AZELAIC ACID TOPICAL GEL 15% 50 G
Generic: Azelaic Acid
AZELAIC ACID TOPICAL GEL 15% 50 G
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Identification
Azelaic Acid
Azelaic Acid
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
GEL
TOPICAL
ANDA210549
Active Ingredients
| Ingredient | Strength |
|---|---|
| AZELAIC ACID | .15 g/g |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. ( 1 ) Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ( 1 ) Limitations of Use 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of azelaic acid gel. Apply and gently massage a thin layer of azelaic acid gel into the affected areas on the face twice daily (morning and evening). Wash hands immediately following application of azelaic acid gel. Cosmetics may be applied after the application of azelaic acid gel has dried. Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy. Avoid the use of occlusive dressings or wrappings. Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. For topical use. Not for oral, ophthalmic or intravaginal use. Apply a thin layer twice daily to affected area(s). ( 2 ) Use only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before applying azelaic acid gel. ( 2 ) Wash hands immediately following application. ( 2 ) Cosmetics may be applied after the application of azelaic acid gel has dried. ( 2 ) Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. ( 2 ) For topical use. ( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )
Adverse Reactions
6 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 Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily azelaic acid gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for azelaic acid gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks. Table 1: Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event. Azelaic Acid Gel, 15% N=457 (100%) Vehicle N=331 (100%) Mild N=99 (22%) Moderate N=61 (13%) Severe N=27 (6%) Mild N=46 (14%) Moderate N=30 (9%) Severe N=5 (2%) Burning/stinging/tingling 71 (16%) 42 (9%) 17 (4%) 8 (2%) 6 (2%) 2 (1%) Pruritus 29 (6%) 18 (4%) 5 (1%) 9 (3%) 6 (2%) 0 (0%) Scaling/dry skin/xerosis 21 (5%) 10 (2%) 5 (1%) 31 (9%) 14 (4%) 1 (<1%) Erythema/irritation 6 (1%) 7 (2%) 2 (<1%) 8 (2%) 4 (1%) 2 (1%) Contact dermatitis 2 (<1%) 3 (1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%) Edema 3 (1%) 2 (<1%) 0 (0%) 3 (1%) 0 (0%) 0 (0%) Acne 3 (1%) 1 (<1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%) In patients using azelaic acid formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis. Local Tolerability Studies Azelaic acid gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. Azelaic acid gel caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical trials, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies. 6.2 Postmarketing Experience The following adverse reactions have been identified post approval of azelaic acid gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure: Eyes: iridocyclitis upon accidental exposure of the eyes to azelaic acid gel. Hypersensitivity: angioedema, eye swelling, facial swelling, urticaria. Respiratory: worsening of asthma, dyspnea, wheezing. Skin reactions: application site rash.
Information for Patients
17 PATIENT COUNSELING INFORMATION Inform patients using azelaic acid gel of the following: Administration Instructions For topical use only. Before applying azelaic acid gel, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel. Wash hands immediately following application of azelaic acid gel. Cosmetics may be applied after the application of azelaic acid gel has dried. Avoid the use of occlusive dressings or wrappings. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents [see Dosage and Administration (2) ] . Hypersensitivity If allergic reactions occur, discontinue use and consult their healthcare provider [see Warnings and Precautions (5.1) ] . Skin Irritation Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of azelaic acid gel, usually during the first few weeks of treatment. If irritation is excessive or persists, or allergic reactions occur, discontinue use and consult your physician [see Warnings and Precautions (5.2) ] . Hypopigmentation Advise patients to report abnormal changes in skin color to their healthcare provider [see Warnings and Precautions (5.2) ] . Eye and Mucous Membranes Irritation Avoid contact with the eyes, mouth and other mucous membranes. If azelaic acid gel comes in contact with the eyes, wash the eyes with large amounts of water and consult their healthcare provider if eye irritation persists [see Warnings and Precautions (5.3) ] . Exacerbation of Asthma Advise patients to report any worsening of asthma to their healthcare provider [see Warnings and Precautions (5.4) ] .
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.