Citofer(Ferric Iron)
Therapeutic Group: Phosphate Binder/Iron replacement
Presentation
Citofer 210 mg tablet: Each tablet contains Ferric Citrate INN equivalent to Ferric Iron 210 mg.
Description
Ferric Citrate is a phosphate binder and Iron replacement product, is known chemically as Iron (+3) compound. Citofer 210 mg Ferric Iron tablets for oral administration, equivalent to 1 gm Ferric Citrate is a film-coated and oval-shaped tablets.
Indications
1. Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis.
2. Besides it is used as an Iron replacement product indicated for the treatment of Iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.
3. It is also used as an iron replacement in adult patients with Iron Deficiency Anemia
Dosage & Administration
Hyperphosphatemia in Chronic Kidney Disease on Dialysis:
• Starting dose is 2 tablets orally 3 times per day with meals
• Adjust dose by 1 to 2 tablets as needed to maintain serum phosphorus at target levels, up to a maximum of 12 tablets
daily.Dose can be titrated at 1-week or longer intervals.
Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis:
• Starting dose is 1 tablet orally 3 times per day with meals
• Adjust dose as needed to achieve and maintain hemoglobin goal up to a maximum of 12 tablets daily
Side Effects
Most common adverse reactions (incidence ≥5%) are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia.
Precautions
• Iron overload: Monitor ferritin and TSAT. Patients may require a reduction in dose or discontinuation of intravenous Iron.
• Accidental overdose of Iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Use in Pregnancy & Lactation
Pregnancy: There are no available data on Ferric Citrate use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.
Lactation: There are no human data regarding the effect of Ferric Citrate in human milk, the effects on the breastfed child, or the effects on milk production.
Drug Interaction
Doxycycline and Ciprofloxacin cannot be concomitantly used with Ferric Citrate. Doxycycline should be administered 1 hour prior to Ferric Citrate and Ciprofloxacin should be administered 2 hour prior to Ferric Citrate administration.
Over Dose
No data are available regarding overdose of Ferric Citrate in patients. In patients with chronic kidney disease, the maximum dose studied was 2,520 mg Ferric Iron (12 tablets of Ferric Citrate) per day. Iron absorption from Ferric Citrate may lead to excessive elevations in Iron stores, especially when concomitant intravenous Iron is used. In clinical trials, one case of elevated Iron in the liver confirmed by biopsy reported in a patient on dialysis administered with intravenous Iron and Ferric Citrate.
Storage
Do not store above 30 °C. Keep away from light and out of the reach of children.
Commercial Pack
Citofer 210 mg tablet: Each box contains 5 blister strips of 6 tablets.
