DEXAMETHASONE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Xspire Pharma, LLC

INN (Internationale Bezeichnung):

DEXAMETHASONE

Zusammensetzung:

DEXAMETHASONE 1.5 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DEXAMETHASONE- DEXAMETHASONE TABLET
XSPIRE PHARMA, LLC
----------
DEXAMETHASONE USP
DEXAMETHASONE TABLETS USP, 1.5 MG
RX ONLY
DESCRIPTION
Dexamethasone tablets USP, 1.5 mg for oral administration. Each tablet
contains anhydrous lactose,
croscarmellose sodium, magnesium stearate, microcrystalline cellulose
and stearic acid. In addition, the
1.5 mg tablet contains FD&C Red #40.
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 (hydrocortisone or cortisone is
the drug of choice; may be used in conjunction with synthetic
mineralocorticoid analogs where
applicable; in infancy mineralocorticoid sup