Potassium Chloride (Page 2 of 2)

10.2 Treatment

Treatment measures for hyperkalemia include the following:

  1. Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties.
  2. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
  3. Correction of acidosis, if present, with intravenous sodium bicarbonate.
  4. Use of exchange resins, hemodialysis or peritoneal dialysis.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.
The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

11 DESCRIPTION

Potassium chloride extended-release tablets USP are a solid oral dosage form of potassium chloride. Each contains 750 mg of potassium chloride equivalent to 10 mEq of potassium in a wax matrix tablet.
Potassium chloride extended-release tablets USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, crystalline powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and practically insoluble in ethanol.
Inactive Ingredients: Colloidal silicon dioxide, hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.


FDA approved acceptance criteria for assay differs from USP test.

Meets USP Dissolution Test 5.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.
The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.
Potassium is a normal dietary constituent and under steady state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.

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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