CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids.

OVERDOSAGE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 56.7 g. NDC 15014-0815-02NuCort TM 2% Hydrocortisone Acetatewith AloeDermatoses Soothing Lotion Net Wt ozRx OnlyGentex PharmaMadison, MS 39110. Principal Display Panel 56.7 g.

ADVERSE REACTIONS SECTION.

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 approximately 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.

CLINICAL PHARMACOLOGY SECTION.

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 usedto compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that 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 disease processes in the skin increase the percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be valuable therapeutic adjunct for treatment of resistant dermatoses. (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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS: Topical corticosteroid products are contraindicated in those patients with history of hypersensitivity to any of the components of the preparation.

DESCRIPTION SECTION.

DESCRIPTION: NuCort(R) (hydrocortisone acetate 2%) is low potency topical lotion containing:Hydrocortisone Acetate 2% in base containing: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, C12-15 Alkyl Bensoate, Camphor, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, Glycerin, Glyceryl Stearate, Menthol, PEG-7 Glyceryl Cocoate, Polysorbate 60, Purified Water, Sorbitan Stearate, Squalane and Triethanolamine NuCort(R) contains synthetic corticosteroid used as an anti-inflammatory Hydrocortisone acetate Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1mg/100mL. Chemical name: Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11)-.The structural formula of hydrocortisone acetate is:. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: Apply to affected area to times daily. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

GENERAL PRECAUTIONS SECTION.

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushings 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 large dose of potent topical steroid applied to large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by usingthe 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 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. In pediatric patients absorption may result in higher blood levels and thus more susceptibility 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 favorable response does notoccur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

GERIATRIC USE SECTION.

Geriatric Use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. NuCort(R) is supplied in 2oz. bottles (NDC 15014-0185-01, NDC 15014-0185-02). Store upright at controlled room temperature 15 30C (59 86F).

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE: NuCort lotion is topical corticosteroid and is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

INFORMATION FOR PATIENTS SECTION.

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.Do not use this medication for any disorder other than for which it has been prescribed.The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.Report any signs of local adverse reactions especially under occlusive dressings.Do not use any tight fitting diapers or plastic pants on pediatric patient being treated in the diaper area, as these garments may constitute occlusive dressings.. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.. Do not use this medication for any disorder other than for which it has been prescribed.. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.. Report any signs of local adverse reactions especially under occlusive dressings.. Do not use any tight fitting diapers or plastic pants on pediatric patient being treated in the diaper area, as these garments may constitute occlusive dressings.

LABORATORY TESTS SECTION.

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

NURSING MOTHERS SECTION.

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 deleterious effect on the infant. Caution should be exercised when any topical corticosteroids are administered to nursing woman.

PEDIATRIC USE SECTION.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-Induced HPA axis suppression and Cushings Syndrome than mature patients because of larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings 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 cortisone levels and absence of response to ACTH stimulation. Manifestations of intracranialhypertension 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.

PHARMACOKINETICS SECTION.

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 disease processes in the skin increase the percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be valuable therapeutic adjunct for treatment of resistant dermatoses. (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.

PRECAUTIONS SECTION.

PRECAUTIONS:. General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushings 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 large dose of potent topical steroid applied to large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by usingthe 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 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. In pediatric patients absorption may result in higher blood levels and thus more susceptibility 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 favorable response does notoccur 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:This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.Do not use this medication for any disorder other than for which it has been prescribed.The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.Report any signs of local adverse reactions especially under occlusive dressings.Do not use any tight fitting diapers or plastic pants on pediatric patient being treated in the diaper area, as these garments may constitute occlusive dressings.. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.. Do not use this medication for any disorder other than for which it has been prescribed.. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.. Report any signs of local adverse reactions especially under occlusive dressings.. Do not use any tight fitting diapers or plastic pants on pediatric patient being treated in the diaper area, as 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. Urinary free cortisol test. ACTH stimulation test. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids.. 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 of 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 deleterious effect on the infant. Caution should be exercised when any topical corticosteroids are administered to nursing woman.. Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-Induced HPA axis suppression and Cushings Syndrome than mature patients because of larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings 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 cortisone levels and absence of response to ACTH stimulation. Manifestations of intracranialhypertension 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.

PREGNANCY SECTION.

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 of 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.

STORAGE AND HANDLING SECTION.

Store upright at controlled room temperature 15 30C (59 86F).