Sevelamer Hydrochloride (Page 4 of 4)

14.3 Active-Control, Parallel Study 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 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.

16. HOW SUPPLIED/STORAGE AND HANDLING

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.

17 PATIENT COUNSELING INFORMATION

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.
www.glenmarkpharma.com/usa

For questions about the packaging or labeling call American Health Packaging at 1-800-707-4621.

PACKAGING INFORMATION

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

Distributed by:
American Health Packaging Columbus, OH 43217

8444901/0221

Package/Label Display Panel – Carton – 800 mg

800 mg Sevelamer Hydrochloride Tablets Carton
(click image for full-size original)

NDC 60687- 449 -01

Sevelamer
Hydrochloride
Tablets

800 mg

100 Tablets (10 x 10)             Rx Only

Each Film-Coated Tablet Contains:
Sevelamer hydrochloride ……………………………………..800 mg

Usual Dosage: See package insert for full prescribing
information.

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
dry place.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 68462-447, Glenmark Pharmaceuticals Inc., USA.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

744901 0444901/0320

Package/Label Display Panel – Blister – 800 mg

800 mg Sevelamer Hydrochloride Tablet Blister
(click image for full-size original)

Sevelamer Hydrochloride Tablet

800 mg

SEVELAMER HYDROCHLORIDE sevelamer hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-449(NDC:68462-447)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER HYDROCHLORIDE (SEVELAMER) SEVELAMER HYDROCHLORIDE 800 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
DIACETYLATED MONOGLYCERIDES
HYPROMELLOSE, UNSPECIFIED
HYPROMELLOSE 2910 (50 MPA.S)
LACTOSE MONOHYDRATE
STARCH, CORN
MANNITOL
TALC
ZINC STEARATE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
SHELLAC
Product Characteristics
Color white (off-white to pale yellow) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code G447
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-449-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-449-11)
1 NDC:60687-449-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-449-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204724 10/01/2019
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-449)

Revised: 01/2022 American Health Packaging

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