DECADRON- dexamethasone elixir

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:

- Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer - Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis - Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Acute rheumatic carditis - Dermatologic Dise

Product summary:

DECADRON® Dexamethasone Elixir, USP 0.5 mg/5 mL is supplied as a clear, red, raspberry-flavored liquid in the following size:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DECADRON- DEXAMETHASONE ELIXIR
PRAGMA PHARMACEUTICALS, LLC
----------
DECADRON
DEXAMETHASONE ELIXIR, USP
(0.5 MG/5 ML)
DESCRIPTION
EACH 5 ML (TEASPOONFUL) CONTAINS:
Dexamethasone, USP ............................ 0.5 mg
ALSO CONTAINS:
Benzoic Acid, USP (as preservative) .................................
0.1%
Alcohol (% v/v) ................................... 5.1%
INACTIVE INGREDIENTS: artificial raspberry flavor; citric acid; FD&C
red no. 40; sucrose; propylene
glycol and purified water. IT MAY ALSO CONTAIN sodium citrate
dihydrate.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic, which are readily
absorbed from the gastrointestinal tract.
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 weight is 392.47. It is
designated chemically as
9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione.
The
molecular formula is C
H FO and the structural formula is:
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids, (hydrocortisone and cortisone),
which also have salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. Their synthetic analogs,
including dexamethasone, are primarily used for their potent
anti-inflammatory effects in disorders of
many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify the body's
immune responses to diverse stimuli.
At equipotent anti-inflammatory doses, dexamethasone almost completely
lacks the sodium-retaining
property of hydrocortisone and closely related derivatives of
hydrocortisone.
INDICATIONS AND USAGE
1. _ Endocrine Disorders:_ Primary or secondary adrenocortical
insufficiency (hydrocortisone or
cortisone is the first choice; synthetic analogs may be used in
conjunction with mineralocorticoids
where applicable; in infancy mineralocorticoid supplementation is of
particular importance).
Congenital adrenal hy