Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
ECR Pharmaceuticals
ORAL
PRESCRIPTION DRUG
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in a
Dexamethasone tablets, USP 1.5 mg are scored, pink, pentagonal-shaped tablets debossed “ECR” score “86” on one side and plain on the other side. These are available in compliance packages of 21 tablets (DexPak ® 6 Day TaperPak® , NDC 0095-0089-21), 35 tablets (DexPak® 10 Day TaperPak® , NDC 0095-0087-35) and 51 tablets (DexPak ® 13 Day TaperPak® , NDC 0095-0088-51). Store at controlled room temperature 20º to 25ºC (68º to 77ºF), [see USP Controlled Room Temperature]. Dispense in tight, light resistant container as defined in the USP/NF. Rx Only Keep This and All Medications Out of the Reach of Children. Manufactured for: ECR Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured by: Mikart, Inc. Atlanta, GA 30318 ®/™ are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. © Valeant Pharmaceuticals North America LLC Rev. 11/2017 update p/n update p/n
Abbreviated New Drug Application
DEXAMETHASONE- DEXAMETHASONE TABLET ECR PHARMACEUTICALS ---------- DEXPAK 10 DAY TAPER PAK DEXAMETHASONE TABLETS, USP, 1.5 MG RX ONLY UPDATE P/N DESCRIPTION Dexamethasone tablets, USP, 1.5 mg, are for oral administration. Each tablet contains 1.5 mg of dexamethasone. Inactive ingredients are microcrystalline cellulose NF, anhydrous lactose NF, FD&C Red #40 aluminum lake, croscarmellose sodium NF, and magnesium stearate NF. The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α- methylpregna-1,4-diene-3,20-dione. The empirical formula is C H FO and the structural formula is: Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone. INDICATIONS AND USAGE _ALLERGIC STATES:_ Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. _DERMATOLOGIC DISEASES:_ Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe ® ® 22 29 5 erythema mult Lire le document complet