NDC 0168-0279 Amcinonide

NDC Product Code 0168-0279

NDC CODE: 0168-0279

Proprietary Name: Amcinonide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Amcinonide reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a strong corticosteroid.

NDC Code Structure

  • 0168 - E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

NDC 0168-0279-60

Package Description: 1 TUBE in 1 CARTON > 60 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Amcinonide with NDC 0168-0279 is a product labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 197328.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Labeler Code: 0168
Start Marketing Date: 04-03-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Amcinonide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx onlyNOT FOR OPHTHALMIC USE.FOR DERMATOLOGIC USE ONLY.

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.

Description:

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.Each gram of Amcinonide Ointment USP, 0.1% contains 1 mg of the active steroid amcinonide in a specially formulated base composed of Benzyl Alcohol 2%, (wt/wt) as preservative, White Petrolatum, USP, Emulsifying Wax, and Antioxidant Blend (Propylene Glycol, Butylated Hydroxyanisole, Propyl Gallate and Citric Acid). Chemically, amcinonide is: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.

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.

General 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.The products are not for ophthalmic use.

Information For Patients

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 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 those that occur under occlusive dressings.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, as these garments may constitute occlusive dressings.

Laboratory Tests

Laboratory Tests: The following tests may be helpful in evaluating the HPA-axis suppression: Urinary free-cortisol test, ACTH stimulation test.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids or their effect on fertility.Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Teratogenic Effects

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

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 Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA-axis suppression and Cushing's syndrome than mature patients because of a higher ratio of skin surface area to body weight.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 and 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 Ointment USP, 0.1% (1 mg/g) is supplied as follows:
        NDC 0168-0279-60 60 gram tubes
Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP).DO NOT FREEZE.E. FOUGERA & CO.A division ofFougeraPHARMACEUTICALS INC.Melville, New York 11747
I2279DR08/12#78

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