SERNIVO- betamethasone dipropionate spray

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Encore Dermatology Inc.

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

SERNIVO 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 SERNIVO 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 SERNIVO Spray may increase the risk of having a low birthweight infant and to use SERNIVO 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 Data ). The available data do not allow the calculation of relevant comparis

Tóm tắt sản phẩm:

SERNIVO Spray 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 controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature ]. Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

SERNIVO- BETAMETHASONE DIPROPIONATE SPRAY
ENCORE DERMATOLOGY INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SERNIVO™ SPRAY SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR SERNIVO™ SPRAY.
SERNIVO™ (BETAMETHASONE DIPROPIONATE) SPRAY, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
SERNIVO 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 SERNIVO 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
SERNIVO 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 SUSPECTED ADVERSE REACTIONS, CONTACT PROMIUS PHARMA, LLC. AT
1-888-966-8766 OR FDA AT 1-
800-FDA-1088 OR _WWW.