DEXAMETHASONE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

STAT Rx USA LLC

INN (International namn):

DEXAMETHASONE

Sammansättning:

DEXAMETHASONE 4 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

4 mg green, scored tablets (Identified 54 892). Available in Bottles of 10 tablets - NDC 16590-269-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a well-closed, light-resistant container as defined in the USP/NF.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

DEXAMETHASONE - DEXAMETHASONE TABLET
STAT RX USA LLC
----------
DEXAMETHASONE TABLETS USP,
RX ONLY
DESCRIPTION
Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP,
Dexamethasone Oral Solution, 0.5 mg per 5
mL and Dexamethasone _Intensol_™ Oral Solution (Concentrate), 1 mg
per mL are for oral administration.
Each tablet contains:
Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg
Each 5 mL of Oral Solution contains:
Dexamethasone.......................................................
0.5 mg
Each mL of _Intensol_ ™ Oral Solution (Concentrate) contains:
Dexamethasone....................................................... 1
mg
Alcohol 30%
INACTIVE INGREDIENTS
The tablets contain lactose monohydrate, magnesium stearate, starch,
sucrose, cosmetic ochre (1 mg),
D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C
Green No. 3 (4, 6 mg),
FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No.
6 (0.5, 4 mg).
The oral solution contains citric acid, disodium edetate, flavoring,
glycerin, methylparaben, propylene
glycol, propylparaben, sorbitol and water.
The _Intensol_™ oral solution contains alcohol, benzoic acid, citric
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
molecular 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 (hydrocortisone
and cortisone), which also have sodium-retaining properties, are used
as replacement therapy in
adrenocortical deficiency