Potassium Chloride (Page 2 of 2)

ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS and OVERDOSAGE). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS). The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.

OVERDOSAGE

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 mEq/L to 8 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 mEq/L to 12 mEq/L).

Treatment measures for hyperkalemia include the following:

1.
Patients should be closely monitored for arrythmias and electrolyte changes.
2.
Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDs, certain nutritional supplements and many others.
3.
Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
4.
Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
5.
Correction of acidosis, if present, with intravenous sodium bicarbonate.
6.
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.

DOSAGE AND ADMINISTRATION

The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

Each potassium chloride extended-release tablet 20 mEq provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium.

Each potassium chloride extended-release tablet 10 mEq provides 750 mg of potassium chloride equivalent to 10 mEq of potassium.

Potassium chloride extended-release tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS).

Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:

1. Break the tablet in half and take each half separately with a glass of water.

2. Prepare an aqueous (water) suspension as follows:

1. Place the whole tablet(s) in approximately one-half glass of water (4 fluid ounces).

2. Allow approximately 2 minutes for the tablet(s) to disintegrate.

3. Stir for about half a minute after the tablet(s) has disintegrated.

4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.

5. Add another one fluid ounce of water, swirl, and consume immediately.

6. Then, add an additional one fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of potassium chloride extended-release tablet that is not taken immediately should be discarded. The use of other liquids for suspending potassium chloride extended-release tablets is not recommended.

HOW SUPPLIED

Potassium chloride extended-release tablets USP 20 mEq K are supplied as oblong white to off-white colored, scored for flexibility of dosing, debossed “P 20” on one side and bisected on other side.

Carton of 80 tablets (10 tablets per blister pack x 8), NDC 0904-7086-45

Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7086-61

Potassium chloride extended-release tablets USP 10 mEq K are supplied as oblong, white to off-white colored tablets, debossed “P 10” on one side and plain on other side.

Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7085-61

Keep tightly closed. Store at 20o to 25o C (68o to 77o F); excursions permitted between 15o to 30o C (59o to 86o F) [See USP Controlled Room Temperature].

Manufactured by:

Novel Laboratories, Inc

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals, Inc

Baltimore, MD 21202

Distributed By:

MAJORĀ® PHARMACEUTICALS

Livonia, MI 48152

Refer to package label for Distributor’s NDC Number

PI9170000202

Revised: 11/2016

Package/Label Display Panel

Potassium Chloride ER

10 mEq K

100 Tablets

carton label
(click image for full-size original)

Package/Label Display Panel

Potassium Chloride ER 20 mEq

20 mEq

100 Tablets

carton label
(click image for full-size original)
POTASSIUM CHLORIDE
potassium chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7085(NDC:43386-915)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 10 meq
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
ETHYLCELLULOSE (45 MPA.S)
TRIETHYL CITRATE
ALCOHOL
ISOPROPYL ALCOHOL
Product Characteristics
Color WHITE (to of white) Score no score
Shape OVAL (Oblong) Size 17mm
Flavor Imprint Code P10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7085-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0904-7085-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206347 01/21/2016
POTASSIUM CHLORIDE
potassium chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7086(NDC:43386-917)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 20 meq
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
ETHYLCELLULOSE (45 MPA.S)
TRIETHYL CITRATE
ALCOHOL
ISOPROPYL ALCOHOL
Product Characteristics
Color WHITE (to of white) Score 2 pieces
Shape OVAL (Oblong) Size 22mm
Flavor Imprint Code P20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7086-45 80 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0904-7086-45)
2 NDC:0904-7086-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0904-7086-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206347 01/21/2016
Labeler — Major Pharmaceuticals (191427277)

Revised: 05/2021 Major Pharmaceuticals

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