DECADRON- dexamethasone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

dexamethasone (UNII: 7S5I7G3JQL) (dexamethasone - UNII:7S5I7G3JQL)

Available from:

Pragma Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial 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 first 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 adul

Product summary:

Decadron® tablets are available as: 0.5 mg tablets scored (yellow), debossed “Par-084” and supplied in bottles of 100, NDC 58463-014-01. 0.75 mg tablets scored (blue), debossed “Par-085” and supplied in bottles of 100, NDC 58463-015-01. 4 mg tablets scored (white), debossed “Par-087” and supplied in bottles of 100, NDC 58463-016-01. 6 mg tablets scored (white), debossed “Par-129” and supplied in bottles of 100, NDC 58463-017-01. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP/NF. Distributed by: Fera Pharmaceuticals, LLC for Pragma Pharmaceuticals, LLC Locust Valley, N.Y. 11560 Pragma ® PPI-014             Revised: 01/18 Decadron® is a registered trademark of Pragma Pharmaceuticals, LLC

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DECADRON- DEXAMETHASONE TABLET
PRAGMA PHARMACEUTICALS, LLC
----------
DECADRON TABLETS, USP
RX ONLY
DESCRIPTION
Decadron® Tablets 0.5 mg, 0.75 mg, 4 mg and 6 mg are for oral
administration. Each
tablet contains 0.5 mg, 0.75 mg, 4 mg or 6 mg of dexamethasone.
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. It is
designated chemically as 9-fluoro-11β, 17,
21-trihydroxy-16α-methylpregna-1,4-diene-
3,20-dione.
The structural formula is represented below:
Each tablet contains anhydrous lactose, croscarmellose sodium,
magnesium stearate,
microcrystalline cellulose and stearic acid. In addition, the 0.5 mg
tablet contains D&C
Yellow #10 and FD&C Yellow #5. The 0.75 mg tablet contains D&C Yellow
#10 and FD&C
Blue #1.
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, seasonal or perennial allergic rhinitis
and serum sickness.
DERMATOLOGIC DISEASES
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis
fungoides,
pemphigus, and severe er