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,
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, 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 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 when important, 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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