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azelaic acid (Rx)Brand and Other Names:Azelex, Finacea

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream

  • 20% (Azelex)

gel

  • 15% (Finacea)

foam

  • 15% (Finacea)

kit

  • 15% (Finacea Plus)
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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

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

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Adverse 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

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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

Avoid eyes, lips, mucous membranes

Monitor patients with dark complexion for early signs of hypopigmentation

Discontinue if skin irritation is excessive or persists

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

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Pregnancy & 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.

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Pharmacology

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

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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