ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Azelaic acid: Drug information

Azelaic acid: Drug information
(For additional information see "Azelaic acid: Patient drug information" and see "Azelaic acid: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Azelex;
  • Finacea
Brand Names: Canada
  • Finacea
Pharmacologic Category
  • Topical Skin Product, Acne
Dosing: Adult
Acne vulgaris

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

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.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Azelaic acid: Pediatric drug information")

Acne vulgaris

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

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Adverse Reactions

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

Contraindications

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.

Warnings/Precautions

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.

Warnings: Additional Pediatric Considerations

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).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Azelex: 20% (30 g [DSC], 50 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)

Generic Equivalent Available: US

May be product dependent

Pricing: US

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.

Dosage Forms: Canada

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]

Administration: Adult

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.

Administration: Pediatric

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.

Use: Labeled Indications

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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

The amount of azelaic acid available systemically following topical administration is minimal (<4%); maternal use is not expected to result in fetal exposure.

Breastfeeding Considerations

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.

Dietary Considerations

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.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Skinoren;
  • (AR) Argentina: Cutacelan;
  • (AT) Austria: Skinoren;
  • (AU) Australia: Finacea | Skinoren;
  • (BD) Bangladesh: Azelec;
  • (BE) Belgium: Skinoren;
  • (BG) Bulgaria: Skinoren;
  • (BR) Brazil: Azelan | Dermazelaic | Dermizan;
  • (CH) Switzerland: Skinoren;
  • (CO) Colombia: Cutacelan | Finacea | Rozelaic;
  • (CZ) Czech Republic: Aknoren | Skinoren;
  • (DE) Germany: Acmed | Skinoren;
  • (DO) Dominican Republic: Azelac | Cutacelan;
  • (EC) Ecuador: Cutacelan;
  • (EE) Estonia: Finacea | Skinoren;
  • (EG) Egypt: Azaderm | Azeclear | Skinoren;
  • (ES) Spain: Finacea | Skinoren | Zelaika | Zeliderm;
  • (ET) Ethiopia: Skinoren;
  • (FI) Finland: Skinoren;
  • (FR) France: Finacea | Skinoren;
  • (GB) United Kingdom: Finacea | Skinoren;
  • (GR) Greece: Alenzantyl | Arbonid | Azelderm | Cevigen | Chemilaic | Exazen | Forcilen | Kenedril | Noreskin | Opilet | Prevolac | Skinoren | Sonalent | Zelicrema | Zumilin;
  • (HK) Hong Kong: Azeclear | Azelderm | Skinoren;
  • (HR) Croatia: Skinoren;
  • (HU) Hungary: Finacea | Skinoren;
  • (ID) Indonesia: Aza | Skinoren | Zelface | Zeliris;
  • (IE) Ireland: Skinoren;
  • (IL) Israel: Skinoderm;
  • (IN) India: Aziderm | Dermac | Exazel | Ezanic | Picspot;
  • (IS) Iceland: Skinoren;
  • (IT) Italy: Acnezaic | Finacea | Skinoren;
  • (JO) Jordan: Azeclear | Azelderm | Skinoren;
  • (KR) Korea, Republic of: Acnes | Azalea | Azealin | Diola | Nabilena | Neatman | Umona;
  • (KW) Kuwait: Skinoren;
  • (LB) Lebanon: Skinoren;
  • (LT) Lithuania: Aziderm | Finacea | Skinoren;
  • (LU) Luxembourg: Skinoren;
  • (LV) Latvia: Finacea | Skinoren;
  • (MA) Morocco: Skinoren;
  • (MX) Mexico: Cutacelan | Finacea;
  • (MY) Malaysia: Skinoren;
  • (NO) Norway: Finacea | Skinoren;
  • (NZ) New Zealand: Skinoren;
  • (PE) Peru: Cutacelan;
  • (PH) Philippines: Skinoren;
  • (PK) Pakistan: Acneaid | Acnesafe | Azelexin | Hasko derm | Skinex | Skinoren;
  • (PL) Poland: Acne derm | Finacea | Hascoderm | Hascoderm lipozel | Skinoren;
  • (PR) Puerto Rico: Azelex | Finacea | Finevin;
  • (PT) Portugal: Ac.azelaico | Acido azelaico | Finacea | Skinoren;
  • (QA) Qatar: Skinoren;
  • (RU) Russian Federation: Azelic | Aziks derm | Azix derm | Skinoclear | Skinoren;
  • (SA) Saudi Arabia: Skinoren;
  • (SE) Sweden: Finacea | Skinoren;
  • (SG) Singapore: Skinoren;
  • (SI) Slovenia: Skinoren;
  • (SK) Slovakia: Finacea | Skinoren;
  • (TH) Thailand: Skinoren | Wl;
  • (TR) Turkey: Azelderm | Finacea | Skinoren;
  • (TW) Taiwan: Azeic-a | Azel | Azelderm | Kando | Leo | Onepass | Skinoren | Za;
  • (UA) Ukraine: Acnestop | Azogel | Skinoren;
  • (UY) Uruguay: Rozelaic;
  • (VE) Venezuela, Bolivarian Republic of: Cutacelan;
  • (ZA) South Africa: Skinoren
  1. Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  3. Azelex (azelaic acid) [prescribing information]. Exton, PA: Almirall, LLC; June 2019.
  4. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm [PubMed 6423951]
  5. Finacea (azelaic acid) foam [prescribing information]. Madison, NJ: LEO Pharma Inc; December 2020.
  6. Finacea (azelaic acid) gel [prescribing information]. Madison, NJ: LEO Pharma Inc; May 2021.
  7. Finacea (azelaic acid) gel [prescribing information]. Madison, NJ: LEO Pharma Inc; November 2021.
  8. Finacea (azelaic acid) gel [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; September 2019.
  9. Graber E. Acne vulgaris: Management of moderate to severe acne in adolescents and adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 3, 2022a.
  10. Graber E. Acne vulgaris: overview of management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 3, 2022b.
  11. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  12. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  13. Refer to manufacturer's labeling.
  14. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  15. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  16. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33. http://www.jaad.org/article/S0190-9622(15)02614-6/pdf. Accessed March 3, 2022. [PubMed 26897386]
Topic 9038 Version 238.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