DEXAMETHASONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

DEXAMETHASONE

Composition:

DEXAMETHASONE 4 mg

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, mycisis 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 (Diamon-Blackfan anemia), idiopathic thrombocytopenic purpura in adult

Product summary:

Dexamethasone tablets are available as:  4 mg tablets scored (white), debossed “Par-087” and supplied in bottles of 10, NDC 33261-0625-10. 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. Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, N.Y. 10977 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: 07/2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE- DEXAMETHASONE TABLET
AIDAREX PHARMACEUTICALS LLC
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DEXAMETHASONE 4MG TAB FOR PAR
DESCRIPTION
Dexamethasone Tablets 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg are for
oral administration. Each tablet
contains 0.5 mg, 0.75 mg, 1.5 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:
C
H FO
MW 392.47
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. The
1.5 mg tablet contains FD&C
Red #40. The 6 mg tablet contains D&C Yellow #10, FD&C Blue #1, and
FD&C Yellow #6.
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