Azelex 20% Cream 50gm
It is used to treat pimples (acne).
Drug Class
Topical anti-acne agent; Topical anti-rosacea agent
Pharmacologic Class
Dicarboxylic acid
Pregnancy Category
Category B
FDA Approved
Dec 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Azelaic acid cream is a topical medication used to treat acne and rosacea. It works by reducing bacteria on the skin, decreasing inflammation, and helping to normalize skin cell growth to prevent clogged pores.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If the medication gets in your eyes, rinse them with plenty of water. If eye irritation persists, consult your doctor.
Wash your hands before and after applying the medication.
Clean the affected area before application and make sure it is dry.
Use a mild soap or cleansing lotion that is free of soap for facial cleaning.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Continuing Treatment
Continue using the medication as directed, even if your symptoms improve.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
You can apply makeup after the skin has dried.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the medication in a dry place, avoiding storage in a bathroom.
Store the product on its side.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If the medication gets in your eyes, rinse them with plenty of water. If eye irritation persists, consult your doctor.
Wash your hands before and after applying the medication.
Clean the affected area before application and make sure it is dry.
Use a mild soap or cleansing lotion that is free of soap for facial cleaning.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Continuing Treatment
Continue using the medication as directed, even if your symptoms improve.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
You can apply makeup after the skin has dried.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the medication in a dry place, avoiding storage in a bathroom.
Store the product on its side.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Cleanse skin thoroughly before application.
- Apply a thin layer to the affected areas only.
- Wash hands immediately after applying the cream.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Use sunscreen and wear protective clothing when outdoors, as azelaic acid may increase sun sensitivity.
- Be patient, as it may take several weeks to see noticeable improvement.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected area twice daily (morning and evening)
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to the affected area twice daily (morning and evening) after washing and drying the skin.
rosacea:
Apply a thin layer to the affected area twice daily (morning and evening) after washing and drying the skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and effectiveness not established in pediatric patients under 12 years of age for acne vulgaris. Not established for rosacea.
Adolescent:
For acne vulgaris, generally same as adult dosing (12 years and older).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Azelaic acid is a naturally occurring dicarboxylic acid. Its exact mechanism of action in treating acne vulgaris and rosacea is not fully understood. For acne, it is thought to exert its therapeutic effect by normalizing keratinization, which reduces the formation of comedones, and by possessing antimicrobial activity against Propionibacterium acnes (now Cutibacterium acnes) and Staphylococcus epidermidis. For rosacea, it is believed to reduce inflammation by inhibiting the synthesis of pro-inflammatory cytokines and by its antioxidant properties, as well as by reducing the number of inflammatory lesions.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 4% (systemic after topical application)
Tmax:
Not well-defined for topical effect; systemic levels peak within hours (e.g., 3-5 hours)
FoodEffect:
Not applicable for topical administration
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12 hours (systemic)
Clearance:
Not available
ExcretionRoute:
Renal (primarily unchanged and as metabolites)
Unchanged:
Approximately 50% (of absorbed dose)
Pharmacodynamics
OnsetOfAction:
Improvement may be seen within 4-8 weeks
PeakEffect:
Optimal results may take several months of continuous use
DurationOfAction:
Requires continuous application for sustained effect
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
- Changes in skin color
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Skin irritation, which is common with this medication, may include burning, itching, or stinging sensations. This typically occurs during the first few weeks of treatment. If your skin irritation is severe, bothersome, or persistent, consult your doctor.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
- Changes in skin color
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Skin irritation, which is common with this medication, may include burning, itching, or stinging sensations. This typically occurs during the first few weeks of treatment. If your skin irritation is severe, bothersome, or persistent, consult your doctor.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or itching that does not subside.
- Excessive redness, dryness, or peeling of the skin.
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing).
- Unusual skin discoloration (hypopigmentation).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Please note that it may take several weeks to experience the full effects of this drug.
To avoid exacerbating your skin condition, do not use this medication more frequently than prescribed. Additionally, using other skin products concurrently with this drug may increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor to minimize potential interactions.
If you have asthma, exercise caution when using this medication, as it may worsen your condition. Monitor your asthma symptoms closely, and immediately contact your doctor if you experience any deterioration in your asthma while taking this drug.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
To avoid exacerbating your skin condition, do not use this medication more frequently than prescribed. Additionally, using other skin products concurrently with this drug may increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor to minimize potential interactions.
If you have asthma, exercise caution when using this medication, as it may worsen your condition. Monitor your asthma symptoms closely, and immediately contact your doctor if you experience any deterioration in your asthma while taking this drug.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to increased local skin irritation (e.g., severe redness, burning, peeling).
What to Do:
Discontinue use and wash the affected area. Symptomatic and supportive care for local irritation. In case of accidental ingestion, contact a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity from ingestion is also unlikely due to low absorption.
Drug Interactions
Monitoring
Routine Monitoring
Skin irritation (erythema, scaling, burning, itching)
Frequency: Daily, during initial treatment
Target: Minimal to no irritation
Action Threshold: Severe or persistent irritation may require temporary discontinuation or reduced frequency.
Symptom Monitoring
- Burning
- Stinging
- Itching
- Erythema
- Dryness
- Scaling
- Peeling
- Contact dermatitis
- Hypopigmentation (rare, especially in dark-skinned individuals)
Special Patient Groups
Pregnancy
Considered generally safe during pregnancy due to minimal systemic absorption. Pregnancy Category B (older classification).
Trimester-Specific Risks:
First Trimester:
Low risk; minimal systemic absorption limits fetal exposure.
Second Trimester:
Low risk; minimal systemic absorption limits fetal exposure.
Third Trimester:
Low risk; minimal systemic absorption limits fetal exposure.
Lactation
Considered low risk during breastfeeding. Minimal systemic absorption means very little drug is expected to pass into breast milk. Lactation Risk L3.
Infant Risk:
Low risk. Advise applying to areas where the infant will not come into direct contact with the medication, especially avoiding the breast area if breastfeeding.
Pediatric Use
Safety and effectiveness not established in pediatric patients under 12 years of age for acne vulgaris. Not established for rosacea in pediatric patients. Use in adolescents (12 years and older) for acne is generally consistent with adult dosing.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related pharmacokinetic changes are unlikely to be clinically significant.
Clinical Information
Clinical Pearls
- Patients should be advised that transient irritation (burning, stinging, itching) is common, especially during the first few weeks of treatment, and usually subsides with continued use.
- For patients with sensitive skin, it may be beneficial to start with once-daily application for the first week, then increase to twice daily as tolerated.
- Consistent use is key for efficacy; improvement may not be apparent for 4-8 weeks, and full therapeutic effect can take longer.
- Azelaic acid can be used long-term for maintenance therapy in both acne and rosacea.
- It is a good option for patients who cannot tolerate or are not responding to other topical agents, or for pregnant/breastfeeding individuals due to its low systemic absorption.
Alternative Therapies
- For Acne: Topical retinoids (e.g., tretinoin, adapalene, tazarotene), benzoyl peroxide, topical antibiotics (e.g., clindamycin, erythromycin), oral antibiotics (e.g., doxycycline, minocycline), oral isotretinoin.
- For Rosacea: Topical metronidazole, topical ivermectin, topical brimonidine, oral antibiotics (e.g., doxycycline), laser therapy.
Cost & Coverage
Average Cost:
Varies widely, typically $100 - $300+ per 50gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.