POTASSIUM CHLORIDE, EXTENDED – RELEASE TABLETS, USP

/POTASSIUM CHLORIDE, EXTENDED – RELEASE TABLETS, USP
POTASSIUM CHLORIDE, EXTENDED – RELEASE TABLETS, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

POTASSIUM CHLORIDE, EXTENDED – RELEASE TABLETS, USP

ID:

60c82f39-f0b1-52d2-e053-2a91aa0ac0d6

Code:

34391-3

DESCRIPTION


id: 60c82f39-f096-52d2-e053-2a91aa0ac0d6
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 600 mg, 750 mg and 1500 mg of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. The expended inert, porous, wax/polymer matrix is not absorbed and may be excreted intact in the stool. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as 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.

CLINICAL PHARMACOLOGY


id: 60c82f39-f098-52d2-e053-2a91aa0ac0d6
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and, in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine. If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long term diuretic therapy, supplemental potassium in the form of high potassium food or potassium chloride may restore normal potassium levels. In rare circumstances, (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

INDICATIONS AND USAGE


id: 60c82f39-f099-52d2-e053-2a91aa0ac0d6
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS, OR FOR PATIENTS WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern, and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and, if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases and if dose adjustment of the diuretic is ineffective or unwarranted supplementation with potassium salts may be indicated.

CONTRAINDICATIONS


id: 60c82f39-f09a-52d2-e053-2a91aa0ac0d6
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic, e.g., spironolactone, triamterene, or amiloride (see
OVERDOSAGE ).
Potassium chloride extended-release tablets are contraindicated in patients with known hypersensitivity to any ingredient in this product. Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation. All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological, e.g., diabetic gastroparesis, or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

WARNINGS


id: 60c82f39-f09b-52d2-e053-2a91aa0ac0d6
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Hyperkalemia (see OVERDOSAGE)
In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium intravenously, but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and can be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.

ADVERSE REACTIONS


id: 60c82f39-f0aa-52d2-e053-2a91aa0ac0d6
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

One of the most severe adverse effects is hyperkalemia (see
CONTRAINDICATIONS ,
WARNINGS , and
OVERDOSAGE ). There also have 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 taking the dose with meals, or reducing the amount taken at one time. Skin rash has been reported rarely.

OVERDOSAGE


id: 60c82f39-f0ab-52d2-e053-2a91aa0ac0d6
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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 intravenous administration is too rapid, 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 (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss P-waves, depression of S-T segments, and prolongation of the QT intervals). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).
Treatment measures for hyperkalemia include the following: Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties;
Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL;
Correction of acidosis, if present, with intravenous sodium bicarbonate;
Use of exchange resins, hemodialysis, or peritoneal dialysis.
In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, lowering the serum potassium concentration too rapidly 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


id: 60c82f39-f0ac-52d2-e053-2a91aa0ac0d6
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

The usual dietary potassium intake 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 40-100 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. Potassium chloride extended-release tablets provide 8 mEq, 10 mEq and 20 mEq of potassium chloride. 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 ).
NOTE: Potassium chloride extended-release tablets are to be swallowed whole without crushing, chewing or sucking the tablets.

HOW SUPPLIED


id: 60c82f39-f0ad-52d2-e053-2a91aa0ac0d6
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Potassium chloride extended-release tablets, USP contain 600 mg, 750 mg and 1500 mg of potassium chloride (equivalent to 8 mEq, 10 mEq and 20 mEq, respectively). Potassium chloride extended-release tablets, USP are provided as extended-release, film-coated tablets. Potassium chloride extended-release 600 mg (8 mEq) tablets are round in shape, yellow in color, debossed with the trademark K-TAB on one side, and are supplied as follows: Bottles of 100 – NDC 68382-776-01
Bottles of 1000 – NDC 68382-776-10
Potassium chloride extended-release 750 mg tablets (10 mEq) are ovaloid in shape, yellow in color, and are supplied and debossed as follows: Bottles of 100 – NDC 68382-320-01 (10 on one side and the trademark K‑TAB on the other side)
Bottles of 100 – NDC 68382-600-01 (the “a” logo on one side and the trademark K‑TAB on the other side)
Bottles of 1000 – NDC 68382-320-10 (10 on one side and the trademark K‑TAB on the other side)
Bottles of 1000 – NDC 68382-600-10 (the “a” logo on one side and the trademark K‑TAB on the other side)
Potassium chloride extended-release 1500 mg tablets (20 mEq) are ovaloid in shape, white in color, debossed with the trademark K-TAB on one side, and are supplied as follows: Bottles of 100 – NDC 68382-398-01
Bottles of 500 – NDC 68382-398-05