Generic equivalent of Azelaic Acid
1 SKUs available · Available to order · NABP accredited · DSCSA compliant
Azelaic acid is the generic equivalent of the brand-name drug Azelaic Acid. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Azelaic acid through Premier Pharma with same-day fulfillment on in-stock SKUs.
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.
12.1 Mechanism of Action The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown. 12.2 Pharmacodynamics The pharmacodynamics of azelaic acid in association with the treatment of rosacea are unknown. 12.3 Pharmacokinetics The percutaneous absorption of azelaic acid after topical application of azelaic acid gel could not be reliably determined. Mean plasma azelaic acid concentrations in rosacea subjects treated with azelaic acid gel twice daily for at least 8 weeks are in the range of 42 ng/mL to 63.1 ng/mL. These values are within the maximum concentration range of 24.0 ng/mL to 90.5 ng/mL observed in rosacea subjects treate…
4 CONTRAINDICATIONS None. None. ( 4 )
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 b…
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 obse…
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…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| AZELAIC ACID TOPICAL GEL 15% 50 G | 2-Day |
Premier Pharma stocks 1 Azelaic acid SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Azelaic acid is the generic equivalent of Azelaic Acid. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Azelaic acid in .15 g/g and GEL.
Azelaic acid carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
12.1 Mechanism of Action The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.
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