País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Advanced Rx Pharmacy of Tennessee, LLC
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 (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied in a single dose vial as follows: 80425-0261-01 The vial stopper closure is not made with natural rubber latex. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sensitive to heat. Do not autoclave. Protect from freezing. Protect from light. Single dose vials –Store in container until time of use. Discard unused portion. Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 PSSO0376 ST-DEX21/P/04 Revised: 05/2021 Made in India Neutral Code No: TN/DRUGS/616/1996 PSMV0003 ST-DEX-MPPL/P/00 Distributed by: Advanced Rx Pharmacy of Tennessee, LLC Revised: 05/2021
Abbreviated New Drug Application
DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE INJECTION ADVANCED RX PHARMACY OF TENNESSEE, LLC ---------- DEXAMETHASONE SODIUM PHOSPHATE 10MG/ML INJECTION 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, USP chemically is Pregna-1,4-diene-3,20-dione, 9- fluoro- 11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to practically white powder, is hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula: Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg, sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid monohydrate or sodium hydroxide, if necessary. pH: 7.0 to 8.5. 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. 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 adrenocortic Leia o documento completo