Acne vulgaris (alternative agent):
Note: Reserve for patients who are not able to use a topical retinoid (Ref).
Topical: Cream 20%; foam, gel 15%: Apply a thin film to the affected area(s) twice daily, in the morning and evening; may reduce to once daily if persistent skin irritation occurs. For moderate to severe acne, may be used as part of an appropriate combination regimen (Ref). Improvement is usually seen within 4 weeks (Ref).
Rosacea: Topical: Gel 15% and foam 15%: Apply a thin layer to the affected area(s) of the face twice daily, in the morning and evening; reassess diagnosis if no improvement after 12 weeks of therapy.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
(For additional information see "Azelaic acid: Pediatric drug information")
Acne vulgaris: Children ≥12 years and Adolescents: Cream (Azelex 20%): Topical: Apply a thin film to affected area(s) twice daily, in the morning and evening; may reduce to once daily if persistent skin irritation occurs
There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely needed due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely needed due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Dermatologic: Burning sensation of skin (≤16%), stinging of skin (≤16%), tingling of skin (≤16%)
1% to 10%:
Cardiovascular: Edema (≤1%)
Dermatologic: Acne vulgaris (≤1%), contact dermatitis (≤1%), desquamation (≤5%), erythema of skin (≤2%), pruritus (1% to 6%), skin irritation (≤2%), xeroderma (≤5%)
Local: Application site pain (6%), application site pruritus (3%)
<1%:
Dermatologic: Dermatitis, local dryness of skin (application site), skin rash
Local: Application site erythema
Postmarketing:
Dermatologic: Follicular rash (keratosis pilaris), hypertrichosis, hypopigmentation, skin depigmentation (small spots), vitiligo
Genitourinary: Exacerbation of herpes labialis
Hypersensitivity: Angioedema, hypersensitivity reaction
Local: Application site rash
Ophthalmic: Eye irritation, iridocyclitis
Respiratory: Exacerbation of asthma, wheezing
Cream: Hypersensitivity to azelaic acid or any component of the formulation.
Foam: There are no contraindications listed in the manufacturer's labeling.
Gel: There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to azelaic acid or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions (eg, angioedema, dyspnea, eye swelling, facial swelling, skin reactions, urticaria) have been reported; discontinue use if signs/symptoms occur.
• Hypopigmentation: A few cases of hypopigmentation after use have been reported; monitor for changes in skin color, especially in patients with dark complexions.
• Skin irritation: Skin irritation (eg, pruritus, burning, stinging) may occur, usually during the first few weeks of therapy. Discontinue use if severe skin irritation or sensitivity occurs.
Disease-related concerns:
• Asthma: Exacerbation of asthma has been reported.
Dosage form specific issues:
• Foam: Contains flammable propellants. Avoid fire, flame and smoking during and immediately following use.
• Gel: Reassess use if no improvement is seen after 12 weeks of therapy.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Appropriate use: For external use only; not for oral, ophthalmic, or vaginal use; avoid contact with the eyes, mouth, and other mucous membranes. Use of occlusive dressings or wrappings should be avoided.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Azelex: 20% (30 g [DSC])
Azelex: 20% (30 g, 50 g) [contains benzoic acid, cetearyl alcohol, propylene glycol]
Foam, External:
Finacea: 15% (50 g) [contains benzoic acid, cetostearyl alcohol, polysorbate 80, propylene glycol]
Gel, External:
Finacea: 15% (50 g [DSC]) [contains benzoic acid, disodium edta, polysorbate 80, propylene glycol]
Generic: 15% (50 g)
May be product dependent
Cream (Azelex External)
20% (per gram): $21.29
Foam (Finacea External)
15% (per gram): $10.46
Gel (Azelaic Acid External)
15% (per gram): $7.36 - $7.45
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Finacea: 15% (5 g, 50 g) [contains benzoic acid, disodium edta, polysorbate 80, propylene glycol]
Topical: Apply a thin film and gently massage into clean, dry skin; wash hands following application. Avoid the use of occlusive dressings or wrappings. For external use only; not intended for intravaginal, ophthalmic, or oral use.
Foam, gel: Shake foam well before use. Use only mild soaps or soapless cleansing lotion for facial cleansing; avoid use of abrasives, alcoholic cleansers, astringents, peeling agents, and tinctures. Cosmetics may be applied after foam or gel has dried.
Topical: Apply a thin film and gently massage into clean, dry skin; wash hands following application. Avoid the use of occlusive dressings or wrappings. For gel and foam formulation, cosmetics may be applied after the gel has dried. Use only mild soaps or soapless cleansing lotion for facial cleansing. For foam formulation, shake well before use. Not intended for intravaginal, ophthalmic, or oral use.
Acne vulgaris (cream): Treatment of mild to moderate inflammatory acne vulgaris.
Guideline recommendations: The American Association of Dermatology (AAD) acne guidelines support azelaic acid use as an adjunctive treatment option and, in particular, recommend its use in the treatment of postinflammatory dyspigmentation (AAD [Zaenglein 2016]).
Rosacea (foam, gel): Treatment of inflammatory papules and pustules of mild to moderate rosacea.
Limitations of use: Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
None known.
There are no known significant interactions.
The amount of azelaic acid available systemically following topical administration is minimal (<4%); maternal use is not expected to result in fetal exposure.
It is not known if azelaic acid is present in breast milk.
The amount of azelaic acid available systemically following topical administration is minimal (<4%); a significant change from baseline azelaic acid levels in the milk is not expected. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
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), were avoided in clinical trials.
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 Cutibacterium acnes and Staphylococcus epidermidis. May decrease microcomedo formation.
Onset of action (cream): Within 4 weeks
Absorption: Cream: ~3% to 5% penetrates stratum corneum; up to 10% found in epidermis and dermis; 4% systemic
Metabolism: Negligible after topical application; some beta-oxidation to shorter chain dicarboxylic acids
Half-life elimination: Topical: Healthy subjects: 12 hours
Excretion: Urine (primarily as unchanged drug)
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