Azelex Topical: Uses, Side Effects, Interactions, Warnings & Dosing (Azelaic Acid)

The most common skin ailment in the U.S. is acne, and an estimated 85% of Americans have experienced the condition at some point in their lives. Of those, 15% develop severe acne which can lead to scarring. Caused by skin pores or hair follicles becoming clogged with dead skin cells or oil, acne manifests as pimples, black and white heads, red bumps and even cysts. A 2008 study by the American Academy of Dermatology determined that acne was slightly more prevalent in women, and in spite of the common misconception that acne is a "teenage" condition, "...a significant number of patients either continue to experience acne or develop new-onset acne after their teenaged years." Indeed, the average age of people with acne has increased over the last decade from 20.5 years to 26.5 years-old.

Acne commonly appears on the face, back and chest although it can develop anywhere on the body. Some cases can be relatively mild and temporary, easily controlled with proper hygiene or medications, while other instances can become infected with white pus, or could even signal more serious health conditions; although acne accompanies these more serious conditions rather than causing them. In spite of the relatively benign impact acne has on physical health, the condition may have negative psychological effects. According to Dermatologist Dr. Yoram Harth, MD, "One study found 96% of people with acne have reported feeling depressed over their condition. This has led 46% to develop self-esteem issues...and has caused 31% to stay at home, declining to participate in social activities."

The good news is that many remedies, both prescription and over-the-counter drugs, are available to mitigate acne. This article provides an overview of one popular acne medication - Azelex Topical - with uses, side effects, interactions, warnings, and dosing being featured.

Key Takeaways

  • Azelex Cream should be applied twice daily onto clean and dry affected areas of the skin.

  • Common side effects of Azelex include skin irritation, redness, and dryness at the application site.

  • Mild and temporary side effects usually resolve within a few days or weeks, but severe reactions are rare.

  • Azelex contains 20% azelaic acid and has been shown to reduce inflammatory lesions and improve skin appearance.

Skinoren Cream
20% Cream

Prescription required. Product of UK/EU. Shipped from United Kingdom of Great Britain and Northern Ireland. Azelex is also marketed internationally under the name Skinoren Cream.

Skinoren Cream
20% Cream

Prescription required. Product of UK/EU. Shipped from United Kingdom of Great Britain and Northern Ireland. Azelex is also marketed internationally under the name Skinoren Cream.


Generic equivalents for Azelex... What are generics?

Azelaic Acid
20% Cream

Prescription required. Product of India. Shipped from Mauritius.


To comply with Canadian International Pharmacy Association regulations you are permitted to order a 3-month supply or the closest package size available based on your personal prescription. read more

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How to use Azelex Cream

The proper application method for Azelex Cream, also known as Azelaic acid, is to gently massage a thin layer onto the affected areas of the skin twice daily. Do not apply to sunburned, windburned, dry, chapped, irritated, or broken or inflamed skin. This topical cream is commonly used to treat acne and rosacea. It works by reducing inflammation and decreasing the production of keratin, which can clog pores and lead to breakouts.

When applying Azelex Cream, it is important to ensure that the affected areas are clean and dry before application. Avoid contact with the eyes, mouth, other mucous membranes or open wounds. Following these guidelines will help maximize the effectiveness of this medication in treating skin conditions.

Understanding how to use Azelex Cream properly is essential in order to minimize potential side effects associated with azelaic acid-based treatments.

What Are the Side Effects of Azelaic acid?

Adverse reactions can occur with the use of Azelaic acid. It is important to be aware of the potential side effects when considering this medication.

Common side effects reported by users include skin irritation, redness, and dryness at the application site. These symptoms are usually mild and resolve on their own without any intervention.

However, in rare cases, more serious reactions such as severe allergic dermatitis or worsening of existing skin conditions may occur. If any unusual or serious symptoms develop, or if severe irritation occurs, it is advisable to discontinue the use of Azelaic acid and consult a healthcare professional for further guidance.

Understanding the possible side effects allows individuals to make informed decisions regarding their skincare regimen and ensures appropriate care is provided if adverse reactions arise.

Skin irritation, redness, and dryness are commonly reported symptoms associated with the use of azelaic acid. These side effects are generally mild and temporary, resolving on their own within a few days or weeks of treatment initiation. However, if these symptoms persist or worsen over time, it is advisable to consult a healthcare professional for further evaluation to avoid any potential serious allergic reaction.

In rare cases, more serious allergic reactions may occur, characterized by itching, swelling, rash, severe dizziness, or difficulty breathing. If any of these serious side effects occur, immediate medical attention should be sought.

It is important to note that individual responses to medication can vary significantly, and not all individuals will experience the same side effects.

