Azelex 20% Cream 30gm
It is used to treat pimples (acne).
Drug Class
Topical anti-acne agent
Pharmacologic Class
Dicarboxylic acid
Pregnancy Category
Category B
FDA Approved
Mar 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Azelaic acid cream is a topical medication used to treat acne. It works by helping to clear up pimples and blackheads, and by reducing inflammation and bacteria on the skin.
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. 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 use and dry it thoroughly.
For facial cleaning, use only mild, soap-free soaps or cleansing lotions.
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 your doctor instructs you to do so.
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. 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 use and dry it thoroughly.
For facial cleaning, use only mild, soap-free soaps or cleansing lotions.
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 your doctor instructs you to do so.
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
- Wash and dry the affected skin thoroughly before applying the cream.
- Apply a thin layer of cream to the entire affected area, not just individual pimples.
- Gently massage the cream into the skin.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Use sunscreen and protective clothing when outdoors, as azelaic acid may increase sensitivity to the sun.
- Be patient; it may take 4 weeks or longer to see noticeable improvement.
- Do not use occlusive dressings or bandages over the treated area.
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. Gently massage into the skin. Improvement is usually seen within 4 weeks, but treatment may be continued for several months if necessary.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
Safety and effectiveness have not been established in pediatric patients under 12 years of age. For adolescents 12 years and older, dosing is generally similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
The exact mechanism of action of azelaic acid in the treatment of acne vulgaris is not known. It is thought to exert its therapeutic effect by normalizing keratinization, which reduces the formation of comedones. It also possesses antimicrobial activity against Propionibacterium acnes (now Cutibacterium acnes) and Staphylococcus epidermidis. Additionally, it has anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 4% (systemic absorption after topical application)
Tmax:
Not well-defined for topical application, but systemic peak levels are very low.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined due to minimal systemic absorption.
ProteinBinding:
Not well-defined due to minimal systemic absorption.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 45 minutes (systemic, after absorption)
Clearance:
Not well-defined due to minimal systemic absorption.
ExcretionRoute:
Primarily renal excretion of unchanged and metabolized drug.
Unchanged:
Approximately 4% of topically applied dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Clinical improvement usually seen within 4 weeks.
PeakEffect:
Continued improvement over several months of treatment.
DurationOfAction:
Maintained with continued use.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Change in skin color
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
* Skin irritation, which may include:
+ Burning
+ Itching
+ Stinging
+ Redness
+ Swelling
Skin irritation is common with this medication, especially during the first few weeks of treatment. If your skin irritation is severe, bothersome, or persistent, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Change in skin color
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
* Skin irritation, which may include:
+ Burning
+ Itching
+ Stinging
+ Redness
+ Swelling
Skin irritation is common with this medication, especially during the first few weeks of treatment. If your skin irritation is severe, bothersome, or persistent, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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 such as rash, hives, swelling of the face/lips/tongue, or difficulty breathing.
- Noticeable lightening of skin color (hypopigmentation), especially in individuals with dark complexions.
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
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, as this may worsen your skin problem. Additionally, using other skin products concurrently with this drug can 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 asthma symptoms in some individuals. 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, notify 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, as this may worsen your skin problem. Additionally, using other skin products concurrently with this drug can 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 asthma symptoms in some individuals. 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, notify 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 local irritation (e.g., severe burning, stinging, redness, peeling).
What to Do:
Discontinue use and wash the area with water. Symptomatic and supportive care for local irritation. Call 1-800-222-1222 (Poison Control) if accidental ingestion occurs, though systemic toxicity from ingestion is also unlikely due to low toxicity profile.
Drug Interactions
Monitoring
Symptom Monitoring
- Skin irritation (e.g., burning, stinging, itching, redness, dryness, peeling)
- Hypopigmentation (especially in patients with dark complexions)
- Allergic reactions (e.g., rash, swelling, difficulty breathing)
Special Patient Groups
Pregnancy
Azelaic acid is classified as Pregnancy Category B. Animal studies have shown no evidence of harm to the fetus at doses much higher than those achieved with topical application in humans. Due to minimal systemic absorption, the risk to the fetus is considered low.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Azelaic acid is considered L3 (Moderately safe) for lactation. It is naturally present in human milk, and systemic absorption from topical application is minimal. Therefore, the amount transferred to breast milk is expected to be very low. Use with caution, and avoid applying to areas where the infant may ingest the cream.
Infant Risk:
Low risk due to minimal systemic absorption and natural presence in human milk.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 12 years of age for acne vulgaris. For adolescents 12 years and older, the safety and efficacy profile is similar to adults.
Geriatric Use
No specific dosage 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 differences in pharmacokinetics are not expected to be clinically significant.
Clinical Information
Clinical Pearls
- Patients should be advised that transient irritation (e.g., burning, stinging, itching) may occur, especially during the initial weeks of treatment. This usually subsides with continued use.
- Improvement in acne typically occurs gradually over several weeks. Patients should be encouraged to continue treatment as prescribed.
- Azelaic acid can cause hypopigmentation in some individuals, particularly those with darker skin tones. Patients should be monitored for this effect.
- Sun protection (sunscreen, protective clothing) is important during treatment, as azelaic acid may increase skin sensitivity to UV light.
- Azelex 20% Cream is specifically indicated for acne vulgaris. Finacea (azelaic acid 15% gel/foam) is indicated for rosacea.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Benzoyl peroxide
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Salicylic acid
- Dapsone (topical)
Cost & Coverage
Average Cost:
Varies widely per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 (for 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.