FLUOCINONIDE cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

fluocinonide (UNII: 2W4A77YPAN) (fluocinonide - UNII:2W4A77YPAN)

Commercializzato da:

Fougera Pharmaceuticals Inc.

INN (Nome Internazionale):

fluocinonide

Composizione:

fluocinonide 1 mg in 1 g

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4 ) ]. Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week. Fluocinonide cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. None. Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. T

Dettagli prodotto:

FLUOCINONIDE CREAM USP, 0.1% is white to off-white in color and is supplied in tubes as follows: 30 g      NDC 0168-0457-30 60 g      NDC 0168-0457-60 120 g    NDC 0168-0457-04 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep the tube tightly closed.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FLUOCINONIDE- FLUOCINONIDE CREAM
FOUGERA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOCINONIDE CREAM USP, 0.1% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOCINONIDE CREAM
USP, 0.1%.
FLUOCINONIDE CREAM USP, 0.1%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the
relief of the inflammatory and pruritic manifestations of
corticosteroid responsive dermatoses in patients 12 years of age or
older (1).
Limitation of Use:
•
•
•
DOSAGE AND ADMINISTRATION
For topical use only. Fluocinonide cream USP, 0.1% is not for
ophthalmic, oral, or intravaginal use. (2)
PSORIASIS: apply a thin layer once or twice daily to the affected skin
areas. (2)
ATOPIC DERMATITIS: apply a thin layer once daily to the affected skin
areas. (2)
CORTICOSTEROID RESPONSIVE DERMATOSES, OTHER THAN PSORIASIS OR ATOPIC
DERMATITIS: apply a thin layer once or twice
daily to the affected areas. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 0.1% (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
THE MOST COMMONLY REPORTED ADVERSE REACTIONS (≥1%) WERE HEADACHE,
APPLICATION SITE BURNING,
NASOPHARYNGITIS, AND NASAL CONGESTION. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FOUGERA AT
1-800-645-9833 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
Treatment beyond 2 consecutive weeks is not recommended and the total
dosage should not exceed 60 g per week
because of the potential for the drug to suppress the
hypothalamic-pituitary-adrenal (HPA) axis (1).
Avoid use on the face, groin, or axillae (1.2).
Avoid use in perioral dermatitis or rosacea.
Fluocinonide cream USP, 0.1% has been shown to suppress the HPA axis.
Systemic absorption of fluocinonide cream
USP, 0.1%