国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Dexamethasone Sodium Phosphate (UNII: AI9376Y64P) (Dexamethasone - UNII:7S5I7G3JQL)
Fresenius Kabi USA, LLC
Dexamethasone Sodium Phosphate
Dexamethasone 4 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
- 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: 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
Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL is available as: 4 mg/mL in a 1 mL pre-filled disposable single-use syringe (NDC 76045-210-00). Available in a carton of twenty-four (24) syringes. NDC 76045-210-10. This product contains an RFID. 4 mg/mL in a 1 mL pre-filled disposable single-use syringe, NDC 76045-106-10 Available in a carton of twenty-four (24) syringes. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat – Do not autoclave. Do not place syringe on a sterile field.
Abbreviated New Drug Application
DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION Fresenius Kabi USA, LLC ---------- INSTRUCTIONS FOR USE Figure 1: Outer Packaging and Prefilled Syringe NOTES: - Do not introduce any other fluid into the syringe at any time. - Do not dilute for IV push. - Do not re-sterilize the syringe. - Do not use this product on a sterile field. - This product is for single dose only. 1. Inspect the outer packaging (blister pack) to confirm the integrity of the packaging. Do not use if the blister pack or the prefilled syringe has been damaged. 2. Remove the syringe from the outer packaging. (See Figure 2) Figure 2 3. Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 4. Twist off the syringe tip cap. Do not remove the label around the luer lock collar. (See Figure 3) Figure 3 5. Expel air bubble(s). Adjust the dose (if applicable). 6. Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration. 7. Discard the used syringe into an appropriate receptacle. For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The brand names mentioned in this document are the trademarks of their respective owners. U.S. Patent 9,731,082 www.fresenius-kabi.com/us 451612 Revised: 10/2020 Revised: 1/2021 Document Id: 916ef348-1e5b-40b4-9d12-508fc2ce567c 34391-3 Set id: 88d25d19-acff-477b-86c8-9797782045b8 Version: 13 Effective Time: 20210120 Fresenius Kabi USA, LLC 阅读完整的文件
DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP RX ONLY DESCRIPTION Dexamethasone Sodium Phosphate Injection, USP is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, C H FNa O P, 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 creamy 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. Each mL of Dexamethasone Sodium Phosphate injection contains Dexamethasone Sodium Phosphate, USP equivalent to 4 mg of Dexamethasone Phosphate. 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 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 22 28 2 8 mineralocorticoids where applicable; in infancy, mineralocorticoid suppl 阅读完整的文件