| Drug class |
Antifungal (azole) |
| Indication |
• Systemic mycoses (candidiasis, cryptococcal meningitis, invasive aspergillosis, histoplasmosis, etc.)
• Prophylaxis of invasive fungal infections in high‑risk patients (e.g., neutropenic, post‑transplant) |
| Typical dose |
• Adult: 400 mg IV once (loading), then 200 mg IV once daily (or 100 mg IV ½ day, depending on infection & renal function).
• Pediatric: weight‑based (often 12 mg/kg IV once, then 6 mg/kg IV once daily).
• Doses are adjusted for renal impairment (e.g., 200 mg q48 h in severe renal failure). |
| Concentrations shipped |
• 200 mg/10 mL (1 mg/mL) vials
• 400 mg/10 mL (4 mg/mL) vials (less common) |
| Vehicle |
0.9 % (isotonic) sodium chloride solution, sterile, preservative‑free. |
| Container |
Usually a polypropylene or PVC sterile vial or bag. |
| Label |
• Drug name & strength
• Date of manufacture & expiry date
• Storage conditions
• “Keep refrigerated, protected from light” (if advised) |
| Storage |
• 2–8 °C (refrigerated) until use.
• Once the vial/bag is opened, it should be used within 48 h at room temperature (≤25 °C) or within 24 h if stored in the fridge.
• Do not freeze. |
| Stability |
• USP < N > 2009 lists the solution stable for at least 30 days at 2–8 °C.
• After opening, the solution is stable for 4–6 h at room temperature if not already warmed. |
| Compatibility |
• Compatible with most IV fluids (NS, D5W, Lactated Ringer’s, etc.) when diluted to ≤200 mg/mL.
• Do not mix with 10 % or 20 % dextrose solutions (excessive sugar content).
• Compatible with most IV infusion pumps and sets; check manufacturer’s compatibility sheet if using high‑flow rates. |
| Preparation & Administration |
1. Inspect for color, clarity, and particulate matter.
2. Wash the vial/ bag with 70 % ethanol (if not pre‑sterile) and allow to dry.
3. Add the prescribed dose (e.g., 400 mg) directly to the vial or to a larger bag of NS if diluting for infusion.
4. Mix gently; avoid vigorous shaking.
5. Infuse over 60–90 min (or as per institutional protocol).
6. Do not use the solution beyond the stated time window. |
| Safety / Warnings |
• Allergy: Rarely, allergic reactions to the drug or excipients. If patient has known drug allergy, check cross‑reactivity with azoles.
• Renal function: Monitor creatinine & eGFR; dose adjustment necessary for impaired kidneys.
• Drug interactions: May potentiate nephrotoxicity of other nephrotoxic drugs (e.g., aminoglycosides, vancomycin).
• Contraindication: Hypersensitivity to fluconazole. |
| Plastic Container Concerns |
• Polypropylene (most common) is chemically inert and low‑leach.
• PVC containers may contain plasticizers (e.g., phthalates) that could leach; however, in pharmaceutical IV containers the amount is below regulatory limits.
• Avoid containers that have been previously used for other medications, especially those containing alcohol, as residual solvents could contaminate the solution.
• Light: The solution is light‑sensitive; store in a dark or amber container or wrap in foil. |
| Regulatory & QC |
• Must meet USP < N > 2009: “Fluconazole for IV infusion.”
• Check for sterility and pyrogenicity before use; do not use if the container is cracked, discolored, or shows cloudiness. |