Label: DEXAMETHASONE SODIUM PHOSPHATE injection

  • NDC Code(s): 0641-0367-21, 0641-0367-25, 0641-6145-01, 0641-6145-25, view more
  • Packager: Hikma Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 5, 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 ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0641-0367-21      Rx only - Dexamethasone - Sodium Phosphate - Injection, USP - 10 mg/mL - (dexamethasone phosphate equivalent) For IV or IM use ONLY - Protect from light - 1 mL Vial - NDC ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0641-6145-01   Rx only - Dexamethasone - Sodium Phosphate - Injection, USP - 4 mg/mL        (dexamethasone phosphate equivalent) For IV, IM, Intralesional, Intra-articular or - Soft Tissue ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0641-6146-01    Rx only - Dexamethasone - Sodium Phosphate Injection, USP - 20 mg per 5 mL (4 mg/mL)       (dexamethasone phosphate equivalent) For IV, IM, Intralesional, Intra-articular or ...
  • INGREDIENTS AND APPEARANCE
    Product Information