Adult Dosing

Mild-to-moderate inflammatory acne vulgaris

• Apply 20% cream on affected areas bid

Rosacea

• Apply 15% Gel on affected areas bid; reassess if no improvement is observed in 12wks

Note:

• Avoid occlusive dressings

Pediatric Dosing

• Safety and effectiveness of cream, in pediatric patients under 12 years of age have not been established

Mild-to-moderate inflammatory acne vulgaris

• >12 yrs
• Apply 20% cream on affected areas bid

Note:

• Avoid occlusive dressings
• Safety and effectiveness of gel, in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Mild-to-moderate inflammatory acne vulgaris (Azelex Cream)
• Inflammatory papules and pustules of mild to moderate rosacea (Finacea Gel)

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to propylene glycol

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• For dermatologic use only and not for ophthalmic use
• Hypopigmentation has been reported with the use of azelaic acid; monitor patients for early signs of hypopigmentation
• Discontinue the therapy if sensitivity or severe irritation develop
• Temporary skin irritation such as pruritus, burning, or stinging have been reported when azelaic acid is applied to broken or inflamed skin, at the start of treatment; discontinue the therapy if such reactions develop and consult their physician
• Caution in lentigo maligna as may progress to malignant melanoma

Caution: Use cautiously in

• Dark complexion

Supplemental Patient Information

• Avoid use of occlusive dressings or wrappings
• Advise patient to keep azelaic acid away from mouth, eyes and other mucous membranes

Pregnancy Category:B

Breastfeeding: Since 4% of a dose is absorbed after topical application and it is a chemical that appears in foods and the bloodstream normally, azelaic acid is considered a low risk to the nursing infant. Avoid infant's skin to come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 5 May 2011). Manufacturer recommends use with caution in nursing woman.

• DERM: Burning, stinging, tingling, dryness, tightness, scaling, itching, erythema, irritation, pruritus, redness, hypopigmentation, vitiligo depigmentation, hypertrichosis
• RESP: Asthma exacerbation
• MISC: Herpes labialis

• Antibiotic agent; exact mechanism of action is unknown; however, it inhibits the synthesis of cellular protein in anaerobic and aerobic bacteria
• Systemic absorption (4%) following topical application
• Metabolized by skin; CYP450: Unknown
• Excreted in urine
• Half-life: 12 hrs

US Trade Name(s)

• Azelex
• Finacea

US Availability

Azelex

• CRE: 20%

Finacea

• GEL: 15%

Canadian Trade Name(s)

• Finacea

Canadian Availability

Finacea

• GEL: 15%

UK Trade Name(s)

• Finacea
• Skinoren

UK Availability

Finacea

• GEL: 15%

Skinoren

• CRE: 20%

Australian Trade Name(s)

• Acnederm Medicated Lotion
• Finacea

Australian Availability

Acnederm Medicated Lotion

• LOTN: 25 g

Finacea

• GEL: 15%

[Outline]

Dermatologic

Dermatologic Topical Agents

Anti-Acne Agents

Pricing data from www.DrugStore.com in U.S.A.

• Azelex 20 % CREA [Tube] (ALLERGAN DERMATOLOGICS)
  50 % = $292.98
  150 % = $833.94
• Finacea 15 % GEL [Tube] (INTENDIS)
  50 % = $178.49
  150 % = $499.96
• Azelex 20 % CREA [Tube] (ALLERGAN DERMATOLOGICS)
  30 % = $196
  90 % = $557.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.