Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)
General Injectables and Vaccines, Inc
DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE PHOSPHATE 4 mg in 1 mL
INTRA-ARTICULAR
PRESCRIPTION DRUG
A. By intravenous or intramuscular injection when oral therapy is not feasible: 1. Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). 2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of : Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases: Pemphigus. Se
Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows: Dexamethasone sodium phosphate injection, USP 10 is for intravenous and intramuscular injection only available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing.
Abbreviated New Drug Application
DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION GENERAL INJECTABLES AND VACCINES, INC ---------- DEXAMETHASONE SODIUM PHOSPHATE DESCRIPTION Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro- 11β,17-dihydroxy-16a-methyl-21(phosphonozxy) pregna-1, 4-dilene-3,20-dione disodium salt. The empiracal formula is C H FNa O P and the structural formula is: Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/mL and 10 mg/mL. Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration. Each mL contains: ACTIVE: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). PRESERVATIVES: Methylparaben 1.5 mg; Propylparaben 0.2 mg. INACTIVES: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. Dexamethason sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains: 22 28 2 8 ACTIVES: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). PRESERVATIVES: Methylparaben 1.5 mg; Propylparaben 0.2 mg. INACTIVES: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. CLINICAL PHARMACOLOGY Dexamethasone sodium phosphate injection has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy. Natural Διαβάστε το πλήρες έγγραφο