FINACEA- azelaic acid gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)

Available from:

A-S Medication Solutions

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FINACEA® (azelaic acid) Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. None. There are no adequate and well-controlled studies in pregnant women. Therefore, FINACEA Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. E

Product summary:

Product: 50090-3032 NDC: 50090-3032-0 50 g in a TUBE / 1 in a CARTON

Authorization status:

New Drug Application

Summary of Product characteristics

FINACEA- AZELAIC ACID GEL
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINACEA GEL SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR FINACEA GEL.
FINACEA (AZELAIC ACID) GEL, 15% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions:
INDICATIONS AND USAGE
FINACEA (azelaic acid) Gel, 15% is indicated for topical treatment of
the inflammatory papules and pustules of mild to
moderate rosacea. Efficacy for treatment of erythema in rosacea in the
absence of papules and pustules has not been
evaluated. (1) (1)
DOSAGE AND ADMINISTRATION
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•
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DOSAGE FORMS AND STRENGTHS
Gel, 15% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
The most common adverse reactions are burning/stinging/tingling (29%),
pruritus (11%), scaling/dry skin/xerosis (8%)
and erythema/irritation (4%). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAYER HEALTHCARE AT
1-866-463-3634 OR FDA AT 1-800-
FDA-1088 OR www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
®
®
Worsening Exacerbation of Asthma (5.4) 8/2016
®
Apply a thin layer of FINACEA Gel twice daily to affected area(s). (2)
Use only very mild soaps or soapless cleansing lotion before applying
FINACEA Gel. (2)
Cosmetics may be applied after the application of FINACEA Gel has
dried. (2)
Avoid spicy foods, thermally hot foods and drinks, alcoholic
beverages. (2)
Not for oral, ophthalmic or intravaginal use. (2)
_Hypersensitivity_: In case of known hypersensitivity to any component
of the gel, avoid the use of FINACEA Gel. If
hypersensitivity develops during treatment, discontinue FINACEA Gel
and institute appropriate therapy. (5.1)
_Skin Reactions:_ Skin irritation (i.e. pruritus, burning or stinging)
may occur, usually during the first few weeks of
treatment with FINACEAGel. If sensitivity or severe