Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Physicians Total Care, Inc.
DEXAMETHASONE
DEXAMETHASONE 1.5 mg
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 ad
Dexamethasone tablets USP 1.5mg are scored, pink, pentagonal-shaped tablets debossed “ECR 86”. These are available in compliance packages of Store at controlled room temperature 20º to 25ºC (68º to 77ºF), see USP. 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 Richmond, Virginia 23255 Manufactured by: Mikart, Inc. Atlanta, GA 30318 MI 0087/88/89 Rev. 11/08 Code 970A00 Rev. 06/08 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
DEXAMETHASONE - DEXAMETHASONE TABLET PHYSICIANS TOTAL CARE, INC. ---------- DEXAMETHASONE 13 DAY PACK DESCRIPTION Dexamethasone tablets USP, 1.5mg for oral administration. 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 C22H29F05 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 erythema multiforme (Stevens-Johnson syndrome) _ENDOCRINE DISORDERS_ Primary or secondary adrenocortical insufficiency (hyd Lue koko asiakirja