The Azelex container should be stored safely, out of reach of young children and pets. If accidental ingestion of excessive amounts of Azelex occurs, either by a toddler or pet, the local poison control center should be immediately contacted.

Dosage for Azelex - azelaic acid concentration

Optimal dosing strategies for Azelaic acid concentration in the treatment of various dermatological conditions should be carefully considered to ensure effective therapeutic outcomes while minimizing potential adverse events.

Azelaic acid is a topical medication commonly used for the management of acne vulgaris and rosacea. The recommended dosage of Azelex for a formulation containing 20% Azelaic acid, is twice daily. Clinical Studies have demonstrated its efficacy in reducing inflammatory lesions and improving overall skin appearance.

However, individual outcomes may vary, and it is important to follow the guidance of a healthcare professional when determining the appropriate concentration and frequency of use for each patient. Understanding potential interactions with other drugs, substances, or supplements is also crucial in ensuring optimal treatment outcomes with Azelex.

What Drugs, Substances, or Supplements Interact with Azelex?

Concomitant use of Azelex with certain medications or substances may potentially affect its pharmacokinetics and therapeutic efficacy. It is important to be aware of these potential interactions to ensure safe and effective use of this medication.

Azelex has been reported to interact with other topical acne medications such as benzoyl peroxide, salicylic acid, and tretinoin. Concurrent use of these agents may increase the risk of skin irritation or dryness.

Additionally, Azelex may interact with certain antibiotics such as erythromycin and clindamycin, which are commonly used for the treatment of acne. These interactions may alter the absorption or metabolism of Azelex, leading to reduced effectiveness.

Therefore, it is advisable to consult a healthcare professional before using Azelex in combination with other medications or substances.

Understanding the potential drug interactions is crucial not only during regular medication usage but also during special circumstances such as pregnancy and breastfeeding. These precautions will prevent common adverse reactions occurring.

Pregnancy Categories

Categorizing medications into pregnancy categories provides healthcare professionals with information about the potential risks and benefits of using a particular drug during pregnancy. This classification system helps in making informed decisions regarding medication use for pregnant individuals. Pregnancy categories are based on available data from animal and human studies and provide an assessment of the potential fetal risk associated with a specific drug.

These categories range from A to X, with Category A indicating controlled studies in pregnant women that have demonstrated no risk to the fetus, and Category X indicating evidence of fetal abnormalities or risks outweighing any potential benefits. By assigning drugs to these categories, healthcare professionals can guide pregnant patients towards safer options when it comes to medication use.

Understanding the pregnancy category is essential as it influences the recommended dosages and administration guidelines for a particular drug during pregnancy.

Azelex During Pregnancy and Breastfeeding

Azelex falls under Pregnancy Category B which is a classification used by the FDA to indicate, among other findings, that no adequate human studies have been undertaken, but that animal studies show no fetal risk. Limited data suggests that the systemic absorption of Azelaic acid through topical application is minimal.

Since there are no well-controlled human studies, caution is still advised when using Azelex during pregnancy and breastfeeding. It is recommended to weigh the potential benefits against the potential risks before making a decision. Consulting with a healthcare provider is crucial in order to make an informed decision based on individual circumstances.

Information for Patients

Patients should be provided with accurate and up-to-date information regarding the use of Azelex during pregnancy and breastfeeding in order to make informed decisions about their safety and well-being. It is essential for healthcare professionals to educate patients on the potential risks and benefits associated with using this medication while pregnant or breastfeeding.

Azelex, also known as Azelaic acid, is a topical cream commonly used to treat acne. However, its safety profile during pregnancy and breastfeeding has not been extensively studied. Limited data suggests that systemic absorption of Azelex is minimal, which may reduce the risk of harm to the fetus or nursing infant.

Nonetheless, it is important for patients to consult with their healthcare provider before using Azelex during these periods to ensure individual circumstances are considered.

DOSAGE AND ADMINISTRATION

Dosage and administration guidelines for medications during pregnancy are crucial in ensuring safe and effective utilization of drugs by pregnant women. The appropriate dosage and administration of medications take into consideration the physiological changes that occur during pregnancy, as well as potential risks to both the mother and the developing fetus.

Healthcare professionals must carefully evaluate the benefits versus potential risks associated with medication use in pregnant women, considering factors such as gestational age, maternal health conditions, pharmacokinetics of the drug, and available evidence from clinical trials or post-marketing surveillance. It is essential to strike a balance between therapeutic efficacy and minimizing harm to both the mother and fetus.

Clear communication between a health care professional and expectant mothers is vital to ensure adherence to prescribed dosages, prompt reporting of any adverse effects, regular monitoring, and adjustment of treatment plans if necessary. By following recommended dosage and administration guidelines, healthcare professionals can optimize outcomes for pregnant individuals while minimizing potential risks.

