The potassium chloride in Potassium Chloride extended-release is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from the Potassium Chloride extended-release is compared to that of a true solution the extent of absorption is similar.
The extended-release properties of Potassium Chloride extended-release are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the Potassium Chloride extended-release dose as compared to the solution.
Increased urinary potassium excretion is first observed 1 hour after administration of Potassium Chloride extended-release, reaches a peak at approximately 4 hours, and extends up to 8 hours. Mean daily steady-state plasma levels of potassium following daily administration of Potassium Chloride extended-release tablets cannot be distinguished from those following administration of potassium chloride solution or from control plasma levels of potassium ion.
Based on publish literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load.
750 mg potassium chloride (equivalent to 10 mEq)
NDC 68071-5002-9 BOTTLES OF 90
Store at 25ºC (77ºF) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight container as defined in the USP with a child resistant closure.
- Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Inform patients that the wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool.
- Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed.
Strides Shasun Limited.
Bengaluru -562106, India.
Strides Pharma Inc.,
East Brunswick, NJ 08816
| POTASSIUM CHLORIDE |
potassium chloride tablet, extended release
|Labeler — NuCare Pharmaceuticals,Inc. (010632300)|
|NuCare Pharmaceuticals,Inc.||010632300||repack (68071-5002)|
Revised: 02/2021 NuCare Pharmaceuticals,Inc.
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