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Drug overview for AZELAIC ACID (azelaic acid):
Generic name: AZELAIC ACID (ay-ze-LAY-ik AS-id)
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
Azelaic acid is a naturally occurring aliphatic dicarboxylic acid that exhibits various dermatologic effects including antibacterial and antiproliferative activity.
No enhanced Uses information available for this drug.
Generic name: AZELAIC ACID (ay-ze-LAY-ik AS-id)
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
Azelaic acid is a naturally occurring aliphatic dicarboxylic acid that exhibits various dermatologic effects including antibacterial and antiproliferative activity.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for AZELAIC ACID (azelaic acid) have been approved by the FDA:
Indications:
Acne rosacea
Professional Synonyms:
Acne erythematosa
Rosacea
Indications:
Acne rosacea
Professional Synonyms:
Acne erythematosa
Rosacea
The following dosing information is available for AZELAIC ACID (azelaic acid):
The manufacturer states that safety and efficacy of azelaic acid cream in children younger than 12 years of age have not been established. The manufacturer states that safety and efficacy of azelaic acid gel in pediatric patients have not been established.
Azelaic acid is applied topically to the skin as a 20% cream or 15% gel. Prior to application of the cream or gel, the affected areas should be cleansed and dried. The cream or gel is then applied and massaged gently into the affected areas.
Occlusive dressings or wrappings should not be used, and hands should be washed after applying the cream or gel. Cosmetics may be applied to the skin after the gel has dried. The cream or gel should not be applied to the eye.
In addition, contact with the mouth, eyes, and other mucous membranes should be avoided. If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists. The manufacturer states that patients receiving azelaic acid gel for the treatment of rosacea should be instructed to avoid spicy foods, thermally hot foods and drinks, and alcoholic beverages and to use only very mild soaps or soapless cleansing lotions for facial cleaning during therapy with the drug.
Skin irritation (e.g., pruritus, burning, stinging) may occur during the initial weeks of therapy with azelaic acid cream or gel; if irritation is excessive or persists, the drug should be discontinued and the clinician should be contacted. Patients with dark complexions should be monitored for early signs of hypopigmentation during azelaic acid therapy.
Occlusive dressings or wrappings should not be used, and hands should be washed after applying the cream or gel. Cosmetics may be applied to the skin after the gel has dried. The cream or gel should not be applied to the eye.
In addition, contact with the mouth, eyes, and other mucous membranes should be avoided. If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists. The manufacturer states that patients receiving azelaic acid gel for the treatment of rosacea should be instructed to avoid spicy foods, thermally hot foods and drinks, and alcoholic beverages and to use only very mild soaps or soapless cleansing lotions for facial cleaning during therapy with the drug.
Skin irritation (e.g., pruritus, burning, stinging) may occur during the initial weeks of therapy with azelaic acid cream or gel; if irritation is excessive or persists, the drug should be discontinued and the clinician should be contacted. Patients with dark complexions should be monitored for early signs of hypopigmentation during azelaic acid therapy.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| AZELAIC ACID 15% GEL | Maintenance | Adults apply a thin layer to the affected area(s) by topical route 2 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| AZELAIC ACID 15% GEL | Maintenance | Adults apply a thin layer to the affected area(s) by topical route 2 times per day |
The following drug interaction information is available for AZELAIC ACID (azelaic acid):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for AZELAIC ACID (azelaic acid):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Asthma |
The following adverse reaction information is available for AZELAIC ACID (azelaic acid):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 5 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Angioedema Asthma exacerbation Dyspnea Urticaria Wheezing |
There are 15 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dry skin Erythema Paresthesia Pruritus of skin Skin inflammation Stinging of skin |
None. |
| Rare/Very Rare |
|---|
|
Abnormal desquamation Application site rash Facial edema Hirsutism Ocular irritation Periorbital edema Recurrent herpes simplex labialis Skin hypopigmentation Vitiligo |
The following precautions are available for AZELAIC ACID (azelaic acid):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for AZELAIC ACID (azelaic acid):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for AZELAIC ACID (azelaic acid)'s list of indications:
| Acne rosacea | |
| L71.0 | Perioral dermatitis |
| L71.9 | Rosacea, unspecified |
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