DEXAMETHASONE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

PD-Rx Pharmaceuticals, Inc.

INN（国际名称）:

DEXAMETHASONE

组成:

DEXAMETHASONE 0.75 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Systemic fungal infections (see WARNINGS: Fungal Infections) and in patients who are hypersensitive to any components of these products.

產品總結:

Dexamethasone Tablets USP 0.75 mg tablets are supplied as a pale blue, flat tablet with beveled edges, scored on one side and product identification “54 960” debossed on the other side. NDC 55289-903-10: Bottle of 10 Tablets NDC 55289-903-12: Bottle of 12 Tablets NDC 55289-903-20: Bottle of 20 Tablets Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight light-resistant, child-resistant container as defined in the USP/NF.

授权状态:

Abbreviated New Drug Application

产品特点

DEXAMETHASONE- DEXAMETHASONE TABLET
PD-RX PHARMACEUTICALS, INC.
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DEXAMETHASONE TABLETS USP
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
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are
22
29
5
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