DEXAMETHASONE elixir

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

STI Pharma LLC

INN (International Name):

Dexamethasone

Sammensetning:

Dexamethasone 0.5 mg in 5 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DEXAMETHASONE- DEXAMETHASONE ELIXIR
STI PHARMA LLC
----------
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 sickness.
COLLAGEN