Potassium Chloride (Page 2 of 2)

10 OVERDOSAGE

10.1 Symptoms

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, 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 to 8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 to 12 mEq/L).

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 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 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, 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 Type 1, Ethylcellulose (10cP), Ethylcellulose (100cP), Silicon Dioxide, Talc, Magnesium Stearate. The 600 mg tablets also contain Polyvinyl Alcohol, Titanium dioxide, Macrogol / PEG, Talc, FD&C Blue #1 / Brilliant Blue FCF Aluminum Lake, FD&C Blue #2 / Indigo Carmine Al 3% — 5% and the 750 mg tablets also contain of Polyvinyl Alcohol, Titanium dioxide, Macrogol / PEG, Talc, FD&C Yellow #5 / Tartrazine Aluminum Lake and FD&C Yellow #6 / Sunset Yellow FCF Aluminum Lake.

“FDA approved dissolution test specifications differ from USP.” and “FDA approved acceptance criteria for assay differs from USP test.”

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 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 Potassium Chloride extended-release is compared to that of a true solution the extent of absorption is similar.

The extended-release properties of Potassium Chloride extended-release 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 dose as compared to the solution.

Increased urinary potassium excretion is first observed 1 hour after administration of Potassium Chloride 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 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 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

750 mg potassium chloride (equivalent to 10 mEq)

NDC 68071-5002-9 BOTTLES OF 90

Store at 25ºC (77ºF) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight container as defined in the USP 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

Strides Shasun Limited.

Bengaluru -562106, India.

Distributed by:

Strides Pharma Inc.,

East Brunswick, NJ 08816

Revised 08/2018

PRINCIPAL DISPLAY PANEL

PDP
(click image for full-size original)

POTASSIUM CHLORIDE
potassium chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5002(NDC:64380-861)
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
ETHYLCELLULOSE (10 MPA.S)
ETHYLCELLULOSE (100 MPA.S)
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
HYDROGENATED COTTONSEED OIL
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND (biconvex) Size 12mm
Flavor Imprint Code P10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-5002-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210733 08/31/2018
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-5002)

Revised: 02/2021 NuCare Pharmaceuticals,Inc.

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