DEXAMETHASONE 6-DAY- dexamethasone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Xspire Pharma, Llc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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. These are available in tapered therapy packages of 21 tablets (Dexamethasone 6-Day Therapy Pack, NDC 42195-721-21) 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. 04/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE 6-DAY- DEXAMETHASONE TABLET
XSPIRE PHARMA, LLC
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DEXAMETHASONE TABLETS USP, 1.5 MG
THERAPY PACK 6-DAY
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
mineralocortic