE LOTION, USP (AUGMENTED) 0.05% FOR TOPICAL
USE
INITIAL U.S. APPROVAL: 1983
RECENT MAJOR CHANGES
Warnings and Precautions, Ophthalmic Adverse Reactions (5.2) 05/2019
INDICATIONS AND USAGE
Betamethasone Dipropionate Lotion 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 few drops to the affected skin areas once or twice daily and
massage lightly until the lotion disappears. (2)
Discontinue therapy when control is achieved. (2)
Limit therapy to no more than 2 consecutive weeks. (2)
Use no more than 50 mL 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
Lotion, 0.05% (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medicine. (4)
WARNINGS AND PRECAUTIONS
Effects on endocrine system: Betamethasone Dipropionate Lotion 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 Lotion may
increase the risk of cataracts and glaucoma. If
visual symptoms occur, consider referra