BETAMETHASONE DIPROPIONATE spray

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Taro Pharmaceuticals U.S.A., Inc.

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Betamethasone dipropionate spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. None. Risk Summary There are no available data on betamethasone dipropionate spray use in pregnant women to evaluate 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 spray may increase the risk of having a low birthweight infant and to use betamethasone dipropionate spray on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis (see D

製品概要:

Betamethasone dipropionate spray, 0.05% is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE SPRAY
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE DIPROPIONATE SPRAY
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BETAMETHASONE DIPROPIONATE SPRAY.
BETAMETHASONE DIPROPIONATE SPRAY, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
Betamethasone dipropionate spray is a corticosteroid indicated for the
treatment of mild to moderate plaque psoriasis in
patients 18 years of age or older. (1)
DOSAGE AND ADMINISTRATION
Apply to the affected skin areas twice daily. Rub in gently. (2)
Use betamethasone dipropionate spray for up to 4 weeks and not beyond.
(2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician.
(2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous
areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Betamethasone dipropionate spray can produce reversible HPA axis
suppression with the potential for
glucocorticosteroid insufficiency during or after treatment. High
Potency corticosteroids, large treatment surface areas,
prolonged use, use of occlusive dressings, altered skin barrier, liver
failure and use in pediatric patients may predispose
to HPA axis suppression. Use of topical corticosteroids may require
periodic evaluation for HPA axis suppression.
Modify use if HPA axis suppression develops. (5.1)
Topical corticosteroids may increase the risk of cataracts and
glaucoma. If visual symptoms occur, consider referral to
an ophthalmologist. (5.2)
ADVERSE REACTIONS
The most common adverse reactions (≥1%) are application site
reactions, including pruritus, burning and/or stinging, pain,
and atrophy. (6.1)
TO REPORT SUSPE