Dosing and uses of Ferrlecit, Nulecit (ferric gluconate)
Adult dosage forms and strengths
injectable solution
- 12.5mg elemental Fe/mL; 10 mL ampules
Chronic Hemodialysis with Erythropoietin Treatment
125 mg IV infusion over 1 hr; not to exceed 250 mg/infusion for 8 dialysis sessions
May dilute in 100 mL 0.9% NaCl and administer over 1 hr
May administer undiluted; not to exceed administration rate of 12.5 mg/min
Pediatric dosage forms and strengths
injectable solution
- 12.5mg elemental Fe/mL
Chronic Hemodialysis with Erythropoietin Treatment
<6 years: Safety and efficacy not established
>6 years: 1.5 mg/kg elemental Fe IV infusion over 1 hr for 8 sessions
Not to exceed 125 mg/dose
Ferrlecit, Nulecit (ferric gluconate) adverse (side) effects
>10%
Diarrhea (35%)
Nausea (35%)
Vomiting (35%)
Injection site reaction (33%)
Hypotension (29%)
Cramps (25%)
Dizziness (13%)
Hypertension (13%)
Dyspnea (11%)
Chest pain (10%)
1-10%
Asthenia
Headache
Syncope
Fatigue
Fever
Edema
Cough
Upper respiratory tract infection
Abdominal pain
Hyperkalemia
Electrolyte abnormalities
Pruritus
Leg cramps
Warnings
Contraindications
Hemochromatosis, hemosiderosis, hemolytic anemia, PUD, ulcerative colitis
Cautions
DO NOT mix Ferrlecit with other meds or add to TPN; compatibility has not been established
Significant hypotension may occur following administration; may resolve within 1-2hr
Contains benzyl alcohol, which is associated with gasping syndrome in neonates (not for use in neonates)
Iron overload may occur in patients with hemoglobinopathies or other refractory anemias
Pregnancy and lactation
Pregnancy category: B
Lactation: Excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ferrlecit, Nulecit (ferric gluconate)
Mechanism of action
Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin
Pharmacokinetics
Half-Life: 1 hr
Vd: 6 L
Clearance: 3.02-5.35 L/hr
Excretion: urine, 0.5-1 mg/day
Administration
IV Compatibilities
Solution: Ns
IV Incompatibilities
All other medications, parenteral nutrition solutions
IV Preparation
Dilute 10 mL Ferrlecit (125 mg Fe) in 100 mL Ns
IV Administration
IV infusion over 1 hr
