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Ferric Citrate Tablets
  • Professionals
  • FDA PI

Ferric Citrate Tablets

Generic name: tetraferric tricitrate decahydrate
Dosage form: tablet, coated
Drug class:Phosphate binders

Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.

Indications and Usage for Ferric Citrate Tablets

Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

Ferric Citrate Tablets Dosage and Administration

Dosing and Dose Adjustment

The recommended starting dose is 2 tablets orally 3 times per day with meals. Serum phosphorus levels should be monitored and the dose of Ferric Citrate titrated in decrements or increments of 1 to 2 tablets per day as needed to maintain serum phosphorus at target levels, up to a maximum dose of 12 tablets daily. Dose can be titrated at 1-week or longer intervals.

In a clinical trial conducted in the United States, patients required an average of 8 to 9 tablets a day to control serum phosphorus levels.

Dosage Forms and Strengths

Tablet: Ferric Citrate 210 mg ferric iron, equivalent to 1 g ferric citrate, film-coated, peach-colored, and oval-shaped tablet embossed with “KX52”.

Contraindications

Ferric Citrate is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see Warnings and Precautions (5.1)].

Warnings and Precautions

Iron Overload

Iron absorption from Ferric Citrate may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial in which concomitant use of Ferric Citrate and IV iron was permitted, 55 (19%) of patients treated with Ferric Citrate had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control.