Included as part of the "PRECAUTIONS" Section
Dosing & Uses
Dosage Forms & Strengths
Applied sparingly in a thin film to the affected area q8-12hr
Dosage Forms & Strengths
Apply sparingly to affected area(s) q12hr
Limit to minimum amount necessary for therapeutic efficacy
Frequency Not Defined
HPA suppression (with higher potency used >2 wk)
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
CREAM USP, 0.1%
NOT FOR OPHTHALMIC USE.
FOR DERMATOLOGIC USE ONLY.
WARNING: Keep out of
reach of children.
NET WT 15 grams
|Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)|
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
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.
• Infected/weeping lesions: Occlusive dressings should not be used in presence of infection or weeping lesions.
• 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.
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 syndromeEye Disorders
glaucoma, cataract subcapsularGastrointestinal Disorders
upper abdominal painGeneral Disorders And Administration Site Conditions
Application site irritation/pain.Immune System Disorders
local hypersensitivity (see Skin And Subcutaneous Tissue Disorders)Infections And Infestations
Decreased glucose tolerance has also been reportedSkin 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
Read the entire FDA prescribing information for Cyclocort (amcinonide)Read More »
- Cutivate Lotion
- Cutivate Ointment
- Diprolene AF
- Diprolene Lotion
- Diprolene Ointment
- Lac-Hydrin Cream
© 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.