DEXAMETHASONE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Xspire Pharma, LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic a

Descriptif du produit:

Dexamethasone tablets USP 1.5 mg are scored, pink, pentagonal-shaped tablets debossed "DEX" over the score and "1.5" below the score. The opposite side is plain. Available in bottles of 100 tablets, NDC 42195-151-10. Storage: Store at controlled room temperature 20º to 25ºC (68º to 77ºF), see USP. Dispense in tight, light resistant container as defined in the USP/NF. Rx Only Keep This and All Medications Out of the Reach of Children Manufactured for: Xspire Pharma Ridgeland, MS 39157 Rev. 04/2018 500477-03

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

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