AZELAIC ACID gel

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Alvogen, Inc.

INN (International Nazwa):

AZELAIC ACID

Skład:

AZELAIC ACID 0.15 g in 1 g

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

New Drug Application Authorized Generic

Charakterystyka produktu

AZELAIC ACID- AZELAIC ACID GEL
ALVOGEN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZELAIC ACID GEL SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR AZELAIC ACID GEL.
AZELAIC ACID GEL, 15% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Gel, 15% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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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 CONTACT ALVOGEN AT
1-866-770-3024 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2015
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 Hypersensitivity
5.2 Skin Reactions
5.3 Eye and Mucous Membranes Irritation
Apply a thin layer of Azelaic Acid Gel twice daily to affected
area(s). (2)
Use only very mild soaps or soapless cleansing lotion before applying
Azelaic Acid Gel. (2)
Cosmetics may be applied after the application of Azelaic Acid Gel has
dried. (2)
Avoid spicy foods, thermally hot foods and drinks, alcoholic
beverages. (2)
Not for oral, ophthalmic or intravaginal use. (2)
In case of known hypersensitivity to any component of the gel, avoid
the use of Azelaic Acid Gel. If hypersensitivity
develops during treatment, discontinue Azelaic Acid Gel and institute
appropriate therapy. (5.1)
Skin irritation (i.e. pruritus, burning or stinging) may occur,
usually during the first few weeks of treatment