DOSAGE AND ADMINISTRATION
Use only the components [SPORANOX® (itraconazole) Injection ampule, 0.9% Sodium Chloride Injection, USP (Normal Saline) bag and filtered infusion set] provided in the kit: DO NOT SUBSTITUTE.
SPORANOX® Injection should not be diluted with 5% Dextrose Injection, USP, or with Lactated Ringer's Injection, USP, alone or in combination with any other diluent. The compatibility of SPORANOX® Injection with diluents other than 0.9% Sodium Chloride Injection, USP (Normal Saline) is not known. NOT FOR IV BOLUS INJECTION.
NOTE: After reconstitution, the diluted SPORANOX® Injection may be stored refrigerated (2-8°C) or at room temperature (15-25°C) for up to 48 hours, when protected from direct light. During administration, exposure to normal room light is acceptable.
NOTE: Use only a dedicated infusion line for administration of SPORANOX® Injection. Do not introduce concomitant medication in the same bag nor through the same line as SPORANOX® Injection. Other medications may be administered after flushing the line/catheter with 0.9% Sodium Chloride Injection, USP, as described below, and removing and replacing the entire infusion line. Alternatively, utilize another lumen, in the case of a multi-lumen catheter.
Correct preparation and administration of SPORANOX® Injection are necessary to ensure maximal efficacy and safety. A precise mixing ratio is required in order to obtain a stable admixture. It is critical to maintain a 3.33 mg/mL itraconazole:diluent ratio. Failure to maintain this concentration will lead to the formation of a precipitate.
Add the full contents (25 mL) of the SPORANOX® Injection ampule into the infusion bag provided, which contains 50 mL of 0.9% Sodium Chloride Injection, USP (Normal Saline). Mix gently after the solution is completely transferred. Withdraw and discard 15 mL of the solution before administering to the patient. Using a flow control device, infuse 60 mL of the dilute solution (3.33 mg/mL = 200 mg itraconazole, pH apx. 4.8) intravenously over 60 minutes, using an extension line and the infusion set provided. After administration, flush the infusion set with 15-20 mL of 0.9% Sodium Chloride Injection, USP, over 30 seconds-15 minutes, via the two-way stopcock. Do not use Bacteriostatic Sodium Chloride Injection, USP. The compatibility of SPORANOX® Injection with flush solutions other than 0.9% Sodium Chloride Injection, USP (Normal Saline) is not known. Discard the entire infusion line.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Empiric Therapy in Febrile, Neutropenic Patients with Suspected Fungal Infections (ETFN): The recommended dose of SPORANOX® Injection is 200 mg b.i.d. for four doses, followed by 200 mg once daily for up to 14 days. Each intravenous dose should be infused over 1 hour. Treatment should be continued with SPORANOX® Oral Solution 200 mg (20 mL) b.i.d. until resolution of clinically significant neutropenia. The safety and efficacy of SPORANOX® use exceeding 28 days in ETFN is not known.
Treatment of Blastomycosis, Histoplasmosis and Aspergillosis: The recommended intravenous dose is 200 mg b.i.d. for four doses, followed by 200 mg q.d. Each intravenous dose should be infused over 1 hour.
For the treatment of blastomycosis, histoplasmosis and aspergillosis, SPORANOX® can be given as oral capsules or intravenously. The safety and efficacy of SPORANOX® Injection administered for greater than 14 days is not known.
Total itraconazole therapy (SPORANOX® Injection followed by SPORANOX® Capsules) should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.
SPORANOX® Injection should not be used in patients with creatinine clearance <30 mL/min.