KLOR-CON (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 mL/hr 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

Klor-Con® extended-release tablets are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet.

Klor-Con® extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular 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 insoluble in alcohol.

Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide. Yellow tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Blue tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake.

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 mEq to 160 mEq per liter. The normal adult plasma concentration is 3.5 mEq 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 Klor-Con 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 Klor-Con extended-release is compared to that of a true solution the extent of absorption is similar.

The extended-release properties of Klor-Con extended-release are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the Klor-Con extended-release dose as compared to the solution.

Increased urinary potassium excretion is first observed 1 hour after administration of Klor-Con 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 Klor-Con 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 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis and 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

Klor-Con (potassium chloride, USP) contains 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq potassium respectively). Klor-Con is provided as extended- release tablets.

Table 1: How Supplied
Dose Shape Color Debossment NDC#:66758-xxx-xx
Bottle of 100 Tablets Bottle of 500 Tablets Carton of 100 Unit-Dose Tablets
600 mg (8 mEq) round light blue “KC 8” 110-01 110-05 110-13
750 mg (10 mEq) round yellow “KC 10” 060-01 060-05 060-13

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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.

Klor-Con is a registered trademark of Upsher-Smith Laboratories, LLC.

Manufactured by
Upsher-Smith Laboratories, LLC
Maple Grove, MN 55369 for
Sandoz Inc., Princeton, NJ 08540

Revised: May, 2018

PRINCIPAL DISPLAY PANEL — 600 mg Tablet Bottle Label

NDC 66758-110-01

Klor-Con® 8
(potassium chloride
extended-release
tablets, USP)

8 mEq (600 mg)

Rx Only

100 Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL -- 600 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 750 mg Tablet Bottle Label

NDC 66758-160-01

Klor-Con® 10
(potassium chloride
extended-release
tablets, USP)

10 mEq (750 mg)

Rx Only

100 Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL -- 750 mg Tablet Bottle Label
(click image for full-size original)
KLOR-CON
potassium chloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66758-110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
potassium chloride (Potassium cation) potassium chloride 600 mg
Inactive Ingredients
Ingredient Name Strength
hydrogenated cottonseed oil
magnesium stearate
polyethylene glycol, unspecified
polyvinyl alcohol, unspecified
silicon dioxide
talc
titanium dioxide
FD&C blue no. 1
FD&C blue no. 2
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code KC;8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66758-110-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (66758-110-06)
1 NDC:66758-110-06 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (66758-110-13)
2 NDC:66758-110-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:66758-110-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019123 09/01/2014 09/30/2021
KLOR-CON
potassium chloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66758-160
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
hydrogenated cottonseed oil
magnesium stearate
polyethylene glycol, unspecified
polyvinyl alcohol, unspecified
silicon dioxide
talc
titanium dioxide
D&C yellow no. 10
FD&C yellow no. 6
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 13mm
Flavor Imprint Code KC;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66758-160-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (66758-160-06)
1 NDC:66758-160-06 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (66758-160-13)
2 NDC:66758-160-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:66758-160-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019123 09/01/2014 01/31/2022
Labeler — Sandoz Inc. (005387188)
Registrant — Upsher-Smith Laboratories, Inc. (079111820)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories, LLC 079111820 MANUFACTURE (66758-110), MANUFACTURE (66758-160)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories, LLC 047251004 ANALYSIS (66758-110), ANALYSIS (66758-160)

Revised: 11/2020 Sandoz Inc.

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