One hundred and forty-three patients on peritoneal dialysis, who were hyperphosphatemic (serum phosphorus > 5.5 mg/dL) following a two-week phosphate binder washout period, were randomized to receive sevelamer hydrochloride (N=97) or active-control (N=46) open label for 12 weeks. Average daily sevelamer hydrochloride dose at the end of treatment was 5.9 g (range 0.8 to 14.3 g). There were statistically significant changes in serum phosphorus (p<0.001) for sevelamer hydrochloride (-1.6 mg/dL from baseline of 7.5 mg/dL), similar to the active-control.
Sevelamer Hydrochloride Tablets, 800 mg, are supplied as off-white to pale yellow, modified capsule shaped, biconvex film coated tablets, imprinted with ‘G447’ on one side and plain on the other side and are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-449-01
Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Do not use sevelamer hydrochloride tablets after the expiration date.
Protect from moisture and store in a dry place.
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Advise patients to take sevelamer hydrochloride tablets with meals and adhere to their prescribed diets.
Provide instructions on concomitant medications that should be dosed apart from sevelamer hydrochloride tablets.
Advise patients to report new onset or worsening of existing constipation or bloody stools promptly to their healthcare provider [see Warnings and Precautions (5.1)].
For questions about the drug product call Glenmark Pharmaceuticals Inc., USA at 1-888-721-7115.
For questions about the packaging or labeling call American Health Packaging at 1-800-707-4621.
American Health Packaging unit dose blisters (see
How Supplied section) contain drug product from Glenmark Pharmaceuticals Inc., USA as follows:
(800 mg / 100 UD) NDC 60687-449-01 packaged from NDC 68462-447
American Health Packaging Columbus, OH 43217
NDC 60687- 449 -01
100 Tablets (10 x 10) Rx Only
Each Film-Coated Tablet Contains:
Sevelamer hydrochloride ……………………………………..800 mg
Usual Dosage: See package insert for full prescribing
Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Protect from moisture and store in a
Keep this and all drugs out of reach of children.
FOR YOUR PROTECTION: Do not use if blister is torn or
The drug product contained in this package is from
NDC # 68462-447, Glenmark Pharmaceuticals Inc., USA.
American Health Packaging
Columbus, Ohio 43217
Sevelamer Hydrochloride Tablet
|SEVELAMER HYDROCHLORIDE sevelamer hydrochloride tablet, film coated|
|Labeler — American Health Packaging (929561009)|
|American Health Packaging||929561009||repack (60687-449)|
Revised: 01/2022 American Health Packaging
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