מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)
HF Acquisition Co LLC, DBA HealthFirst
INTRAMUSCULAR
PRESCRIPTION DRUG
A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 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 sus
DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP is supplied in the following dosage forms. NDC 51662-1432-1 DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP 120mg PER 30mL (4mg/mL) 30mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible particles and is supplied as follows: 4 mg per mL 1 mL Single-Dose Vials in a carton of 25 NDC 55150-237-01 20 mg per 5 mL (4 mg / mL) 5 mL Multiple-Dose Vials in a carton of 25 NDC 55150-238-05 120 mg per 30 mL (4 mg / mL) 30 mL Multiple-Dose Vials in a carton of 25 NDC 55150-239-30 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sensitive to heat - Do not autoclave. Protect from light. The vial stoppers are not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: July 2017
Abbreviated New Drug Application
DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION HF ACQUISITION CO LLC, DBA HEALTHFIRST ---------- DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP 120MG PER 30ML (4MG/ML)* 30ML VIAL DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP Rx only DESCRIPTION Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible particles and a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate USP, C22H28FNa2O8P, has a molecular weight of 516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-, disodium salt, (11β, 16α). It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula: Dexamethasone sodium phosphate injection USP is available in 4 mg/mL concentration. Each mL of dexamethasone sodium phosphate injection USP, 4 mg/mL, contains 4.37 mg of dexamethasone sodium phosphate, USP equivalent to 4 mg dexamethasone phosphate; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative). Made isotonic with sodium citrate. pH adjusted with citric acid or sodium hydroxide. ACTIONS — Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs 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. INDICATIONS & USAGE A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are in קרא את המסמך השלם