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Amcinonide: Drug information

Amcinonide: Drug information
(For additional information see "Amcinonide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • RATIO-Amcinonide [DSC];
  • TARO-Amcinonide
Pharmacologic Category
  • Corticosteroid, Topical
Dosing: Adult
Steroid-responsive dermatoses

Steroid-responsive dermatoses: Topical: Apply in a thin film 2-3 times/day. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Localized burning

Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, folliculitis, hypertrichosis, hypopigmentation, local dryness, maceration of the skin, miliaria, pruritus, skin atrophy, telangiectasia

Endocrine & metabolic: Cushing's syndrome, growth suppression (long-term use), HPA-axis suppression, hyperglycemia; these reactions occur more frequently with occlusive dressings

Infection: Secondary infection

Local: Local irritation

Contraindications

Hypersensitivity to amcinonide or any component of the formulation; use on the face, groin, or axilla

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.

• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Disease-related concerns:

• Infected/weeping lesions: Occlusive dressings should not be used in presence of infection or weeping lesions.

Special populations:

• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage Forms: US

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

Cream, External:

Generic: 0.1% (15 g [DSC], 30 g [DSC], 60 g [DSC])

Lotion, External:

Generic: 0.1% (60 mL [DSC])

Ointment, External:

Generic: 0.1% (60 g)

Generic Equivalent Available: US

Yes

Pricing: US

Ointment (Amcinonide External)

0.1% (per gram): $38.16

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. [DSC] = Discontinued product

Cream, External:

Generic: 0.1% (15 g, 30 g, 60 g)

Lotion, External:

Generic: 0.1% ([DSC])

Ointment, External:

Generic: 0.1% ([DSC])

Use: Labeled Indications

Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (high potency corticosteroid)

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).

Pregnancy Considerations

Systemic bioavailability of topical corticosteroids is variable (eg, integrity of skin, use of occlusion) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).

When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).

Breastfeeding Considerations

It is not known if topical application will result in detectable quantities in breast milk. However, systemic corticosteroids are excreted in human milk.

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. Topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).

Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding, then clean nipples prior to the next feeding (Vestergaard 2019)

Mechanism of Action

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Amcinonide has high potency.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Adequate through intact skin; increases with skin inflammation or occlusion

Metabolism: Hepatic

Excretion: Urine and feces

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

  • (AR) Argentina: Visderm;
  • (BE) Belgium: Amicla;
  • (DE) Germany: Amciderm;
  • (EC) Ecuador: Visderm;
  • (FR) France: Penticort;
  • (JP) Japan: Coupe am;
  • (KR) Korea, Republic of: Visderm;
  • (LU) Luxembourg: Amicla;
  • (MX) Mexico: Visderm h;
  • (PK) Pakistan: Cyclocort;
  • (PR) Puerto Rico: Cyclocort;
  • (TH) Thailand: Amciderm | Visderm;
  • (TW) Taiwan: Saugea | Visderm
  1. Amcinonide cream [prescribing information]. Melville, NY: Fougera Pharmaceuticals; March 2020.
  2. Amcinonide ointment [prescribing information]. Melville, NY: Fougera Pharmaceuticals; April 2014.
  3. Andersson NW, Skov L, Andersen JT. Evaluation of topical corticosteroid use in pregnancy and risk of newborns being small for gestational age and having low birth weight. JAMA Dermatol. 2021;157(7):788-795. doi:10.1001/jamadermatol.2021.1090 [PubMed 33950165]
  4. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.e1-10. doi:10.1016/j.jaad.2013.09.009 [PubMed 24528912]
  5. Chi CC, Wang SH, Wojnarowska F, Kirtschig G, Davies E, Bennett C. Safety of topical corticosteroids in pregnancy. Cochrane Database Syst Rev. 2015;(10):CD007346. doi:10.1002/14651858.CD007346.pub3 [PubMed 26497573]
  6. Chi CC, Kirtschig G, Aberer W, et al. Updated evidence-based (S2e) European Dermatology Forum guideline on topical corticosteroids in pregnancy. J Eur Acad Dermatol Venereol. 2017;31(5):761-773. doi:10.1111/jdv.14101 [PubMed 28233354]
  7. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470. doi:10.1016/j.jaad.2020.07.087 [PubMed 32738429]
  8. Goedert JJ, Vitale F, Lauria C, et al. Risk Factors for Classical Kaposi's Sarcoma. J Natl Cancer Inst. 2002;94(22):1712-1718. [PubMed 12441327]
  9. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24(2):167-197, vi. doi:10.1016/j.det.2006.01.001 [PubMed 16677965]
  10. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  11. Oakley R, Arents BWM, Lawton S, Danby S, Surber C. Topical corticosteroid vehicle composition and implications for clinical practice. Clin Exp Dermatol. 2021;46(2):259-269. doi:10.1111/ced.14473 [PubMed 33108015]
  12. Stacey SK, McEleney M. Topical corticosteroids: choice and application. Am Fam Physician. 2021;103(6):337-343. [PubMed 33719380]
  13. Tadicherla S, Ross K, Shenefelt PD, Fenske NA. Topical corticosteroids in dermatology. J Drugs Dermatol. 2009;8(12):1093-1105. [PubMed 20027937]
  14. Vestergaard C, Wollenberg A, Barbarot S, et al. European task force on atopic dermatitis position paper: treatment of parental atopic dermatitis during preconception, pregnancy and lactation period. J Eur Acad Dermatol Venereol. 2019;33(9):1644-1659. doi:10.1111/jdv.15709 [PubMed 31231864]
  15. World Health Organization (WHO); UNICEF. Breastfeeding and maternal medication. Recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. https://apps.who.int/iris/handle/10665/62435.
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