Sevelamer Carbonate For Oral Suspension (Page 4 of 4)
14.6 Sevelamer Hydrochloride versus Active-Control in Peritoneal Dialysis Patients
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 grams (range 0.8 to 14.3 grams). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active control group discontinued, mostly for gastrointestinal adverse reactions. 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.
14.7 Once-Daily versus Three-Times-Per-Day Dosing
Stage 5 CKD patients on hemodialysis with a serum phosphate level of > 5.5 mg/dl after washout from baseline therapies were randomized in a 2:1 ratio to receive either sevelamer carbonate powder once-daily (N=144) or sevelamer hydrochloride as a tablet with the dose divided three times per day (N=73) for 24 weeks. The initial dose for the two groups was 4.8 grams/day. At the end of the study, the total daily dose was 6.2 grams/day of sevelamer carbonate powder once daily and 6.7 grams/day of sevelamer hydrochloride tablets three times per day. A greater percentage of subjects on the once daily dose than three times-per-day regimen discontinued therapy prematurely, 35% versus 15%. The reasons for discontinuation were largely driven by adverse events and withdrawal of consent in the once daily dosing regimen. Serum phosphate levels and calcium-phosphate product were better controlled on the three times-per-day regimen than on the once-daily regimen. Mean serum phosphorus decreased 2 mg/dL for sevelamer carbonate powder once-daily and 2.9 mg/dL for sevelamer hydrochloride tablets three times per day.
16 HOW SUPPLIED/STORAGE AND HANDLING
Powder: Sevelamer carbonate for oral suspension is supplied as opaque, foil lined, heat sealed, packets containing 0.8 grams or 2.4 grams of sevelamer carbonate, colloidal silicon dioxide, iron oxide yellow, lemon spray dry flavour, mannitol, propylene glycol, PHA vanilla flavour, PHA orange flavour, and sucralose.
1 Box of 90 ct 0.8 grams packets NDC 43598-478-90
1 Box of 90 ct 2.4 grams packets NDC 43598-479-90
Storage: Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature]
Protect from moisture.
17 PATIENT COUNSELING INFORMATION
Dosing
Inform patients to take sevelamer carbonate for oral suspension with meals and adhere to their prescribed diets.
For patients using an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, advise the patient to take the oral medication at least one hour before or three hours after sevelamer carbonate.
For sevelamer carbonate powder, brief the patient on preparation of the powder in water.
Advise patients to report new onset or worsening of existing constipation or bloody stools promptly to their physician [see Warnings and Precautions (5.1)].
RX only
Distributor:
Dr. Reddy’s Laboratories Inc.,
Princeton NJ 08540, USA
Made in India
Issued: 0520
PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION
0.8 grams — Packet Label:
0.8 grams-Carton Label:
2.4 grams-Packet Label:
2.4 grams-Carton Label:
SEVELAMER CARBONATE FOR ORAL SUSPENSION sevelamer carbonate for oral suspension powder, for suspension | ||||||||||||||||||||
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SEVELAMER CARBONATE FOR ORAL SUSPENSION sevelamer carbonate for oral suspension powder, for suspension | ||||||||||||||||||||
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Labeler — Dr. Reddys Laboratories Inc (802315887) |
Establishment | |||
Name | Address | ID/FEI | Operations |
DR. REDDY’S LABORATORIES LIMITED (FTO-Sez-Process Unit-01) | 860037244 | analysis (43598-478), manufacture (43598-478), analysis (43598-479), manufacture (43598-479) |
Revised: 05/2020 Dr. Reddys Laboratories Inc
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