2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
Candidemia and other Candida infections (intra-abdominal abscess, and peritonitis)
The recommended dose is a single 200 mg loading dose of ERAXIS on Day 1, followed by 100 mg daily dose thereafter. Duration of treatment should be based on the patient's clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.
The recommended dose is a single 100 mg loading dose of ERAXIS on Day 1, followed by 50 mg daily dose thereafter. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms. Duration of treatment should be based on the patient's clinical response. Because of the risk of relapse of esophageal candidiasis in patients with HIV infections, suppressive antifungal therapy may be considered after a course of treatment.
2.2 Preparation for Administration
Reconstitution 50 mg/vial
Aseptically reconstitute each 50 mg vial with 15 mL of sterile Water for Injection to provide a concentration of 3.33 mg/mL. The reconstituted solution can be stored for up to 24 hours at temperatures up to 25°C (77°F) prior to dilution into the infusion solution.
2.3 Dilution and Infusion
Aseptically transfer the contents of the reconstituted vial(s) into the appropriately sized IV bag (or bottle) containing either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline). See Table 1 for the dilution and infusion instructions for each dose.
|Dose||Number of Vials Required||Total Reconstituted Volume Required||Infusion Volume*||Total Infusion Volume†||Rate of Infusion||Minimum Duration of Infusion|
|50 mg||1–50 mg||15 mL||50 mL||65 mL||1.4 mL/min or 84 mL/ hour)||45 min|
|100 mg||2–50 mg or 1–100 mg||30 mL||100 mL||130 mL||1.4 mL/min or 84 mL/ hour)||90 min|
|200 mg||4–50 mg or 2–100 mg||60 mL||200 mL||260 mL||1.4 mL/min or 84 mL/ hour)||180 min|
Caution: The rate of infusion should not exceed 1.1 mg/minute (equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions) [see Warnings and Precautions (5.2)].
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or discoloration is identified, discard the solution.