BETAMETHASONE DIPROPIONATE lotion, augmented

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Versapharm Incorporated

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 or older. Betamethasone dipropionate lotion USP (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 USP (augmented), 0.05% 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 USP (augmented), 0.05% may increase the risk of having a low birthweight infant and to use betamethasone dipr

Prehľad produktov:

Betamethasone dipropionate lotion USP (augmented), 0.05% is a colorless, clear to translucent lotion supplied in 30-mL (29 g) (NDC 61748-480-30) and 60-mL (58 g) (NDC 61748-480-60) plastic bottles. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE LOTION,
AUGMENTED
VERSAPHARM INCORPORATED
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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 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 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (<1%) are: erythema, folliculitis,
pruritus, and vesiculation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VERSAPHARM INC. – AN
AKORN COMPANY AT 1-877-254-
4381 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 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)
Lotion, 0.05% (3)
Hypersensitivity to any component of this medicine. (4)
Effects on endocrine system: Betamethasone dipropionate lotion USP
(augmented