A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ferrlecit Indications, Dosage, Storage, Stability - Sodium ferric gluconate
Ferrlecit Indications, Dosage, Storage, Stability - Sodium ferric gluconate
INDICATIONS
AND USAGE
Ferrlecit® is indicated for treatment of iron deficiency
in patients undergoing chronic hemodialysis who are receiving supplemental erythropoetin
therapy.
DOSAGE AND ADMINISTRATION
The dosage of Ferrlecit® is expressed in terms of mg of
elemental iron. Each 5ml ampule contains 62.5mg of elemental iron (12.5mg/ml).
Before initiating therapeutic doses of Ferrlecit®, administration
of an intravenous test dose of 2ml Ferrlecit® (25 mg of elemental iron)
is recommended. This test dose should be diluted in 50ml of 0.9% sodium chloride
for injection and administered over sixty minutes.
The recommended dosage of Ferrlecit® for the repletion
treatment of iron deficiency in hemodialysis patients is 10ml of Ferrlecit®
(125mg of elemental iron) diluted in 100 mL of 0.9% sodium chloride for injection,
administered by intravenous infusion over 1 hour. Most patients will require
a minimum cumulative dose of 1.0 gram of elemental iron, administered over eight
sessions at sequential dialysis treatments, to achieve a favorable hemoglobin
or hematocrit response. Patients may continue to require therapy with Ferrlecit®
or other intravenous iron preparations at the lowest dose necessary to maintain
the target levels of hemoglobin, hematocrit, and laboratory parameters of iron
storage within acceptable limits.
Ferrlecit® has been administered at sequential dialysis
sessions by infusion during the dialysis session itself.
Note: Do not mix Ferrlecit® with other medications,
or add to parenteral nutrition solutions for intravenous infusion. The compatibility
of Ferrlecit® with intravenous infusion vehicles other than 0.9% sodium
chloride for injection has not been evaluated. Parenteral drug products should
be inspected visually for particulate matter and discoloration before administration,
whenever the solution and container permit.
Use immediately after dilution in saline.
HOW SUPPLIED
Ferrlecit® is supplied in colorless glass ampules containing
a viscous dark red solution with no visible particulate matter. Each ampule
contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in
cartons of 10 ampules.
Store at 20oC-25oC (68oF-77oF); excursions permitted to 15-30oC
(59-86oF). See USP Controlled Room Temperature.
Caution: Rx Only
© Schein Pharmaceutical, Inc., and R&D
Laboratories, Inc. 1998. [Schein Pharmaceutical, Inc. Logo] [R&D Laboratories,
Inc. Logo]
February 18, 1999 NDA 20-955 Ferrlecit
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