Amcinonide

Name: Amcinonide

Warnings

Included as part of the "PRECAUTIONS" Section

Dosing & Uses

Dosage Forms & Strengths

cream/ointment/lotion

  • 0.1%

Corticosteroid-Responsive Dermatoses

Applied sparingly in a thin film to the affected area q8-12hr

Dosage Forms & Strengths

cream/ointment/lotion

  • 0.1%

Corticosteroid-Responsive Dermatoses

Apply sparingly to affected area(s) q12hr

Limit to minimum amount necessary for therapeutic efficacy

Avoid face

Adverse Effects

Frequency Not Defined

Skin atrophy

Striae

Burning

Dryness

Irritation

Itching

Hypertrichosis

Acneform lesions

Secondary infection

Pigmentation changes

HPA suppression (with higher potency used >2 wk)

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Amcinonide Dosage

Take amcinonide exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Amcinonide dose your doctor recommends will be based on the following (use any or all that apply):

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

Amcinonide is available in the following doses:

  • Amcinonide Topical 0.1% Topical Cream
  • Amcinonide Topical 0.1% Topical Lotion
  • Amcinonide Topical 0.1% Topical Ointment

Package label - principal display panel - 15 gram carton

NDC 0168-0278-15

Rx Only

Fougera®

Amcinonide
CREAM USP, 0.1%

NOT FOR OPHTHALMIC USE.
FOR DERMATOLOGIC USE ONLY.

WARNING: Keep out of
reach of children.

NET WT 15 grams

Amcinonide 
Amcinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0168-0278
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amcinonide (Amcinonide) Amcinonide 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
water  
sorbitol  
lactic acid  
glycerin  
isopropyl palmitate  
benzyl alcohol  
Packaging
# Item Code Package Description
1 NDC:0168-0278-15 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:0168-0278-30 1 TUBE in 1 CARTON
2 30 g in 1 TUBE
3 NDC:0168-0278-60 1 TUBE in 1 CARTON
3 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076065 05/15/2003
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
Revised: 07/2013   E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Adverse Reactions

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

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.

Side effects

Post-Market Adverse Drug Reactions

The following adverse reactions are reported when topical corticosteroids are used as recommended. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.

Endocrine Disorders

Hypothalamic-pituitary adrenal (HPA) axis suppression, cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, hyperglycemia/glucosuria, hypertension, increased weight/obesity, decreased endogenous cortisol levels, steroid withdrawal syndrome

Eye Disorders

glaucoma, cataract subcapsular

Gastrointestinal Disorders

upper abdominal pain

General Disorders And Administration Site Conditions

Application site irritation/pain.

Immune System Disorders

local hypersensitivity (see Skin And Subcutaneous Tissue Disorders)

Infections And Infestations

secondary infection

Investigations

Decreased glucose tolerance has also been reported

Skin And Subcutaneous Tissue Disorders

skin striae, skin atrophy, telangiectasia, purpura-like bleeding, acne, dermatitis, hypertrichosis, skin depigmentation, erythema, burning sensation, pruritus, eczema, dryness, itching, local irritation, atrophy of the subcutaneous tissues, pustules, miliaria, folliculitis, pyoderma, allergic contact dermatitis, acneiform eruptions, perioral dermatitis, rash, urticaria, pustular psoriasis, skin wrinkling, alopecia, trichorrhexis, skin infection.

Vascular Disorders

thrombosis

Read the entire FDA prescribing information for Cyclocort (amcinonide)

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© Cyclocort Patient Information is supplied by Cerner Multum, Inc. and Cyclocort Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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