Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Levins Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
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 erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: 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. Gastrointestinal Disease: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia,
Dexabliss Tablets USP, 1.5 mg are supplied as white, round shaped tablets debossed “702” on one side and bisected on the opposite side the bisect on the tablet provides for a functional scoring of the tablets to ensure accurate breaking. They are supplied in packages of 39 tablets, with child-resistant closure, 11-day Dose Pack, (NDC# 71905-400-11).
Abbreviated New Drug Application
DEXABLISS- DEXAMETHASONE TABLET LEVINS PHARMACEUTICALS, LLC ---------- DEXABLISS (DEXAMETHASONE TABLETS USP), 1.5 MG RX ONLY DES CRIPTION Dexamethasone Tablets USP, 1.5 mg Each Tablet contains: Dexamethasone USP, 1.5 mg For oral administration INACTIVE INGREDIENTS Dexamethasone Tablets USP, 1.5 mg contain lactose monohydrate, magnesium stearate, starch and compressible sugar. 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. The molecular formula is C22N29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11B,17,21 -trihydroxy-16 a – methylpregna-1,4-diene-3,20-dione and the structural formula 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 erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adr Läs hela dokumentet