Dosing & Uses
Dosage Forms & Strengths
cream
- 20% (Azelex)
gel
- 15% (Finacea)
foam
- 15% (Finacea)
Acne Vulgaris
Azelex: Massage a thin layer into the affected areas on the face q12hr
Treatment of Inflammatory Papules and Pustules of Mild to Moderate Rosacea
Finacea: Massage a thin layer into the affected areas on the face q12hr
Administration
Cleanse affected area with mild soap or soapless cleansing lotion and pat dry before applying
Reassess if no improvement after 12 weeks of therapy
Acne Vulgaris
<12 years
- Safety and efficacy not established
≥12 years
- Azelex: Massage a thin layer into the affected areas on the face q12hr
Administration
Cleanse affected area with mild soap or soapless cleansing lotion and pat dry before applying
Reassess if no improvement after 12 weeks of therapy
Adverse Effects
>10%
Burning/ stinging/ tingling (4-16%)
1-10%
Pruritus (1-6%)
Scaling/ dry skin/ xerosis (1-5%)
Erythema/ irritation (1-2%)
<1%
Contact dermatitis
Edema
Acne
Postmarketing Reports
Facial burning
Irritation
Iridocyclitis after accidental exposure
Hypersensitivity reactions, including angioedema, eye swelling, facial swelling, urticaria (revised)
Worsening of asthma, dyspnea, wheezing
Application site rash
Warnings
Contraindications
Hypersensitivity to azelaic acid, propylene glycol or any of its components
Cautions
In case of known hypersensitivity to any component of the gel, avoid the use of gel dosage form; if hypersensitivity develops during treatment, discontinue and institute appropriate therapy
For dermatologic use only
Therapy has been reported to cause irritation of eyes; avoid contact with eyes and mucous membranes; if medication comes in contact with eyes, wash eyes with large amounts of water and consult a physician if eye irritation persists
Isolated cases of hypopigmentation reported after azelaic acid use; monitor patients with dark complexion for early signs of hypopigmentation
Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during first few weeks of treatment; if sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy
Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps and cleansers, exfoliants)
Avoid any foods and beverages that provoke erythema, flushing, and blushing (eg, alcoholic beverages, spicy food, hot drinks such as hot coffee and tea)
Report any abnormal changes in skin color to physician
Avoid use of occlusive dressings or wrappings
Wash hands after applying the cream
Worsening of asthma reported; consult a physician if asthma is exacerbated with therapy
Pregnancy & Lactation
Pregnancy
Azelaic acid is minimally absorbed systemically following topical route of administration; maternal use not expected to result in fetal exposure to drug
Animal data
- In animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during period of organogenesis at doses 162, 19, and 65 times maximum recommended human dose (MRHD) in rats, rabbits, and monkeys, respectively; maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies
Lactation
Azelaic acid is naturally present in human milk; when used as prescribed, azelaic acid is unlikely to be absorbed through skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of infant to drug
The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Azelaic acid is an antibacterial agent that inhibits the growth of susceptible organisms (principally Propionibacterium acnes) on the surface of the skin by inhibiting protein synthesis; may also inhibit follicular keratinization, which prevents development or maintenance of comedones
Mechanism by which it interferes with pathogenic events in rosacea is unknown
Pharmacokinetics
Half-Life: 12 hours
Absorption: systemic (4%)
Metabolism: Negligible cutaneous metabolism
Excretion: Unchanged in urine
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| azelaic acid topical - | 15 % gel |  | |
| azelaic acid topical - | 15 % gel |  | |
| azelaic acid topical - | 15 % gel |  | |
| azelaic acid topical - | 15 % gel |  | |
| Azelex topical - | 20 % cream |  | |
| Azelex topical - | 20 % cream |  | |
| Finacea topical - | 15 % foam |  | |
| Finacea topical - | 15 % foam |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
azelaic acid topical
AZELAIC ACID GEL - TOPICAL
(ay-ze-LAY-ik AS-id)
COMMON BRAND NAME(S): Finacea
USES: This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.
HOW TO USE: This medication is for use only on the skin.Clean the affected area with a mild soap or soap-free cleanser and pat dry. Apply a thin layer of medication usually twice daily, or use as directed by your doctor. Gently massage the medication into the affected area. Wash your hands well after application. Make-up may be applied after the medication has dried.Avoid getting any of this medication in the eyes or inside the nose or mouth. If it does get in your eyes, wash them right away with plenty of water. Call your doctor if eye irritation lasts.Do not use large amounts or apply this product more often than directed. Your condition will not clear faster, but the chance for side effects may be increased. Improvement is usually seen within 4 weeks. However, it may take several weeks of continued use before the full effects of this medication are seen. Inform your doctor if your symptoms do not improve or worsen.Do not apply any dressing or covering over the treated area unless directed by your doctor.
SIDE EFFECTS: Burning, stinging, tingling or itching skin may occur during the first few weeks, but then subside as your body adjusts to this medication. If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: worsening of asthma symptoms (such as increased trouble breathing, increased use of quick-relief inhalers).This medication may rarely cause abnormal changes in skin color (hypopigmentation). Dark-skinned individuals may notice a lightening in skin color. Consult your doctor or pharmacist for advice and report these changes if they occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as propylene glycol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma.Avoid any foods or liquids that may bring on redness, flushing or blushing of the skin (such as spicy foods, alcohol, hot drinks).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication may pass into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Avoid use of skin care products that can cause further irritation (such as cleansers that contain alcohol, tinctures, astringents, abrasives and peeling agents). Consult your doctor or pharmacist for details.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised March 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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