MedPath

Fluocinolone Acetonide

Approved
Approval ID

cdc77f53-e9f6-486e-896a-069bc7ec47fd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 22, 2011

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

fluocinolone acetonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-097
Application NumberANDA088170
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 22, 2011
FDA Product Classification

INGREDIENTS (10)

fluocinolone acetonideActive
Quantity: 0.1 mg in 1 g
Code: 0CD5FD6S2M
Classification: ACTIB
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58X
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/22/2011

INDICATIONS AND USAGE

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

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 2/22/2011

CONTRAINDICATIONS

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

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 2/22/2011

PRECAUTION

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 which 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 steroid applied to a large surface area or under 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 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. Children 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.

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 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: The following tests may be helpful in evaluating 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 owomen 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, caution should be exercised when topical corticosteroids are administered to a nursing woman.

**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 children receiving topical corticosteroids. Manifestations of adrenal suppression in children 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 children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/22/2011

For Dermatologic Use Only - Not for Ophthalmic Use.

Rx Only

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Fluocinolone Acetonide - FDA Drug Approval Details