Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
STI Pharma LLC
Dexamethasone
Dexamethasone 0.5 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Baca dokumen lengkapnya