DEXAMETHASONE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

제공처:

Bryant Ranch Prepack

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Product: 63629-4127 NDC: 63629-4127-1 35 TABLET in a BOTTLE NDC: 63629-4127-2 21 TABLET in a BOTTLE NDC: 63629-4127-3 51 TABLET in a BOTTLE NDC: 63629-4127-4 90 TABLET in a BOTTLE NDC: 63629-4127-5 120 TABLET in a BOTTLE NDC: 63629-4127-6 100 TABLET in a BOTTLE NDC: 63629-4127-7 55 TABLET in a BOTTLE NDC: 63629-4127-8 10 TABLET in a BOTTLE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DEXAMETHASONE- DEXAMETHASONE TABLET
BRYANT RANCH PREPACK
----------
DEXAMETHASONE TABLETS USP, DEXAMETHASONE ORAL SOLUTION USP AND
DEXAMETHASONE ORAL
SOLUTION USP _INTENSOL_™ (CONCENTRATE)
DES CRIPTION
Dexamethasone Tablets USP are available for oral administration
containing either 0.5 mg, 0.75 mg, 1
mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet
contains the following inactive
ingredients: lactose monohydrate, magnesium stearate, starch, sugar,
D&C Yellow #10 (0.5 mg and 4
mg), FD&C Blue #1 (0.75 mg and 1.5 mg), FD&C Green #3 (4 mg and 6 mg),
FD&C Red #3 (1.5 mg),
FD&C Red #40 (1.5 mg), FD&C Yellow #6 (0.5 mg and 4 mg) and Yellow
Iron Oxide (1 mg).
Dexamethasone Oral Solution USP is formulated for oral administration
containing 0.5 mg per 5 mL of
dexamethasone USP. The cherry brandy flavored oral solution contains
the following inactive
ingredients: anhydrous citric acid, cherry brandy flavor, disodium
edetate, glycerin, methylparaben,
propylene glycol, propylparaben, sorbitol solution and water.
Dexamethasone Oral Solution USP Intensol™ (Concentrate) is
formulated for oral administration
containing 1 mg per mL of dexamethasone USP. In addition, the oral
solution contains the following
inactive ingredients: alcohol 30% v/v, anhydrous citric acid, benzoic
acid, disodium edetate, propylene
glycol and water.
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
empirical formula is C
H FO . The
molecular weight is 392.47. It is designated chemically as
9-fluoro-11β,17,21-trihydroxy-16α-
methylpregna-1,4-diene,3,20-dione and the structural formula is:
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 (hydroc