Country: United States
Language: English
Source: NLM (National Library of Medicine)
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Mylan Institutional LLC
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). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode o
Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows: NDC Number Fill volume Pack size 67457-419-01 1 mL Single-Dose Vial 25’s 67457-418-05 5 mL Multi-Dose Vial 25’s 67457-484-30 30 mL Multi-Dose Vial 25’s Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows: NDC Number Fill volume Pack size 67457-483-10 10 mL Multi-Dose Vial 10’s 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. Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A. Manufacture by: Mylan Laboratories Limited Bangalore, India SEPTEMBER 2018 Novaplus is a registered trademark of Vizient, Inc.
Abbreviated New Drug Application
DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION MYLAN INSTITUTIONAL LLC ---------- 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 Read the complete document