DESCRIPTION
id: d2c6b8ed-64a1-4192-a6bf-00bc68a6977e
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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 matrix tablet. This formulation is intended to provide an extended-release of potassium from the matrix to minimize the likelihood of producing high, localized concentrations of potassium within the gastrointestinal tract.
Potassium chloride 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.
USP Assay Test Pending.
CLINICAL PHARMACOLOGY
id: 082aa842-081e-49a8-8fed-c5ac64053db1
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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 mEq 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 slowly as a consequence of prolonged therapy with oral diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, severe diarrhea 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 be able to 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.
The potassium chloride in potassium chloride extended-release tablets is completely absorbed before it leaves the small intestine. The 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 is 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.
INDICATIONS AND USAGE
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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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 IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
- 1.For the therapeutic use 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.
- 2.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: 320cb70b-4258-4434-a955-72516a3693cb
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
).
Extended-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.
ADVERSE REACTIONS
id: 5c03252e-f99e-4d05-952d-c460de881c9a
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: 6342e9bc-543b-4049-9aaf-8b0fe21db5be
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 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 to 8 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).
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.
DOSAGE AND ADMINISTRATION
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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
The usual dietary potassium intake by the average adult is 50 mEq to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 mEq or more 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 mEq 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 provides 8 mEq or 10 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 must be swallowed whole and never crushed, chewed or sucked.
HOW SUPPLIED
id: cd0bc642-2e2b-400d-9c42-4ac21584c40e
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Potassium Chloride Extended-release Tablets, USP are available containing 600 mg of potassium chloride, USP (equivalent to 8 mEq) or 750 mg of potassium chloride, USP (equivalent to 10 mEq).
The 8 mEq (600 mg) tablet is a light brown film-coated, round, unscored tablet debossed with M on one side of the tablet and PC2 on the other side.
The 10 mEq (750 mg) tablet is a peach film-coated, round, unscored tablet debossed with M on one side of the tablet and PC1 on the other side. They are available as follows:
NDC 0615-7867-39
blistercards of 30 tablets
NDC 0615-7867-05
blistercards of 15 tablets
Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured in India by:
Mylan Laboratories Limited
Hyderabad—500 034, India
Code No. MH/DRUGS/25/NKD/89
REVISED OCTOBER 2013
MX:KCHLER:R2
75052349
PRINCIPAL DISPLAY PANEL – 10mEq
id: df01a2a6-7b7e-4221-b964-292f34dbfb62
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
