Get your patient on Potassium Chloride Extended - Release - Potassium Chloride tablet, Extended Release (Potassium Chloride)

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 IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

1. 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.
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.

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 40-100 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, USP, 10 mEq provides 10 mEq of potassium chloride.

Potassium Chloride Extended Release Tablets, USP, 10mEq 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 1/2 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 1 fluid ounce of water, swirl, and consume immediately.
   6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of Potassium Chloride Extended Release Tablets, USP, 10mEq that is not taken immediately should be discarded. The use of other liquids for suspending Potassium Chloride Extended Release Tablets, USP, 10mEq is not recommended.

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, amiloride) (see OVERDOSAGE ).

Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Potassium Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).

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.

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.

Call your doctor for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact the manufacturer Adare at 1-877-731-5116 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS ).

The Potassium Chloride Extended Release Tablets, USP, 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a 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.

Potassium Chloride Extended Release Tablets, USP, 10mEq are an electrolyte replenisher. The chemical name of the active ingredient 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.

Potassium Chloride Extended Release Tablets, USP, 10mEq are a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration.

In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets, USP, 10 mEq begin disintegrating into micro-encapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride.

FDA approved dissolution test specifications differ from USP.

Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethylcellulose, microcrystalline cellulose.

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.

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 or 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.

Potassium Chloride Extended Release Tablets, USP, 10mEq are available in bottles of 100 tablets (NDC 63304-076-01), bottles of 500 tablets (NDC 63304-076-05) and bottles of 1000 tablets (NDC 63304-076-10).

Potassium Chloride Extended Release Tablets, USP, 10mEq are capsule shaped, white to off-white tablets, with “Q10” imprinted on one side and plain on the other side.

Storage Conditions: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Contains: MICROCAPS drug delivery product.

Manufactured by:

Adare Pharmaceuticals, Inc.

Vandalia, OH 45377 USA

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Iss. 07/2019

MICROCAPS is a registered trademark of Adare Pharmaceuticals S.r.l., an affiliate of Adare Pharmaceuticals, Inc.