Azelaic Acid

Azelaic acid is a naturally occurring acid used to treat acne and rosacea.

Azelaic acid is available under the following different brand names: Azelex and Finacea.

Dosage Forms and Strengths

Cream

• 20% (Azelex)

Gel

• 15% (Finacea)

Foam

• 15% (Finacea)

Kit

• 15% (Finacea Plus)

Dosage Considerations – Should be Given as Follows:

Acne Vulgaris

Adults:

• Azelex: Massage a thin layer into the affected areas on the face every 12 hours

Children 12 years and older:

• Azelex: Massage a thin layer into the affected areas on the face every 12 hours

Children under 12 years:

• Safety and efficacy not established

Treatment of Inflammatory Papules and Pustules of Mild to Moderate Rosacea

Finacea: Massage a thin layer into the affected areas on the face every 12 hours

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

• Common side effects of azelaic acid include:
  • Burning
  • Stinging
  • Tingling
  • Itching
  • Scaling
  • Dry skin
  • Redness
  • Irritation
  • Tightness
  • Swelling
• Less common side effects of azelaic acid include:
  • Contact dermatitis
  • Swelling (edema)
  • Acne
  • Dizziness
  • Headache
  • Diarrhea
  • Nausea
  • Stomach pain
  • Loss of appetite
  • Constipation
  • Changes in taste
  • “Furry” tongue
  • Dry mouth
• Serious side effects of azelaic acid include:
• Severe application site reactions
  • Changes in skin color
  • Postmarketing side effects of azelaic acid reported include:
  • Facial burning
  • Irritation
  • Eye inflammation (iridocyclitis) after accidental exposure
  • Hypersensitivity reactions including skin swelling, eye swelling, facial swelling, hivesa (revised)
  • Worsening of asthma, shortness of breath, wheezing

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Azelaic Acid has no known severe interactions with other drugs.

Azelaic acid has no known serious interactions with other drugs.

Azelaic acid has no known moderate interactions with other drugs.

Azelaic acid has no known mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains azelaic acid. Do not take Azelex or Finacea if you are allergic to azelaic acid or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to azelaic acid, propylene glycol or any of its components

Effects of Drug Abuse

• No information available

Short-Term Effects

• Skin irritation (i.e. itching, 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.
• See "What Are Side Effects Associated with Using Azelaic Acid?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Azelaic Acid?”

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.
• Isolated cases of hypopigmentation reported after azelaic acid use; monitor patients with dark complexion for early signs of hypopigmentation.
• Skin irritation (i.e. itching, 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 (e.g., astringents, abrasive soaps and cleansers, exfoliants).
• Avoid any foods and beverages that provoke redness, flushing, and blushing (e.g., 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 and Lactation

• Azelaic acid may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk.
• Azelaic acid enters breast milk; use with caution if breastfeeding.