|
This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or
standards of non-Merck sources.
Pronunciation
(a zeh LAY ik AS id)
U.S. Brand Names
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Topical treatment of inflammatory papules and pustules of mild-to-moderate rosacea; mild-to-moderate inflammatory acne vulgaris
Finacea®: Not FDA-approved for the treatment of acne
Pregnancy Risk Factor
B
Lactation
Enters breast milk/use caution
Breast-Feeding Considerations
Since <4% of a topically applied dose is systemically absorbed, the uptake of azelaic acid into breast milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, exercise caution when administering to a nursing mother.
Contraindications
Hypersensitivity to azelaic acid or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Hypopigmentation: There have been isolated reports of hypopigmentation after use.
• Skin irritation: If sensitivity or severe irritation develops, discontinue treatment and institute appropriate therapy.
Special populations:
• Pediatrics: Safety and efficacy have not been established in children <12 years of age.
Dosage form specific issues:
• Gel: Use of gel beyond 12 weeks has not been studied.
Other warnings/precautions:
• Appropriate use: For external use only; not for ophthalmic or vaginal use. Use of occlusive dressings or wrappings should be avoided.
Adverse Reactions
>5%: Dermatologic: Pruritus (1% to 6%), burning/stinging/itching (1% to 6%)
1% to 5%:
Dermatologic: Acne (<1% to 1%), edema, erythema, rash, peeling, dermatitis, contact dermatitis, irritation, scaling/dry skin/xerosis
Neuromuscular & skeletal: Paresthesia
Postmarketing and/or case reports: Asthma exacerbation, herpes labialis exacerbation, hypertrichosis, reddening, small depigmented spots, vitiligo depigmentation
Drug Interactions
There are no known significant interactions.
Storage
Store between 15°C to 30°C (59°F to 86°F).
Mechanism of Action
Azelaic acid is a dietary constituent normally found in whole grain cereals; can be formed endogenously. Exact mechanism is not known. In vitro, azelaic acid possesses antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. May decrease microcomedo formation.
Pharmacodynamics/Kinetics
Absorption: Cream: ~3% to 5% penetrates stratum corneum; up to 10% found in epidermis and dermis; 4% systemic
Half-life elimination: Topical: Healthy subjects: 12 hours
Excretion: Urine (as unchanged drug)
Dosage
Topical:
Adolescents ?12 years and Adults: Acne vulgaris: Cream 20%: After skin is thoroughly washed and patted dry, gently but thoroughly massage a thin film of azelaic acid cream into the affected areas twice daily, in the morning and evening. The duration of use can vary and depends on the severity of the acne. In the majority of patients with inflammatory lesions, improvement of the condition occurs within 4 weeks.
Adults: Rosacea: Gel 15%: Massage gently into affected areas of the face twice daily; use beyond 12 weeks has not been studied
Administration: Topical
Apply to clean, dry skin; wash hands following application. Avoid the use of occlusive dressings or wrappings. For gel formulation, cosmetics may be applied after the gel has dried. Not to be used orally, intravaginally, or for the eyes.
Dietary Considerations
Gel: Foods and beverages that might provoke erythema, flushing, and blushing, such as spicy food, alcoholic beverages, and thermally hot drinks (including hot coffee and tea), should be avoided.
Patient Education
This medication is for application to affected skin areas only; as per directions of prescriber. Use for full prescribed treatment period. Do not apply any other skin products without consulting prescriber; especially avoid alcoholic cleansers, tinctures, and astringents; abrasives and peeling agents. Temporary skin irritation (eg pruritus, burning, stinging) may occur when applied to broken or inflamed skin, usually at start of treatment. If irritation continues, apply only once a day or stop treatment until these effects have subsided. If irritation reoccurs with further use, discontinue and consult prescriber. If you have dark skin, report immediately any complexion changes or loss of color. Breast-feeding precaution: Consult prescriber if you are breast-feeding.
Application: Apply with gloves and wash hands following application. Do not allow medication to come into contact with eyes, mouth, or mucous membranes (if it does come into contact with eyes, wash with large amount of water and consult prescriber if eye irritation persists). Apply nonirritating cosmetics after gel has dried.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Assess therapeutic effectiveness and adverse response (sensitivity, severe irritation, or hypopigmentation in dark skinned patients) at regular intervals during therapy. Teach patient proper use, possible side effects/appropriate interventions, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream:
Azelex®: 20% (30 g, 50 g) [contains benzoic acid]
Gel:
Finacea®: 15% (50 g) [contains benzoic acid]
Finacea® Plus™: 15% (50 g) [contains benzoic acid]
Pricing: U.S. (www.drugstore.com)
Cream (Azelex)
20% (30): $123.79
20% (50): $179.38
Gel (Finacea)
15% (50): $134.29
International Brand Names
Lexi-Comp.com
Last full review/revision August 2009
Content last modified August 2009
| 
