Azelaic Acid 15% Gel

What is Azelaic Acid?

Azelaic Acid is a topical gel used in the treatment of rosacea, acne and other skin conditions. Azelaic Acid should reduce the inflammation related to rosacea when used continuously over 15 weeks. 

How does Azelaic Acid 15% Gel work?

A naturally occurring acid, Azelaic Acid aids in skin renewal. Though the exact mechanism(s) by which it interferes with the pathogenic events in rosacea are unknown,

it is believed to work as an anti-bacterial, reducing reactive oxygen species on the skin and producing an anti-inflammatory effect. In turn, this reduced inflammation results in the formation of fewer pimples and lesions. Although Azelaic Acid may also provide some reduction in redness, its clinical effectiveness in treating erythema has not been established.

Active ingredients

The active ingredient in Azelaic Acid is azelaic acid at a concentration of 0.15g in 1g. The mechanism(s) by which Azelaic Acid helps to resolve rosacea are unknown.

Inactive ingredients

Azelaic Acid contains the following inactive ingredients:

• Benzoic Acid
• Carbomer Homopolymer Type C
• Edetate Disodium
• Glyceryl Monooleate
•  Lecithin, Soybean
• Polysorbate 80
• Propylene Glycol
• Water
• Sodium Hydroxide

Those with known hypersensitivity to Azelaic Acid gel or any of its components should avoid its use.

*Note: inactive ingredients may vary between different brands of generic drugs

Which ingredients can cause an allergic reaction?

Azelaic acid does cause a burning or stinging sensation which should disappear after the first few uses, however it rarely causes a severe allergic reaction. Signs of a severe allergic reaction are skin rashes/hives, facial swelling, itchy throat, difficulty breathing and dizziness. If you experience any of these shortly after use, please get immediate medical help. 

Azelaic Acid dosage

Azelaic Acid Gel contains 15% Azelaic Acid. Squeezing the gel onto the fingertip of your index finger (from the crease to the end of your finger) will give you one dose of Azelaic Acid that is enough to cover the whole face. 

How do I use Azelaic Acid?

Dosage:  Twice daily (morning and evening)

Application:

• Cleanse skin with a very gentle or soapless cleanser and gently pat dry
• Apply a thin layer of Azelaic Acid gel to the affected areas and massage gently
• Allow to dry before applying additional skincare products or cosmetics

Avoid thermally hot beverages and foods, spicy foods, and alcoholic beverages

Not for oral, ophthalmic or intravaginal use.

What are the side effects of Azelaic Acid?

The most common side effects are stinging, burning, itching, dry skin, increased reddening of the skin and irritation. Most side effects are mild and disappear with continued use.

Warnings and Precautions:

• Hypersensitivity: Those with known hypersensitivity to Azelaic Acid gel or any of its components should avoid its use. Should hypersensitivity develop during treatment, discontinue use and consult your physician
• Skin Reactions: Itching, burning or stinging may occur during the first few weeks of use. If severe and/or persistent reactions occur, discontinue use and consult your physician
• Hypopigmentation: Isolated instances of hypopigmentation (unwanted skin lightening) have occurred. Skin should be monitored for any early signs of hypopigmentation, particularly for those with dark complexions
• Eye and Mucous Membrane Irritation: Avoid contact with the eyes and mucous membranes as irritation has been reported
• Exacerbation of Asthma: If asthma becomes exacerbated, discontinue use and consult your physician

In patients using Azelaic Acid formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis (excessive hair growth), reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis (oral herpes also known as cold sores or fever blisters). If any of these events occur, discontinue use and consult your physician.

The following adverse reactions have been identified post approval of Azelaic Acid gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

• Eyes: iridocyclitis (inflammation of the iris) upon accidental exposure of the eyes to Azelaic Acid gel
• Hypersensitivity: angioedema (swelling below the skin), eye swelling, facial swelling, urticaria (hive-like, bumpy rash)
• Respiratory: worsening of asthma, difficult or labored breathing, wheezing

If you experience any of these adverse reactions, discontinue use and consult your physician immediately.

Contraindications

Do not use Azelaic Acid if you are allergic to any of its ingredients. You should inform your doctor if this is the case and they can recommend an alternative treatment. 

Drug interactions

There are no known interactions between Azelaic Acid and other drugs.