Are you currently using Azelex Cream?

Azelex cream contains Azelaic acid, which is known for its effectiveness in treating inflammatory papules and pustules of mild to moderate rosacea. If you are using Azelex cream, it is crucial to follow the instructions provided by your healthcare professional or pharmacist. It should be applied twice daily, in the morning and evening, on clean and dry skin affected by rosacea. Gently massage a thin layer of the cream onto the affected areas until fully absorbed. Remember to avoid contact with the eyes, mouth, nose, and other mucous membranes.

Treatment of Inflammatory Papules and Pustules of Mild to Moderate Rosacea

Azelex Cream is a topical medication that has been approved by the FDA for the treatment of inflammatory papules and pustules associated with mild to moderate rosacea. It contains Azelaic acid, which is thought to work by reducing the production of keratin, a protein found in the skin that can contribute to inflammation. Azelaic acid also has antibacterial properties that may help to reduce bacteria on the skin's surface. Clinical Studies have shown that Azelex Cream can effectively reduce both the number and severity of inflammatory lesions in patients with rosacea. The recommended dosage is twice daily application to affected areas after cleansing and drying the skin. However, it is important to note that individual responses may vary, and it may take several weeks before significant improvement is seen.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The potential risks and effects on carcinogenesis, mutagenesis, and impairment of fertility associated with the usage of Azelex Cream should be carefully considered. Carcinogenesis refers to the development of cancer, while mutagenesis involves the induction of genetic mutations. Impairment of fertility pertains to difficulties in conceiving or maintaining a pregnancy.

It is important for healthcare professionals to be aware of these potential adverse effects when prescribing Azelex Cream as a treatment option for inflammatory papules and pustules of mild to moderate rosacea. Understanding the potential risks allows healthcare professionals to make informed decisions and provide appropriate guidance to their patients. Furthermore, considering these effects can help ensure that patients are well-informed about all aspects related to their treatment plan.

Teratogenic Effects

Teratogenic effects, which refer to the potential harm caused to a developing fetus during pregnancy, are an important consideration when assessing the safety of any medication. It is crucial for healthcare professionals to have a thorough understanding of teratogenicity in order to make informed decisions regarding medication use during pregnancy.

Various factors contribute to the teratogenic potential of a drug, such as its chemical structure and mechanism of action. Animal studies play a vital role in determining teratogenic effects, although caution must be exercised when extrapolating these findings to humans.

Additionally, it is essential to consider the potential benefits versus risks when prescribing medications to pregnant women. With this knowledge, healthcare providers can provide evidence-based recommendations and counseling that prioritize the well-being of both mother and child.

Nursing Mothers

Moving on from discussing the teratogenic effects of Azelex topical, it is important to consider its impact on nursing mothers.

Limited information is available regarding the excretion of Azelex into breast milk and its potential effects on infants. Therefore, caution should be exercised when considering the use of Azelex by breastfeeding women. Azelex should not be applied to the nipple area to avoid nursing infants from ingesting the medication.

In general, healthcare providers may suggest alternative treatments or advise temporary discontinuation of using Azelex therapy while breastfeeding to avoid any potential risks to the infant. However, this decision should be made after carefully weighing the benefits against the possible adverse effects.

Pediatric Use

Regarding the use of Azelex in pediatric patients, it is essential to examine its impact on children and the necessary precautions for ensuring their well-being and safety. Acne does not usually manifest in children prior to puberty, but it can occur at any age, typically between 11 to 30 years old. However, newborns, infants, younger children and adults are usually affected by different types of acne, and prescribed treatment or medications will be contingent on a number of factors including the severity of the condition.

While Azelex has been primarily observed in adults for the treatment of acne vulgaris, limited data suggest that it may also be a viable option for pediatric patients. Indeed, according to the manufacturer's monogram; "Safety and efficacy of 20% cream [has] not established in children <12 years of age. Safety and efficacy of 15% gel [has] not been established. However, caution must be exercised when considering its use in children, as there is currently a lack of sufficient evidence regarding its safety and efficacy in this population.

The age-specific dosing guidelines have not been established, and potential adverse effects on growth and development need to be carefully evaluated. Additionally, close monitoring is crucial to detect any systemic absorption or systemic adverse effects.

Geriatric Use

The impact of Azelex on geriatric patients and the considerations for its safe and effective use in this population require careful evaluation. Geriatric patients, typically those aged 65 years and above, may have age-related changes in their skin physiology that can affect drug absorption, distribution, metabolism, and excretion. Additionally, they may have comorbidities or may be taking multiple medications which can increase the risk of drug interactions or adverse effects. Therefore, it is important to consider these factors when prescribing Azelex to geriatric patients. No studies have been conducted and insufficient observation is available specifically on the use of Azelex in this population, however, extrapolation from adult data suggests that no dosage adjustment is necessary based solely on age. Further research is needed to fully understand the safety and efficacy of Azelex in geriatric patients.

