Prescription Drug Information: Potassium Chloride (Page 2 of 2)

12.3 Pharmacokinetics

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.

Specific Populations


Cirrhotics


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.

13 NON CLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

17 PATIENT COUNSELING INFORMATION

  • 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.


Manufactured by:
APL Healthcare Limited
Unit-IV (MP SEZ),

SPSR Nellore (Dt)-524421

Andhra Pradesh, India

For BluePoint Laboratories
Issued: 08/2021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

NDC 68001-518-00
Rx only
Potassium Chloride Extended-Release Tablets, USP
10 mEq (750 mg) 100 Tablets

100 Tablet Label
(click image for full-size original)

POTASSIUM CHLORIDE potassium chloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-518
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 750 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (White to Off-white) Score no score
Shape ROUND (Circular, biconvex) Size 13mm
Flavor Imprint Code N;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-518-00 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-518-08 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210921 09/10/2021
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
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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