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Pronunciation |
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(a
zeh LAY ik AS
id) |
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U.S. Brand
Names |
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Azelex® |
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Generic
Available |
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No |
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Pharmacological Index |
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Topical Skin Product, Acne |
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Use |
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Acne vulgaris: Topical treatment of mild to moderate inflammatory
acne vulgaris |
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Pregnancy Risk
Factor |
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B |
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Pregnancy/Breast-Feeding
Implications |
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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. |
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Contraindications |
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Known hypersensitivity to any of components |
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Warnings/Precautions |
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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. |
|
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Adverse
Reactions |
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1% to 10%:
Dermatologic: Pruritus, stinging
Local: Burning
Neuromuscular & skeletal: Paresthesia
<1%: Erythema, dryness, rash, peeling, dermatitis, contact dermatitis,
irritation |
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Mechanism of
Action |
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Exact mechanism is not known; in vitro, azelaic acid possesses
antimicrobial activity against Propionibacterium acnes and
Staphylococcus epidermidis; may decrease microcomedo
formation |
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Pharmacodynamics/Kinetics |
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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 |
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Usual Dosage |
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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. |
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Mental Health: Effects
on Mental Status |
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None reported |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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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. |
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Nursing
Implications |
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Wash hands following application |
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Dosage Forms |
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Cream: 20% (30 g) |
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