DEXAMETHASONE elixir

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

Dexamethasone

Composition:

Dexamethasone 0.5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hyperplasia     Nonsuppurative thyroiditis     Hypercalcemia associated with cancer 2.  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 3.  Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of:     Systemic lupus erythematosus     Ac

Product summary:

DEXAMETHASONE ELIXIR 0.5 mg/5 mL is supplied as a clear, red, raspberry-flavored liquid in the following sizes: 100 mL fill in a 4 fl oz bottle with separately packaged dropper assembly. Dropper graduated for 0.125 mg and 0.25 mg. 8 fl oz (No Dropper) (237 mL) (NDC 60432-466-08) Store at controlled room temperature, 15 ° to 30°C (59° to 86°F). KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight container as defined in the USP. Rx Only Product No.: 8466 Manufactured By:  Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053 A50-8466-08 REV. 07-18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE- DEXAMETHASONE ELIXIR
MORTON GROVE PHARMACEUTICALS, INC.
----------
DEXAMETHASONE ELIXIR, USP
RX ONLY
DESCRIPTION
EACH 5 ML (TEASPOONFUL) CONTAINS:
Dexamethasone, USP 0.5 mg
ALSO CONTAINS:
Benzoic Acid, USP 0.1%
(as preservative)
Alcohol 5.1%
INACTIVE INGREDIENTS: Artificial Raspberry Flavor; Citric Acid, USP;
FD&C Red No. 40; Liquid Sugar;
Propylene Glycol, USP and Purified Water, USP. IT MAY ALSO CONTAIN
Sodium Citrate, USP.
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
antiinflammatory 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
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29
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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 hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. _Rheumatic D