Label: DEXAMETHASONE SODIUM PHOSPHATE injection

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 9, 2024

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  • 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 ...
  • ACTIONS
    Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are ...
  • 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 ...
  • CONTRAINDICATIONS
    Systemic fungal infections.
  • WARNINGS
    Serious Neurologic Adverse Reactions with Epidural Administration - Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific ...
  • PRECAUTIONS
    Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy ...
  • ADVERSE REACTIONS
    Fluid and electrolyte disturbances: Sodium retention - Fluid retention - Congestive heart failure in susceptible patients - Potassium loss - Hypokalemic alkalosis - Hypertension - Musculoskeletal: Muscle ...
  • DOSAGE AND ADMINISTRATION
    A. Intravenous or intramuscular administration. The initial dosage of Dexamethasone Sodium Phosphate Injection may vary from 0.50 mg/day to 9.0 mg/day depending on the specific disease entity ...
  • HOW SUPPLIED
    Dexamethasone Sodium Phosphate Injection, USP is available in the following package: 4 mg/mL - 1 mL vials packaged in 25s (NDC 0641-6145-25) 5 mL vials packaged in 10s (NDC 0641-6146-10) 10 ...
  • Sample Package Label 
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  • INGREDIENTS AND APPEARANCE
    Product Information