DRUG INTERACTIONS
Sevelamer carbonate has been studied in human drug-drug interaction
studies with warfarin and digoxin. Sevelamer hydrochloride, which contains the
same active moiety as sevelamer carbonate, has been studied in human drug-drug
interaction studies with ciprofloxacin, digoxin, warfarin, enalapril,
metoprolol and iron.
Ciprofloxacin
In a study of 15 healthy subjects, a co-administered single dose
of 2.8 grams of sevelamer hydrochloride decreased the bioavailability of
ciprofloxacin by approximately 50%.
Digoxin
In 19 healthy subjects receiving 2.4 grams of sevelamer
hydrochloride three times a day with meals for 2 days, sevelamer did not
alter the pharmacokinetics of a single dose of digoxin.
In 18 healthy subjects receiving 9.6 grams of sevelamer
carbonate once daily with a meal, sevelamer did not alter the
pharmacokinetics of a single dose of digoxin.
Warfarin
In 14 healthy subjects receiving 2.4 g of sevelamer
hydrochloride three times a day with meals for two days sevelamer did
not alter the pharmacokinetics of a single dose of warfarin.
In 14 healthy subjects receiving 9.6 grams of sevelamer
carbonate once daily with a meal, sevelamer did not alter the
pharmacokinetics of a single dose of warfarin.
Enalapril
In 28 healthy subjects a single 2.4 gram dose of sevelamer
hydrochloride did not alter the pharmacokinetics of a single dose of
enalapril.
Metoprolol
In 31 healthy subjects a single 2.4 gram dose of sevelamer
hydrochloride did not alter the pharmacokinetics of a single dose of
metoprolol.
Iron
In 23 healthy subjects, a single 2.8 gram dose of sevelamer
hydrochloride did not alter the absorption of a single oral dose of iron
as 200 mg exsiccated ferrous sulfate tablet.
Other Concomitant Drug Therapy
There are no empirical data on avoiding drug interactions
between Renvela and most concomitant drugs. During postmarketing
experience, very rare cases of increased thyroid stimulating hormone
(TSH) levels have been reported in patients co-administered sevelamer
hydrochloride and levothyroxine. Monitor TSH levels and signs of
hypothyroidism in patients receiving both medications.
When administering an oral medication where a reduction in the
bioavailability of that medication would have a clinically significant
effect on its safety or efficacy, there is no information that suggests a
dosing regimen that would be universally appropriate for all drugs. One
may, however, administer the drug one hour before or three hours after
Renvela, and monitor blood levels of the drug. Patients taking
anti-arrhythmic medications for the control of arrhythmias and
anti-seizure medications for the control of seizure disorders were
excluded from the clinical trials.
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