Product Elements:
Flurandrenolide flurandrenolide flurandrenolide flurandrenolide cetyl alcohol citric acid monohydrate mineral oil polyoxyl 40 stearate propylene glycol sodium citrate, unspecified form stearic acid water white to off-white
Indications and Usage:
Indications and usage flurandrenolide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
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 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 using 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, so that suppleme
Read more...ntal systemic corticosteroids are required. pediatric patients may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see pediatric use under precautions ). if irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. in the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. if a favorable response does not occur promptly, flurandrenolide cream should be discontinued until the infection has been adequately controlled.
Dosage and Administration:
Dosage and administration for moist lesions, a small quantity of the cream should be rubbed gently into the affected areas 2 or 3 times a day. therapy should be discontinued when control is achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. flurandrenolide cream should not be used with occlusive dressings unless directed by a physician. tight-fitting diapers or plastic pants may constitute occlusive dressings.
Contraindications:
Contraindications topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.
Adverse Reactions:
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 acneform eruptions hypopigmentation perioral dermatitis allergic contact dermatitis the following may occur more frequently with occlusive dressings: maceration of the skin secondary infection skin atrophy striae miliaria postmarketing adverse reactions the following adverse reactions have been identified during post approval use of flurandrenolide, usp. because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. skin : skin striae, hypersensitivity, skin atrophy, contact dermatitis and skin discoloration.
Use in Pregnancy:
Usage in pregnancy 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 for pregnant patients or in large amounts or for prolonged periods of time.
Pediatric Use:
Pediatric use pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hpa axis suppression and cushing's syndrome than do 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.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description flurandrenolide cream, usp is a potent corticosteroid intended for topical use. flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. flurandrenolide is practically insoluble in water and in ether. one gram of flurandrenolide dissolves in 72 ml of alcohol and in 10 ml of chloroform. the molecular weight of flurandrenolide is 436.52. the chemical name of flurandrenolide is pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy- 16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is c 24 h 33 fo 6 . the structure is as follows: each gram of flurandrenolide cream, usp contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. chemical structure
Clinical Pharmacology:
Clinical pharmacology flurandrenolide cream, usp is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions. the mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood. corticosteroids with anti-inflammatory activity may stabilize cellular and lysosomal membranes. there is also the suggestion that the effect on the membranes of lysosomes prevents the release of proteolytic enzymes and, thus, plays a part in reducing inflammation. 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. once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to sys
Read more...temically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. they are metabolized primarily in the liver and then excreted in the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.
Pharmacokinetics:
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. 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. they are metabolized primarily in the liver and then excreted in the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
How Supplied:
How supplied flurandrenolide cream, usp is supplied in aluminum tubes as follows: flurandrenolide cream, usp 0.05%: 120 g (ndc 51672-5301-4) keep out of reach of children. storage keep tightly closed. protect from light. store at 20° to 25°c (68° to 77°f) with excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature].
Information for Patients:
Information for the patient patients using topical corticosteroids should receive the following information and instructions: this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes. patients should be advised not to use this medication for any disorder other than that for which it was prescribed. the treated skin area should not be bandaged or otherwise covered or wrapped in order to be occlusive unless the patient is directed to do so by the physician. patients should report any signs of local adverse reactions, especially under occlusive dressing. parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a patient being treated in the diaper area, because these garments may constitute occlusive dressings. do not use flurandrenolide cream on the face, underarms, or groin areas unless directed by your physician. if no improvement is seen within 2 weeks, contact your physician. do no
Read more...t use other corticosteroid-containing products while using flurandrenolide cream without first consulting your physician.
Package Label Principal Display Panel:
Principal display panel - 120 g tube carton ndc 51672-5301-4 120 g flurandrenolide cream, usp 0.05% for external use only not for use in the eyes rx only principal display panel - 120 g tube carton