DOSAGE AND ADMINISTRATION

Dosage and administration guidelines for medications during pregnancy are crucial in ensuring safe and effective utilization of drugs by pregnant individuals. The appropriate dosage and administration of medications take into consideration the physiological changes that occur during pregnancy, as well as potential risks to both the mother and the developing fetus.

Healthcare professionals must carefully evaluate the benefits versus potential risks associated with medication use in pregnant individuals, considering factors such as gestational age, maternal health conditions, pharmacokinetics of the drug, and available evidence from clinical trials or post-marketing surveillance. It is essential to strike a balance between therapeutic efficacy and minimizing harm to both the mother and fetus.

Clear communication between a health care professional and pregnant individuals is vital to ensure adherence to prescribed dosages, prompt reporting of any adverse effects, regular monitoring, and adjustment of treatment plans if necessary. By following recommended dosage and administration guidelines, healthcare professionals can optimize outcomes for pregnant individuals while minimizing potential risks.

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Azelaic Acid Information

Azelaic Acid Topical (ay ze lay' ik) Azelex® Cream Finacea® Gel Finacea® Foam Heptanedicarboxylic acid Lepargylic acid

Azelaic acid gel and foam is used to clear the bumps, lesions, and swelling caused by rosacea (a skin disease that causes redness, flushing, and pimples on the face). Azelaic acid cream is used to treat the pimples and swelling caused by acne. Azelaic acid is in a class of medications called dicarboxylic acids. It works to treat rosacea by decreasing the swelling and redness of the skin. It works to treat acne by killing the bacteria that infect pores and by decreasing production of keratin, a natural substance that can lead to the development of acne.

Azelaic acid comes as a gel, foam, and a cream to apply to the skin. It is usually applied twice a day, in the morning and the evening. To help you remember to use azelaic acid, use it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use azelaic acid exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Be careful not to get azelaic acid in your eyes or mouth. If you do get azelaic acid in your eyes, wash with plenty of water and call your doctor if your eyes are irritated. Azelaic acid foam is flammable. Stay away from open fire, flames, and do not smoke while you are applying azelaic acid foam, and for a short time afterwards. To use the gel, foam, or cream, follow these steps: Wash the affected skin with water and a mild soap or soapless cleansing lotion and pat dry with a soft towel. Ask your doctor to recommend a cleanser, and avoid alcoholic cleansers, tinctures, abrasives, astringents, and peeling agents, especially if you have rosacea. Shake the azelaic acid foam well before use. Apply a thin layer of gel, or cream to the affected skin. Gently and thoroughly massage it into the skin. Apply a thin layer of foam to the entire face including cheeks, chin, forehead, and nose. Do not cover the affected area with any bandages, dressings, or wrappings. You may apply make-up to your face after the medication is dry. Wash your hands with soap and water after you finish handling the medication.

Before using azelaic acid, tell your doctor and pharmacist if you are allergic to azelaic acid or any other medications. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. tell your doctor if you have or have ever had asthma, or cold sores that keep coming back. tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using azelaic acid, call your doctor. you should know that azelaic acid may cause changes in your skin color, especially if you have a dark complexion. Tell your doctor if you notice any changes in your skin color.

If you have rosacea, you should avoid foods and drinks that cause you to flush or blush. These may include alcoholic drinks, spicy foods, and hot drinks such as coffee and tea. If you have acne, continue your normal diet unless your doctor tells you otherwise.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

Azelaic acid may cause side effects. The following symptoms are likely to affect the skin you are treating with azelaic acid gel, foam, or cream. Tell your doctor if any of these symptoms are severe or do not go away: itching burning stinging tingling tenderness dryness Some side effects can be serious. If you experience any of these symptoms stop using azelaic acid and call your doctor immediately or get emergency medical treatment: swelling of the face, throat, tongue, lips, and eyes difficulty swallowing or breathing hoarseness rash hives Azelaic acid may cause other side effects. Call your doctor if you have any unusual problems while using this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze. Dispose of the gel pump and the foam 8 weeks after opening the container. Azelaic acid foam is flammable, keep it away from flames and extreme heat. Do not puncture or incinerate the azelaic acid foam container. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

The content on this page is for informational and educational purposes only and does not constitute professional medical advice. Patients should not use the information presented on this page for diagnosing a health-related issue or disease. Before taking any medication or supplements, patients should always consult a physician or qualified healthcare professional for medical advice or information about whether a drug is safe, appropriate or effective.