Tetraferric tricitrate decahydrate

Table 2: Oral drugs that can be administered concomitantly with Ferric Citrate Tablets Amlodipine Aspirin Atorvastatin Calcitriol Clopidogrel Digoxin Diltiazem Doxercalciferol Enalapril Fluvastatin Glimepiride Levofloxacin Losartan Metoprolol Pravastatin Propranolol Sitagliptin Warfarin Oral drugs that have to be separated from Ferric Citrate Tablets and meals Dosing Recommendations Doxycycline Take at least 1 hour before ferric citrate tablets Ciprofloxacin Take at least 2 hours before or after ferric citrate tablets Oral medications not listed in Table 2 There are no empirical data on avoiding drug interactions between ferric citrate tablets and most concomitant oral drugs.

For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separation of the timing of the administration of the two drugs. The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product. Consider monitoring clinical responses or blood levels of concomitant medications that have a narrow therapeutic range. When clinically significant drug interactions are expected, consider separation of the timing of administration.

Consider monitoring clinical responses or blood levels of the concomitant medication. ( 7 )

8.1 Pregnancy Risk Summary There are no available data on ferric citrate tablet use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted using ferric citrate tablets. Skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9. However, oral administration of other ferric or ferrous compounds to gravid CD1-mice and Wistar-rats caused no fetal malformation. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Clinical Considerations The effect of ferric citrate tablets on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy.