DEXAMETHASONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

DEXAMETHASONE

Composition:

DEXAMETHASONE 4 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE- DEXAMETHASONE TABLET
AMERICAN HEALTH PACKAGING
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DEXAMETHASONE TABLETS, USP
8428901/0117
RX ONLY
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.
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
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5
perennial allergic rhinitis and serum sickness.
_DERMATOLOGIC DISEA