Azelaic Acid Gel

Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

• Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of azelaic acid gel.
• Apply and gently massage a thin layer of azelaic acid gel into the affected areas on the face twice daily (morning and evening).
• Wash hands immediately following application of azelaic acid gel.
• Cosmetics may be applied after the application of azelaic acid gel has dried.
• Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy.
• Avoid the use of occlusive dressings or wrappings.
• Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
• For topical use.
• Not for oral, ophthalmic or intravaginal use.

Azelaic acid gel, 15% is a white to yellowish white opaque gel. Each gram of azelaic acid gel contains 0.15 gm of azelaic acid (15% w/w).

Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug

In animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the 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

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

• Hypersensitivity
  : Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported. In case of known hypersensitivity to any component of the gel, avoid the use of azelaic acid gel. If hypersensitivity develops, discontinue treatment and institute appropriate therapy. (
  5.1 Hypersensitivity

  Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported during post marketing surveillance.

  Avoid the use of azelaic acid gel in patients with known hypersensitivity to any component of the gel. If hypersensitivity develops during treatment, discontinue azelaic acid gel and institute appropriate therapy.
  )
• Skin Reactions:
  Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. (
  5.2 Skin Reactions

  Skin irritation (i.e. pruritus, burning or stinging) may occur during use of azelaic acid gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy.

  There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.
  )
• Hypopigmentation:
  Isolated cases of hypopigmentation occurred after azelaic acid use. Monitor patients with dark complexion for early signs of hypopigmentation (
  5.2 Skin Reactions

  Skin irritation (i.e. pruritus, burning or stinging) may occur during use of azelaic acid gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy.

  There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.
  )
• Eye and Mucous Membrane Irritation:
  azelaic acid gel has been reported to cause irritation of the eyes. Avoid contact with the eyes and mucous membranes. (
  5.3 Eye and Mucous Membranes Irritation

  Azelaic acid gel has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If azelaic acid gel comes in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists

  [see Adverse Reactions (6.2)]

  .
  )
• Exacerbation of Asthma:
  Consult a physician if asthma is exacerbated with azelaic acid gel use. (
  5.4 Exacerbation of Asthma

  Worsening of asthma has been reported in patients using azelaic acid formulations including azelaic acid gel. Consult a physician if asthma is exacerbated with use of azelaic acid gel.
  )