Label: DEXAMETHASONE SODIUM PHOSPHATE injection
- NDC Code(s): 0404-9805-05
- Packager: Henry Schein, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0641-6146
- 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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- Official Label (Printer Friendly)
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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 ...
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ACTIONS
Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are ...
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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 ...
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CONTRAINDICATIONS
Systemic fungal infections.
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WARNINGS
Serious Neurologic Adverse Reactions with Epidural Administration - Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific ...
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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 ...
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ADVERSE REACTIONS
Fluid and electrolyte disturbances: Sodium retention - Fluid retention - Congestive heart failure in susceptible patients - Potassium loss - Hypokalemic alkalosis - Hypertension - Musculoskeletal: Muscle ...
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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 ...
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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 ...
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Sample Package Label
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INGREDIENTS AND APPEARANCEProduct Information