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Azelaic Acid
Pronunciation
U.S. Brand Names
Generic Available
Pharmacological Index
Use
Pregnancy Risk Factor
Pregnancy/Breast-Feeding Implications
Contraindications
Warnings/Precautions
Adverse Reactions
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Mental Health: Effects on Mental Status
Mental Health: Effects on Psychiatric Treatment
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Nursing Implications
Dosage Forms

Pronunciation
(a zeh LAY ik AS id)

U.S. Brand Names
Azelex®

Generic Available

No


Pharmacological Index

Topical Skin Product, Acne


Use

Acne vulgaris: Topical treatment of mild to moderate inflammatory acne vulgaris


Pregnancy Risk Factor

B


Pregnancy/Breast-Feeding Implications

Breast-feeding/lactation: 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

Known hypersensitivity to any of components


Warnings/Precautions

For external use only; not for ophthalmic use; there have been isolated reports of hypopigmentation after use. If sensitivity or severe irritation develops, discontinue treatment and institute appropriate therapy.


Adverse Reactions

1% to 10%:

Dermatologic: Pruritus, stinging

Local: Burning

Neuromuscular & skeletal: Paresthesia

<1%: Erythema, dryness, rash, peeling, dermatitis, contact dermatitis, irritation


Mechanism of Action

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: ~3% to 5% penetrates the stratum corneum; up to 10% is found in the epidermis and dermis; 4% is systemically absorbed

Half-life: Healthy subjects: 12 hours after topical dosing

Elimination: Mainly excreted unchanged in the urine


Usual Dosage

Adults: Topical: 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.


Mental Health: Effects on Mental Status

None reported


Mental Health: Effects on Psychiatric Treatment

None reported


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

No effects or complications reported


Patient Information

Apply with gloves and wash hands following application. Use for the full prescribed treatment period. Avoid the use of occlusive dressings or wrappings. Keep away from the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, wash eyes with large amounts of water and consult prescriber if eye irritation persists. Patients with dark complexion should report changes in skin color. Temporary skin irritation (eg, pruritus, burning or stinging) may occur when azelaic acid is applied to broken or inflamed skin, usually at the start of treatment. However, this irritation commonly subsides if treatment is continued. If it continues, apply only once a day, or stop the treatment until these effects have subsided. If irritation persists, discontinue use and consult prescriber. Breast-feeding precautions: Consult prescriber if breast-feeding.


Nursing Implications

Wash hands following application


Dosage Forms

Cream: 20% (30 g)


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