| Reconstitution:
Aseptically reconstitute each 50 mg vial with 15 mL of
the companion diluent (20% (w/w) Dehydrated Alcohol in
Water for Injection) to provide a concentration of 3.33
mg/mL. The reconstituted solution should be stored at 25°C
(77°F); excursions permitted to 15–30°C (59–86°F).
Do not freeze. The reconstituted solution must be
further diluted and administered within 24 hours.
DOSAGE
AND ADMINISTRATION
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.
Esophageal candidiasis
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.
RENAL
DOSING:
Dosage adjustments are not required for patients with
any degree of renal insufficiency including those on
hemodialysis.
STORAGE
Unreconstituted vials: ERAXIS for Injection unreconstituted vials and companion
diluent vials should be stored at 25°C (77°F);
excursions permitted to 15–30°C (59–86°F). Do not
freeze.
Reconstituted vials:
Reconstituted ERAXIS for Injection should be stored at
25°C (77°F); excursions permitted to 15–30°C
(59–86°F). Do not freeze. The reconstituted vials
must be further diluted and administered within 24
hours.
Aseptically transfer the
contents of the reconstituted vial(s) into the
appropriately sized IV bag (or bottle) containing either
D5W or 0.9% NS.
| Dilution
requirements for ERAXIS
Administration |
| Dose |
Number
of
50 mg Vials |
Total
Reconstituted
Volume |
Infusion
Volume |
Total
Infusion
Volume |
Infusion
Solution
Concentration |
| 50 mg |
1 |
15
mL |
100
mL |
115
mL |
0.43 mg/mL |
| 100 mg |
2 |
30
mL |
250
mL |
280
mL |
0.36 mg/mL |
| 200 mg |
4 |
60
mL |
500
mL |
560
mL |
0.36 mg/mL |
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 are identified, discard the solution.
The
rate of infusion should not exceed 1.1 mg/minute.
Source:
Eraxis [package insert]. New York, NY: Pfizer inc, 2007
|
