DEXAMETHASONE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Key Therapeutics

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

A l l ergic   States:   Control of severe or incapacitating a llergic 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:   Bull ous 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 (aut

Resumen del producto:

Dexamethasone Tablets USP, 1.5 mg are supplied as white, round shaped tablets debossed “702” on one side and bisected on the opposite side. The bisect on the tablet provides for a functional   scoring   of the tablet to ensure accurate breaking. They are available in bottles of 100 tablets, NDC 70868-920-21. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a we l -closed, light-resistant container as defined in the USP/NF. Call   your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Distributed by: Key Therapeutics Flowood, MS 39232 Questions: [phone] Rev. 07/2023

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DEXAMETHASONE- DEXAMETHASONE TABLET
KEY THERAPEUTICS
----------
DEXAMETHASONE TABLETS USP
DEXAMETHASONE TABLETS USP, 1.5 MG
RX ONLY
DESCRIPTION
Dexamethasone Tablets USP, 1.5 mg
Each tablet contains: Dexamethasone USP … 1.5 mg.
For oral administration.
INACTIVE INGREDIENT
Dexamethasone Tablets USP, 1.5 mg contain lactose monohydrate,
magnesium
stearate, starch and compressible sugar.
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 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