Drug Detail:Azelaic acid topical (Azelaic acid topical [ ay-ze-lay-ik-as-id-top-i-kal ])
Drug Class: Topical acne agents Topical anti-rosacea agents
Usual Adult Dose for Acne
20% Cream Formulations: Apply a thin layer to the affected area(s) 2 times a day
Comments:
- The affected area(s) should be gently washed and patted dry before application.
- This drug should be gently but thoroughly massaged into the affected area(s) in the morning and evening.
- The duration of therapy is based upon the patient and the severity of the acne.
- Improvement in patients with inflammatory lesions usually occurs within 4 weeks.
Use: Topical treatment of mild-to-moderate inflammatory acne vulgaris
Usual Adult Dose for Acne Rosacea
15% Gel/Foam Formulations: Apply a thin layer to the affected area(s) 2 times a day
Comments:
- The affected area(s) should be gently washed and dried before application with a very mild soap or soapless cleansing lotion.
- This drug should be gently but thoroughly massaged into the affected areas in the morning and evening.
- Patients may apply cosmetics once the treatment has dried.
- Patients should be reassessed if improvement is not observed after completing 12 weeks of treatment.
- For patients using foam formulations, the smallest amount of foam should be used to adequately cover the affected area(s) with a thin layer.
Use: Topical treatment of the inflammatory papules and pustules of mild to moderate rosacea
Usual Pediatric Dose for Acne
12 years and older:
20% Cream Formulations: Apply a thin layer to the affected area(s) 2 times a day
Comments:
- The affected area(s) should be gently washed and patted dry before application.
- This drug should be gently but thoroughly massaged into the affected area(s) in the morning and evening.
- Improvement in patients with inflammatory lesions usually occurs within 4 weeks.
Use: Topical treatment of mild-to-moderate inflammatory acne vulgaris
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Skin irritation on application:
- Use may be temporarily stopped or the frequency of application decreased to once a day dosing until the effects have subsided.
- If irritation persists, treatment should be discontinued.
Precautions
Safety and efficacy in the treatment of acne have not been established in patients younger than 12 years; safety and efficacy in the treatment of rosacea have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug is for topical use only, and should be used with caution around mucous membranes.
- Patients should wash their hands after application of treatment.
- Occlusive wrappings or dressings should be avoided.
Storage requirements:
- Cream: Store the tube on its side; protect from freezing.
Reconstitution/preparation techniques:
- Foam: Shake well before use.
General:
- Gel formulations may be preferred in patients with acne who have oily/greasy skin conditions.
- The duration of therapy is based upon the patient and the severity of the condition.
- Foods that cause blushing (e.g., spicy foods, thermally hot foods and drinks, alcoholic beverages) should be avoided in patients with acne rosacea.
- Limitation of use: Efficacy in the treatment of erythema in patients with rosacea in the absence of papules and pustules has not been established.
- Continuous use over several months produced optimal results.
Monitoring:
- Dermatologic: Signs/symptoms of hypopigmentation, sensitivity, or severe irritation
- Hypersensitivity: Signs/symptoms of hypersensitivity reaction
Patient advice:
- Patients should be instructed to wash the affected area with a mild, non-medicated soap and pat the area dry before application. Patients should be told to avoid washing the area too frequently or scrubbing the skin too hard.
- Patients should be told to use this drug as directed for best results.
- Patients should be advised to avoid excessive sun exposure during treatment.
- Patients should be told to report persistent irritation, sensitivity, and/or hypopigmentation to their healthcare provider.
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