Pregnancy, lactation. Avoid contact with eyes, mouth or other mucous membranes. Occlusive dressings or wrappings should not be used. Recommend patient to use only very mild soaps or soapless cleansing lotions for facial washing. Monitor for hypopigmentation in patients with dark complexion. Safety and efficacy not established in children <12 yr.
Lactation: enters breast milk; use with caution
Indication
Acne vulgaris, Rosacea, Rosacea melasma, Post inflammatory hyperpigmentation
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Mode of Action
Azelaic acid is a naturally-occurring aliphatic dicarboxylic acid. The exact mechanism of action in treatment of acne vulgaries has not been fully established. It is believed to inhibit the growth of susceptible organisms (mainly Propionibacteria Acnes) on the skin surface, and inhibits follicular keratinisation thus restricts the development of comedones. Mechanism of action in the treatment of rosacea is unknown.
Interaction
There have been no formal studies of the interaction of Azelaic Acid Gel with other drugs.
Pregnancy Category Note
Pregnancy Category: B
Lactation: enters breast milk; use with caution
Adult Dose
Topical
Acne vulgaris
Adult: As 20% cream: Apply into the affected areas bid (morning and evening). Improvement may be detectable w/n 4 wk. Duration of treatment: Up to 6 mth.
Topical
Rosacea
Adult: Apply into the affected areas bid (morning and evening). Improvement occurs in 4-8 wk.
Child Dose
Topical
Acne vulgaris, Rosacea
Child: >12 yr Same as adult dose.
<12 years: Safety and efficacy not established
Renal Dose
N/A
Administration
Cleanse affected area with mild soap or soapless cleansing lotion and pat dry before applying. Apply thinly into the affected areas bid (morning and evening) after cleansing.
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The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.