The potassium chloride in potassium chloride extended-release tablets are 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 tablets are compared to that of a true solution the extent of absorption is similar.
The extended-release properties of potassium chloride extended-release tablets 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 tablets dose as compared to the solution.
Increased urinary potassium excretion is first observed 1 hour after administration of potassium chloride extended-release tablets, 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.
Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.
Potassium Chloride Extended-Release Tablets USP contains 750 mg of potassium chloride equivalent to 10 mEq. Potassium chloride is provided as extended-release tablets.
Potassium Chloride Extended-Release Tablets USP 750 mg (10 mEq) are white to off-white, circular, film-coated biconvex tablet debossed with “N 32” on one side and plain on other side.
Bottles of 100 NDC 68001-518-00
Bottles of 1,000 NDC 68001-518-08
Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container 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.
APL Healthcare Limited
Unit-IV (MP SEZ),
SPSR Nellore (Dt)-524421
Andhra Pradesh, India
For BluePoint Laboratories
|POTASSIUM CHLORIDE potassium chloride tablet, film coated, extended release|
|Labeler — BluePoint Laboratories (985523874)|
|APL HEALTHCARE LIMITED||650918514||analysis (68001-518), analysis (68001-518), manufacture (68001-518), manufacture (68001-518)|
Revised: 09/2021 BluePoint Laboratories
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