Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
Dexamethasone (UNII: 7S5I7G3JQL) (Dexamethasone - UNII:7S5I7G3JQL)
Rising Pharma Holdings, Inc.
Dexamethasone
Dexamethasone 0.5 mg in 5 mL
ORAL
PRESCRIPTION DRUG
- 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 lup
Dexamethasone Elixir, USP 0.5 mg/5 mL is supplied as a clear, red, raspberry-flavored liquid in the following size: 8 fl oz (237 mL) bottle (NDC 64980-509-24) RECOMMENDED STORAGE Store at 20˚-25˚C (68˚-77˚F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight container as defined in the USP. Rx Only Manufactured for: Rising Pharmaceuticals, Inc. East Brunswick, NJ 08816 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R8-11/22
Abbreviated New Drug Application
DEXAMETHASONE- DEXAMETHASONE ELIXIR RISING PHARMA HOLDINGS, INC. ---------- DEXAMETHASONE ELIXIR, USP DESCRIPTION EACH 5 ML (TEASPOONFUL) CONTAINS: Dexamethasone, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg ALSO CONTAINS: Benzoic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.1% (as preservative) 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 mine Leggi il documento completo