Dosing and uses of Azelex, Finacea (azelaic acid)
Adult dosage forms and strengths
cream
- 20% (Azelex)
geL
- 15% (Finacea)
foam
- 15% (Finacea)
kit
- 15% (Finacea Plus)
Acne Vulgaris
Azelex: Massage a thin layer into the affected areas on the face q12hr
Treatment of Inflammatory Papules and Pustules of Mild to Moderate Rosacea
Finacea: Massage a thin layer into the affected areas on the face q12hr
Administration
Cleanse affected area with mild soap or soapless cleansing lotion and pat dry before applying
Reassess if no improvement after 12 weeks of therapy
Pediatric dosage forms and strengths
Acne Vulgaris
<12 years
- Safety and efficacy not established
≥12 years
- Azelex: Massage a thin layer into the affected areas on the face q12hr
Administration
Cleanse affected area with mild soap or soapless cleansing lotion and pat dry before applying
Reassess if no improvement after 12 weeks of therapy
Azelex, Finacea (azelaic acid) adverse (side) effects
>10%
Burning/ stinging/ tingling (4-16%)
1-10%
Pruritus (1-6%)
Scaling/ dry skin/ xerosis (1-5%)
Erythema/ irritation (1-2%)
<1%
Contact dermatitis
Edema
Acne
Postmarketing Reports
Facial burning
Irritation
Iridocyclitis after accidental exposure
Warnings
Contraindications
Hypersensitivity to azelaic acid, propylene glycol or any of its components
Cautions
In case of known hypersensitivity to any component of the gel, avoid the use of gel dosage form; if hypersensitivity develops during treatment, discontinue and institute appropriate therapy
For dermatologic use only
Therapy has been reported to cause irritation of eyes; avoid contact with eyes and mucous membranes
Isolated cases of hypopigmentation reported after azelaic acid use; monitor patients with dark complexion for early signs of hypopigmentation
Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during first few weeks of treatment; if sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy
Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps and cleansers, exfoliants)
Avoid any foods and beverages that provoke erythema, flushing, and blushing (eg, alcoholic beverages, spicy food, hot drinks such as hot coffee and tea)
Report any abnormal changes in skin color to physician
Avoid use of occlusive dressings or wrappings
Wash hands after applying the cream
Consult a physician if asthma is exacerbated with therapy
Pregnancy and lactation
Pregnancy category: B
Lactation: enters breast milk; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Azelex, Finacea (azelaic acid)
Mechanism of action
Azelaic acid is an antibacterial agent that inhibits the growth of susceptible organisms (principally Propionibacterium acnes) on the surface of the skin by inhibiting protein synthesis; may also inhibit follicular keratinization, which prevents development or maintenance of comedones
Mechanism by which it interferes with pathogenic events in rosacea is unknown
Pharmacokinetics
Half-Life: 12 hours
Absorption: systemic (4%)
Metabolism: Negligible cutaneous metabolism
Excretion: Unchanged in urine
