Country: United States
Language: English
Source: NLM (National Library of Medicine)
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)
Bayer HealthCare Pharmaceuticals Inc.
AZELAIC ACID
AZELAIC ACID 0.15 g in 1 g
TOPICAL
PRESCRIPTION DRUG
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
FINACEA (azelaic acid) Gel, 15% is a white to yellowish white opaque gel supplied in the following: Discard the pump 8 weeks after opening. Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].
New Drug Application
FINACEA- AZELAIC ACID GEL BAYER HEALTHCARE PHARMACEUTICALS INC. ---------- 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 • • • • • DOSAGE FORMS AND STRENGTHS Gel, 15% (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS • • • • • 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: 8/2016 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 sensitivi Read the complete document