Sevelamer carbonate

Sevelamer carbonate.

In human drug interaction studies, drug interactions between sevelamer carbonate and warfarin and digoxin were studied. Interactions between sevelamer hydrochloride (containing the same active ingredient as sevelamer carbonate) and ciprofloxacin, digoxin, warfarin, enalapril, metoprolol, and iron were studied. (See instructions for details)

The main ingredient of this product is sevelamer carbonate.

In human drug interaction studies, drug interactions between sevelamer carbonate and warfarin and digoxin were studied. The interactions between sevelamer hydrochloride (containing the same active ingredient as sevelamer carbonate) and ciprofloxacin, digoxin, warfarin, enalapril, metoprolol, and iron were studied. 1. Ciprofloxacin: In a study with 15 healthy subjects, the co-administration of a single dose of 2.8 g of sevelamer hydrochloride reduced the bioavailability of ciprofloxacin by approximately 50%. Therefore, this product should not be taken with ciprofloxacin. 2. Digoxin: (1) 19 healthy subjects received 2.4 g of sevelamer hydrochloride three times a day with meals for 2 days. Sevelamer did not change the pharmacokinetics of a single dose of digoxin. (2) 18 healthy subjects received 9.6 g of sevelamer carbonate once a day with meals. Sevelamer did not change the pharmacokinetics of a single dose of digoxin. 3. Warfarin: (1) 14 healthy subjects received 2.4 g of sevelamer hydrochloride three times a day with meals for 2 days. Sevelamer did not change the pharmacokinetics of a single dose of warfarin. (2) 14 healthy subjects received 9.6 g of sevelamer carbonate once a day with meals. Sevelamer did not change the pharmacokinetics of a single dose of warfarin. 4. Enalapril: 28 healthy subjects received a single dose of 2.4 g of sevelamer hydrochloride. Sevelamer hydrochloride did not change the pharmacokinetics of a single dose of enalapril. 5. Metoprolol: 31 healthy subjects received a single dose of 2.4 g of sevelamer hydrochloride. Sevelamer hydrochloride did not change the pharmacokinetics of a single dose of metoprolol. 6. Iron: 23 healthy subjects received a single dose of 2.8 g of sevelamer hydrochloride. Sevelamer hydrochloride did not change the absorption of iron ions in a single dose of 200 mg dry ferrous sulfate tablets. 7. Combined treatment with it: ① No empirical data have been obtained on avoiding interactions between sevelamer carbonate and most combined drugs. After sevelamer carbonate was marketed, there have been reports of elevated thyroid stimulating hormone (TSH) levels in patients receiving sevelamer hydrochloride and levothyroxine at the same time, but this is extremely rare. Patients receiving these two drugs need to monitor serum levels of TSH and signs of hypothyroidism. ② When the reduced bioavailability of an oral drug has a significant clinical impact on its safety and efficacy, there is no dosing information applicable to all drugs. However, the drug should be taken at least one hour before or three hours after taking sevelamer carbonate, and the blood concentration of the drug should be monitored. ③ In clinical trials, patients taking antiarrhythmic drugs to control arrhythmias and antiepileptic drugs to control epileptic disorders were excluded from the study. Therefore, special caution should be used when administering sevelamer carbonate to patients taking such drugs at the same time. ④ In organ transplant patients, when used simultaneously with this product, the blood concentrations of cyclosporine, mycophenolate mofetil and tacrolimus were observed to decrease, but no relevant clinical consequences (i.e. transplant rejection) were observed. However, the possibility of drug interactions cannot be ruled out, so when these drugs are used simultaneously and after this product is discontinued, regular monitoring of the blood concentrations of cyclosporine, mycophenolate mofetil and tacrolimus should be considered.