BETAMETHASONE DIPROPIONATE- betamethasone dipropionate ointment

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

betamethasone dipropionate (UNII: 826Y60901U) (betamethasone - UNII:9842X06Q6M)

Διαθέσιμο από:

Teligent Pharma, Inc.

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Betamethasone Dipropionate Ointment 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 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 of Betamethasone Dipropionate Ointment 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 may increase the risk of having a low birthweight infant and to use Betamethasone Dipropionate Ointment on the smallest area of skin and for the shortest durat

Περίληψη προϊόντος:

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) is a white ointment supplied in the following tube sizes: 15 g tube          (NDC 52565-019-15) 50 g tube          (NDC52565-019-51) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BETAMETHASONE DIPROPIONATE - BETAMETHASONE DIPROPIONATE OINTMENT
TELIGENT PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE DIPROPIONATE
OINTMENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BETAMETHASONE DIPROPIONATE
OINTM E NT.
BETAMETHASONE DIPROPIONATE OINTMENT 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 Ointment 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 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 may
increase the risk of cataracts and
glaucoma. If visual symptoms occur, consider referral to an
ophthalmologist for evaluation (5.