Label: AMCINONIDE cream
AMCINONIDE ointment

  • NDC Code(s): 51672-4054-1, 51672-4054-2, 51672-4054-3, 51672-4054-4, view more
    51672-4060-1, 51672-4060-2, 51672-4060-3
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 24, 2020

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  • SPL UNCLASSIFIED SECTION

    Rx only.

  • DESCRIPTION

    The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

    TOPICAL CREAM USP, 0.1%

    Each gram of Amcinonide Cream contains 1 mg of the active steroid amcinonide in a white, smooth, homogeneous, opaque emulsion composed of benzyl alcohol (as preservative), emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water and sorbitol solution 70%.

    TOPICAL OINTMENT USP, 0.1%

    Each gram of Amcinonide Ointment contains 1 mg of the active steroid amcinonide in a specially formulated base composed of benzyl alcohol 2.2% (wt/wt) as preservative, butylated hydroxyanisole, citric acid anhydrous, emulsifying wax, propyl gallate, propylene glycol, and white petrolatum.

    Chemically, amcinonide is:

    Chemical Structure

    Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis (oxy)]-9-fluoro-11-hydroxy-, (11β, 16α).

  • CLINICAL PHARMACOLOGY

    Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

    The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

    Pharmacokinetics

    The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

    Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).

    Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.

    Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

  • INDICATIONS AND USAGE

    Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

  • CONTRAINDICATIONS

    Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

  • PRECAUTIONS

    General

    Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.

    Conditions that augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute with a less potent steroid.

    Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

    Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

    Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS Pediatric Use).

    If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

    In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

    These products are not for ophthalmic use.

    Information for the Patient

    Patients using topical corticosteroids should receive the following information and instructions:

    1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
    2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
    3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
    4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
    5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area since these garments may constitute occlusive dressings.

    Laboratory Tests

    The following tests may be helpful in evaluating the HPA axis suppression:

    Urinary free cortisol test
    ACTH stimulation test

    Carcinogenesis, Mutagenesis, and Impairment of Fertility

    Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

    Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

    Pregnancy Category C

    Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

    Nursing Mothers

    It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

    Pediatric Use

    Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

    Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

    Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

  • ADVERSE REACTIONS

    The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

     
    Burning
     
    Itching
     
    Irritation
     
    Dryness
     
    Folliculitis
     
    Hypertrichosis
     
    Acneiform eruptions
     
    Hypopigmentation
     
    Perioral dermatitis
     
    Allergic contact dermatitis
     
    Maceration of the skin
     
    Secondary infection
     
    Skin atrophy
     
    Striae
     
    Miliaria
  • OVERDOSAGE

    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

  • DOSAGE AND ADMINISTRATION

    Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition.

    Occlusive dressings may be a valuable therapeutic adjunct for the management of psoriasis or recalcitrant conditions.

    If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

  • HOW SUPPLIED

    Amcinonide Topical Cream USP, 0.1% (1 mg/g) is supplied in 4 gm, 15 gm, 30 gm and 60 gm tubes.

    Amcinonide Topical Ointment USP, 0.1% (1 mg/g) is supplied in 15 gm, 30 gm and 60 gm tubes.

    Store at 20° -25°C (68°-77°F) [see USP Controlled Room Temperature]

    DO NOT FREEZE.

  • SPL UNCLASSIFIED SECTION

    Mfd. By: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110

    Revised: February, 2010
    90056-0210-5 291

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    NDC 51672-4054-2

    30 g

    Amcinonide
    Cream USP, 0.1%

    FOR DERMATOLOGIC USE ONLY.

    NOT FOR OPHTHALMIC USE.

    Rx only

    TARO

    Keep this and all medications out of the reach of children.

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    NDC 51672-4060-2

    30 g

    Amcinonide
    Ointment USP, 0.1%

    FOR DERMATOLOGIC USE ONLY.

    NOT FOR OPHTHALMIC USE.

    Rx only

    TARO

    Keep this and all medications out of the reach of children.

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    AMCINONIDE 
    amcinonide cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51672-4054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amcinonide (UNII: 423W026MA9) (Amcinonide - UNII:423W026MA9) Amcinonide1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    glycerin (UNII: PDC6A3C0OX)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-4054-41 in 1 CARTON05/31/2002
    14 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-4054-11 in 1 CARTON05/31/2002
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51672-4054-21 in 1 CARTON05/31/2002
    330 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:51672-4054-31 in 1 CARTON05/31/2002
    460 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07622905/31/2002
    AMCINONIDE 
    amcinonide ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51672-4060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amcinonide (UNII: 423W026MA9) (Amcinonide - UNII:423W026MA9) Amcinonide1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    butylated hydroxyanisole (UNII: REK4960K2U)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    propyl gallate (UNII: 8D4SNN7V92)  
    propylene glycol (UNII: 6DC9Q167V3)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-4060-11 in 1 CARTON03/19/2003
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-4060-21 in 1 CARTON03/19/2003
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51672-4060-31 in 1 CARTON03/19/2003
    360 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07636703/19/2003
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(51672-4054, 51672-4060)