If Azelaic Acid Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists 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. FINACEA (azelaic acid) Gel, 15% is a white to yellowish white opaque gel supplied in the following: 50 g tube (NDC 50419-825-02) 45 g pump (NDC 50419-825-03) Storage And Handling Therefore, Azelaic Acid 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. Since azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.Avoid contact with the eyes, mouth and other mucous membranes. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily application. -The duration of therapy is based upon the patient and the severity of the acne. Select one or more newsletters to continue. What may interact with this medicine? 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.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.Azelaic Acid Gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.Azelaic Acid Gel is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), carbomer homopolymer type C, edetate disodium, lecithin, medium-chain triglycerides, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.The pharmacodynamics of azelaic acid in association with the treatment of rosacea are unknown.The percutaneous absorption of azelaic acid after topical application of Azelaic Acid Gel could not be reliably determined. Finaceafoam.com (LEO Pharma) is not responsible for the content presented by any independent website, including any advertising claims, special offers, illustrations, names, or endorsements.

Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. 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.Azelaic Acid Gel, 15% is a white to yellowish white opaque gel. After twice daily application, Azelaic Acid Gel and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. CONTINUE » CANCEL » Available for Android and iOS devices.

COMMON BRAND(S): Finacea ... it may take several weeks of continued use before the full effects of this medication are seen. Embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the maximum recommended human dose (MRHD) based on body surface area (BSA)], rabbits given 150 mg/kg/day or 500 mg/kg/day (19 or 65 times the MRHD based on BSA) and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA) azelaic acid. FINACEA (azelaic acid) Gel, 15% is a white to yellowish white opaque gel. Select one or more newsletters to continue.