Nulecit
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Questions & Answers
Side Effects & Adverse Reactions
Hypersensitivity reactions have been reported with injectable iron products. See PRECAUTIONS.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
NulecitTM (sodium ferric gluconate complex in sucrose injection) is indicated for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.
History
There is currently no drug history available for this drug.
Other Information
NulecitTM (sodium ferric gluconate complex in sucrose injection) is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 to 440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages.
The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22O11)5]n≈200.
Each vial of 5 mL of NulecitTM for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 to 9.7.
Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.
Therapeutic Class: Hematinic
Sources
Nulecit Manufacturers
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Watson Pharma, Inc.
![Nulecit (Sodium Ferric Gluconate Complex) Injection [Watson Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nulecit | Watson Pharma, Inc.
The dosage of NulecitTM is expressed in terms of mg of elemental iron. Each 5 mL vial contains 62.5 mg of elemental iron (12.5 mg/mL).
The recommended dosage of NulecitTM for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of sodium ferric gluconate complex in sucrose injection (125 mg of elemental iron). NulecitTM may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour. NulecitTM may also be administered undiluted as a slow IV injection (at a rate of up to 12.5 mg/min). 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 intravenous iron at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits. Sodium ferric gluconate complex in sucrose injection has been administered at sequential dialysis sessions by infusion or by slow IV injection during the dialysis session itself.
Data from sodium ferric gluconate complex in sucrose injection postmarketing spontaneous reports indicate that individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events. See OVERDOSAGE.
Pediatric Dosage: The recommended pediatric dosage of NulecitTM for the repletion treatment of iron deficiency in hemodialysis patients is 0.12 mL/kg NulecitTM (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour at eight sequential dialysis sessions. The maximum dosage should not exceed 125 mg per dose.
Note: Do not mix NulecitTM with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility of NulecitTM with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit.
If diluted in saline, use immediately after dilution.
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