SERNIVO- betamethasone dipropionate spray

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Promius Pharma, LLC

INN (Միջազգային անվանումը):

BETAMETHASONE DIPROPIONATE

Կազմը:

BETAMETHASONE 0.5 mg in 1 g

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. None. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. SERNIVO Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when SERNIVO Spray is administered to a nursing woman. Safet

Ապրանքի ամփոփագիր:

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.

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

SERNIVO- BETAMETHASONE DIPROPIONATE SPRAY
PROMIUS PHARMA, LLC
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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 0.05% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1975
RECENT MAJOR CHANGES
Warnings and Precautions. Visual Disturbance. (5.2) 11/2018
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. (5.1)
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes
mellitus can result from systemic absorption of
topical corticosteroids. (5.1)
Use of topical corticosteroids may require periodic evaluation for HPA
axis suppression. (5.1)
Modify use if HPA axis suppression develops. (5.1)
High potency corticosteroids, large treatment surface areas, prolonged
use, use of occlusive dressings, altered skin
barrier, liver failure and young age may predispose patients to HPA
axis suppression. (5.1)
Pediatric patients may be more susceptible to systemic toxicity when
treated with topical corticosteroids. (5.1, 8.4)
Visual disturbances: SERNIVO Spray may increase the risk of cataracts
and