CUTIVATE- fluticasone propionate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

fluticasone propionate (UNII: O2GMZ0LF5W) (fluticasone - UNII:CUT2W21N7U)

Available from:

PharmaDerm a division of Fougera Pharmaceuticals Inc.

INN (International Name):

fluticasone propionate

Composition:

fluticasone propionate 0.05 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pregnancy Category C

Product summary:

CUTIVATE® (fluticasone propionate) Ointment, 0.005% is a white to off-white translucent ointment supplied as follows: supplied as follows: 30 gram tubes NDC 10337-333-30 60 gram tubes NDC 10337-333-60 Store between 2° and 30°C (36° and 86° F).

Authorization status:

New Drug Application

Summary of Product characteristics

CUTIVATE- FLUTICASONE PROPIONATE OINTMENT
PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CUTIVATE® OINTMENT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CUTIVATE OINTMENT.
CUTIVATE (FLUTICASONE PROPIONATE) OINTMENT, 0.005%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
•
ADVERSE REACTIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other
Adverse Endocrine Effects
5.2 Local Adverse Reactions
5.3 Allergic Contact Dermatitis
5.4 Skin Infections
6 ADVERSE REACTIONS ®
CUTIVATE Ointment is a corticosteroid indicated for the relief of the
inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in adult patients. ( 1 )
®
Apply a thin film to the affected skin areas twice daily. (2)
Ointment, 0.005%, supplied in 30 g and 60 g tubes. ( 3 )
CUTIVATE Ointment is contraindicated in those patients with a history
of serious hypersensitivity to any of the
components in the preparation. ( 4 )
Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: Reversible HPA
axis suppression and resulting clinical
glucocorticoid insufficiency can occur during or after withdrawal of
treatment. Risk factors include use over large
surface area, prolonged use, use under occlusion, altered skin
barrier, liver failure, and young age. Modify use if HPA
axis suppression is suspected. (5.1)
The most common adverse reactions (<1%) were pruritus, burning,
hypertrichosis, increased erythema, urticaria,
irritation, and lightheadedness. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PHARMADERM®