DEXAMETHASONE elixir

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Atopic dermatitis, Bronchial asthma, Contact dermatitis, Drug hypersensitivity reactions, Seasonal or perennial allergic rhinitis, and Serum sickness. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus, and Acute rheumatic carditis. Dermatologic Diseases Bullous dermatitis herpetiformis, Exfoliative dermatitis, Mycosis fungoides, Pemphigus, Severe erythema multiforme (Stevens-Johnson syndrome), Severe psoriasis, and Severe seborrheic dermatitis. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 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; i

Product summary:

Dexamethasone Elixir, 0.5 mg dexamethasone per 5 mL, is a clear pinkred liquid supplied in the following size: 8 fl oz (No Dropper) (237 mL) Store at 25ºC (77ºF); excursions permitted from 15º to 30º C (59º to 86ºF). [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight, light-resistant container as defined in the USP. To report SUSPECTED ADVERSE REACTIONS, contact STI Pharma. LLC at 1-888-301-9680 or FDA at 1·800-FDA·1088 or www.fda.gov/medwatch Rx Only Manufactured for STI Pharma LLC Newtown, PA 18940 Rev.0911

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE- DEXAMETHASONE ELIXIR
AIDAREX PHARMACEUTICALS LLC
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DEXAMETHASONE ELIXIR, USP
0.5 MG / 5 ML
DESCRIPTION
EACH 5 ML (TEASPOONFUL) CONTAINS:
Dexamethasone, USP……………………………………0.5 mg
ALSO CONTAINS:
Benzoic Acid, USP………………………………………. .0.1%
(as a preservative)
Alcohol………………………………………………………5%
INACTIVE INGREDIENTS: Artificial raspberry flavor, citric acid,
edetate disodium, FD&C Red #40,
propylene glycol, purified water, saccharin sodium, sorbitol solution.
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
ALLERGIC STATES
Control of severe or incapacitating allergic conditions intractable to
adequate trials of conventional
treatment: Atopic dermatitis, Bronchial asthma, Contact dermatitis,
Drug hypersensitivity reactions,
Seasonal or perennial allergic rhinitis, and Serum sickne