BETAMETHASONE DIPROPIONATE lotion, augmented

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Taro Pharmaceuticals U.S.A., Inc.

INN (Διεθνής Όνομα):

Betamethasone Dipropionate

Σύνθεση:

Betamethasone 0.5 mg in 1 mL

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Betamethasone dipropionate lotion (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 lotion (augmented), 0.05% 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 (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 lotion (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate lotion (augmented) on the sm

Περίληψη προϊόντος:

Betamethasone dipropionate lotion USP (augmented), 0.05% is a colorless, clear to translucent lotion supplied in 30-mL (29 g) (NDC 51672-1340-3), and 60-mL (58 g) (NDC 51672-1340-4), plastic squeeze bottles; boxes of one. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE LOTION,
AUGMENTED
TARO PHARMACEUTICALS U.S.A., INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE DIPROPIONATE
LOTION, USP (AUGMENTED) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BETAMETHASONE
DIPROPIONATE LOTION, USP (AUGMENTED).
BETAMETHASONE DIPROPIONATE LOTION, 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 USP (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 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
(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 dipropinate lotion
(augmented) may increase the risk o