Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)
REMEDYREPACK INC.
DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE PHOSPHATE 4 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION REMEDYREPACK INC. ---------- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP RX ONLY 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-16α-methyl-21- (phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical 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. Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains: 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. 22 28 2 8 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. Naturally occurring glucocorticoids (hydrocortisone and corti Lue koko asiakirja