Drug: Azelex

AZELEX (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Structural Formula: HOOC-(CH2)7-COOH.
Chemical Name: 1,7-heptanedicarboxylic acid
Empirical Formula: C9H16O4
Molecular Weight: 188.22 Active Ingredient: Each gram of AZELEX contains azelaic acid..........0.2 gm (20% w/w). Inactive Ingredients: cetearyl octanoate; glycerin; glyceryl stearate and cetearyl alcohol and cetyl palmitate and cocoglycerides; PEG-5 glyceryl stearate; propylene glycol; and purified water. Benzoic acid is present as a preservative.

Source: http://www.rxlist.com

During U.S. clinical trials with AZELEX (azelaic acid cream) Cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of AZELEX Cream. In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis. Read the Azelex (azelaic acid cream) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

After the skin is thoroughly washed and patted dry, a thin film of AZELEX (azelaic acid cream) Cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of AZELEX (azelaic acid cream) Cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.

Source: http://www.rxlist.com

No information provided. Last reviewed on RxList: 11/11/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

AZELEX (azelaic acid cream) Cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

Source: http://www.rxlist.com

AZELEX (azelaic acid cream) Cream is contraindicated in individuals who have shown hypersensitivity to any of its components. Last reviewed on RxList: 11/11/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

Source: http://www.rxlist.com

AZELEX (azelaic acid cream) Cream is supplied in a closed orifice tube with a white, spiked screwcap in the following sizes: 30 g - NDC 0023-8694-30
50 g - NDC 0023-8694-50 Note: Protect from freezing. Store product on its side. Store between 15° - 30° C (59° - 86° F). Distributed by: Allergan, Inc., Irvine, California 92612, U.S.A. Made in Italy. FDA Rev date: 6/10/2003 Last reviewed on RxList: 11/11/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General If sensitivity or severe irritation develop with the use of AZELEX (azelaic acid cream) Cream, treatment should be discontinued and appropriate therapy instituted. Carcinogenesis, mutagenesis, impairment of fertility: Azelaic acid is a human dietary component of a simple molecular structure that does not suggest carcinogenic potential, and it does not belong to a class of drugs for which there is a concern about carcinogenicity. Therefore, animal studies to evaluate carcinogenic potential with AZELEX (azelaic acid cream) Cream were not deemed necessary. In a battery of tests (Ames assay, HGPRT test in Chinese hamster ovary cells, human lymphocyte test, dominant lethal assay in mice), azelaic acid was found to be nonmutagenic. Animal studies have shown no adverse effects on fertility. Pregnancy Teratogenic Effects: Pregnancy Category B. Embryotoxic effects were observed in Segment I and Segment II oral studies with rats receiving 2500 mg/kg/day of azelaic acid. Similar effects were observed in Segment II studies in rabbits given 150 to 500 mg/kg/day and in monkeys given 500 mg/kg/day. The doses at which these effects were noted were all within toxic dose ranges for the dams. No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid concentration of 25 µg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when AZELEX (azelaic acid cream) Cream is administered to a nursing mother. Pediatric Use Safety and effectiveness in pediatric patients under 12 years of age have not been established. Geriatric Use Clinical studies of AZELEX (azelaic acid cream) Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Last reviewed on RxList: 11/11/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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