Dexamethasone sodium phosphate 10 mg/mL (expressed as the phosphate)

Basic Info

CAS Number	2392-39-4
Active Ingredient	Dexamethasone sodium phosphate (strength expressed as the phosphate)
Dosage Form	Solution
Specification & Packaging	Strength: 10 mg/mL (expressed as the phosphate) Pack: 1 vial Group: 02 Item No.: 36

Storage & Common Excipients

Storage Conditions	Tightly closed, protected from light, 15–25 °C (some labels specify ≤20 °C); do not freeze — follow the label
Common Excipients	Typical aqueous injectable: sodium chloride (tonicity), benzyl alcohol (preservative), polysorbate 80/poloxamer (solubilisation), edetate disodium, buffer (phosphate/citrate); supplied in ampoules. Confirm against COA

Product Introduction

The water-soluble phosphate salt of a glucocorticoid, formulated as an injectable solution for intravenous or intramuscular administration. A prescription medicine, dispensed against prescription only

Therapeutic Use

Conditions requiring prolonged systemic glucocorticoid therapy (rheumatic disease, asthma, severe allergy, certain haematological malignancies), acute allergic reactions, cerebral oedema related to brain tumour or stroke, adjunctive use in bacterial infection (must be combined with antibiotics), and prevention of neonatal respiratory distress syndrome; indications follow the locally approved label

Mode of Action

A glucocorticoid-receptor agonist acting through gene transcription to produce anti-inflammatory and immunosuppressive effects; the phosphate is a prodrug requiring hydrolysis to release dexamethasone; dexamethasone is a long-acting (intermediate-potent) glucocorticoid, longer acting than prednisone

Administration & Monitoring

Taper stepwise as prescribed — never stop abruptly (risk of HPA-axis suppression); monitor blood glucose, blood pressure, electrolytes, full blood count, infection signs, eyes (cataract/glaucoma) and bone density; vaccinate and screen for tuberculosis during long-term therapy

Important Safety Information

Prescription medicine; contraindicated in uncontrolled infection. Long-term use can cause serious adverse effects (Cushing syndrome, osteoporosis, worsening infection). Increased GI bleeding risk with NSAIDs; co-administration with live vaccines can cause fatal infection

Adverse Reactions

Sodium and water retention, hypertension, hypokalaemia, oedema; raised blood glucose and worsening diabetes; increased infection risk (opportunistic infections, reactivation of TB/fungal disease); osteoporosis, avascular necrosis of the femoral head; cataract and glaucoma; skin thinning and delayed wound healing; psychiatric symptoms (insomnia, emotional instability, depression, occasional psychosis); myopathy; growth suppression in children

Important Risks

HPA-axis suppression with adrenal crisis on sudden withdrawal; serious and opportunistic infection; GI bleeding and perforation; severe hyperglycaemia; psychiatric and mood-related risk (sometimes misattributed to stimulant-like effects)

Contraindications

Hypersensitivity; uncontrolled bacterial, viral or fungal infection (unless appropriate antimicrobial therapy is given concurrently); active tuberculosis; active peptic ulcer or severe GI disease (relative); severe hepatic or renal impairment (relative); paediatric use requires careful risk-benefit assessment; proliferative psychosis (relative)

Special Populations

Use with great caution in children and at the lowest effective dose, as prolonged therapy suppresses growth; prolonged use in pregnancy carries teratogenic and cleft-palate risk; older patients have higher osteoporosis and infection risk; monitor closely in diabetes

Usage Limitations

Prescription-only; use only with a clear indication and the ability to monitor; must be tapered; for athletes, glucocorticoids are on the WADA Prohibited List S9 (non-therapeutic use prohibited, therapeutic use requires a TUE and is reported through urinary testing); procurement and storage as a prescription medicine

Anti-Doping Testing

Glucosanabolic agents are on the WADA Prohibited List S9 (prohibited for performance enhancement); laboratories report urinary glucocorticoids at non-therapeutic levels; athletes must obtain a TUE for legitimate therapeutic use

Product Quality Testing

Identification (HPLC/MS/FTIR), assay and content uniformity, related substances (phosphate/free dexamethasone ratio), pH, osmolality, clarity and particulate matter, fill volume, sterility and bacterial endotoxin, residual solvents, stability; COA