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. Nevertheless, decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

OVERDOSAGE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL 60 mL CONTAINER NDC 0168-0280-60 FOUGERA(R) AMCINONIDELOTION, 0.1%60 mL (58.8 g)NOT FOR OPHTHALMIC USE.FOR DERMATOLOGIC USE ONLY.Rx only. PACKAGE LABEL PRINCIPAL DISPLAY PANEL 60 mL CONTAINER.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:. In the clinical trials with Amcinonide Lotion, the investigators reported 4.7% incidence of side effects. In weekly acceptability evaluation, approximately 20% of the patients treated with Amcinonide Lotion or placebo reported itching, stinging, soreness, or burning at one or more of the visits.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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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

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 used to 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 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.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION:. The topical corticosteroids constitute class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Amcinonide Lotion, 0.1% contains mg of the active steroid amcinonide in white, smooth, homogeneous, opaque emulsion composed of Benzyl Alcohol 1% (wt/wt) as preservative, Emulsifying Wax, Glycerin, Isopropyl Palmitate, Purified Water, Sorbitol Solution and Polyethylene Glycol 400. Dilute Lactic Acid is used for pH adjustment, if required. Chemically, amcinonide is: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis(oxy)]-9-fluoro-11-hydroxy-, (11, 16). Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. Topical corticosteroids are generally applied to the affected area as thin film from two to three times daily depending on the severity of the condition. The lotion may be applied topically to the specified lesions, particularly to those in hairy areas, two times per day. The lotion should be rubbed into the affected area completely, and the area should be protected from washing, clothing, rubbing, etc. until the lotion is dried.Occlusive dressings may be 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.

GENERAL PRECAUTIONS SECTION.

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushings 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 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 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 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 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Amcinonide Lotion, 0.1% is supplied as follows: NDC 0168-0280-60 60 mL bottle Store at controlled room temperature 15 to 30C (59 to 86F) DO NOT FREEZE. E. FOUGERA CO.A division ofFougeraPHARMACEUTICALS INC.Melville, New York 11747 I2280CR07/1284.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE:. Topical corticosteroids are 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: 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 child being treated in the diaper area, since these garments may constitute occlusive dressings. 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 child being treated in the diaper area, since 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.

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 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.

PRECAUTIONS SECTION.

PRECAUTIONS:. General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushings 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 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 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 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 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 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 child being treated in the diaper area, since these garments may constitute occlusive dressings. 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 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 of topical corticosteroids or the effect on fertility. 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 deleterious effect on the infant. Nevertheless, 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 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 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.

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 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.

SPL UNCLASSIFIED SECTION.

NOT FOR OPHTHALMIC USE.Rx onlyFOR DERMATOLOGIC USE ONLY.