DEXAMETHASONE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

A-S Medication Solutions

INN (International Name):

DEXAMETHASONE

구성:

DEXAMETHASONE 4 mg

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: 50090-0088 NDC: 50090-0088-4 6 TABLET in a BOTTLE, PLASTIC NDC: 50090-0088-0 30 TABLET in a BOTTLE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DEXAMETHASONE- DEXAMETHASONE TABLET
A-S MEDICATION SOLUTIONS
----------
DEXAMETHASONE TABLETS USP, DEXAMETHASONE ORAL SOLUTION USP AND
DEXAMETHASONE ORAL SOLUTION USP _INTENSOL_™ (CONCENTRATE)
DESCRIPTION
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
22
29
5
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 glucocortic