Product Specifications
| Specification | Details |
| Manufacturer / Brand | Hikma Pharmaceuticals USA Inc. |
| Manufacturer SKU / Item # | 00641036725 |
| NDC Number | 00641-0367-25 (Box) |
| Active Ingredient | Dexamethasone Sodium Phosphate (10 mg/mL equivalent) |
| Concentration / Strength | 10 mg/mL (High-Potency Concentration) |
| Total Content per Vial | 10 mg Dexamethasone Phosphate / 1 mL |
| Volume per Unit | 1 mL |
| Container Type | Glass Single-Dose Vial (SDV) |
| Administration Route | Intravenous (IV), Intramuscular (IM), Intra-Articular, Intralesional, Soft Tissue |
| Formulation | Preservative-Free / Sterile / Nonpyrogenic |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Protect from light and freezing) |
| Packaging Configuration | 25 Vials per Box / Pack |
| Regulatory Category | Prescription-Only (Rx) / ANDA Approved |
| HCPCS Code | J1100 |
Key Features & Clinical Applications
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High-Potency Anti-Inflammatory & Immunosuppressive Action: Delivers fast-acting corticosteroid therapy for acute allergic reactions, endocrine emergencies, cerebral edema, severe shock, and severe inflammatory conditions.
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Preservative-Free Formulation: Formulated without preservatives or benzyl alcohol, making it safe for neonatal, pediatric, and adult single-use applications where preservative sensitivity is a concern.
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Oncology & Acute Care Adjunct: High-potency single-dose configuration widely utilized in emergency departments, surgical centers, and oncology infusion settings for chemotherapy-induced nausea and vomiting (CNAV) and airway edema.
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Single-Dose Safety & Convenience: Individual 1 mL single-dose vials ensure strict single-patient sterile compliance and eliminate cross-contamination risk.
⚠️ Infection Masking & Immunosuppression: Glucocorticoids may mask signs of infection and decrease host resistance. Monitor patients closely for intercurrent bacterial, viral, or fungal infections during administration.
⚠️ Single-Use Protocol: Preservative-free single-dose vial. Discard any unused portion remaining in the vial immediately after initial administration.
⚠️ Route Precaution: Intra-articular injections must be performed under strict aseptic conditions to prevent septic arthritis. Avoid injecting into unstable or infected joints.
