Klor-Con® 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. 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.

Klor-Con® 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.

Inactive Ingredients: Castor oil, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, polyethylene glycol 3350, propylene glycol, silicon dioxide and titanium dioxide. Yellow tablets also contain D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake. Blue tablets also contain FD&C Blue No. 1 aluminum lake. The tablets are imprinted using a pharmaceutical ink.

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.

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 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- 10 0 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 Klor-Con® Extended-release Tablet provides 8 mEq or 10 mEq of potassium chloride.

Klor-Con® (Potassium Chloride Extended-release Tablets, USP) 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: Klor-Con® Extended-release Tablets must be swallowed whole and never crushed, chewed or sucked.

Film-coated Klor-Con® 8 (blue), Klor-Con® 10 (yellow), imprinted round tablets containing:

600 mg potassium chloride (equivalent to 8 mEq) in bottles of 100 (NDC 0245- 0040-11), bottles of 500 (NDC 0245-0040-15), unit dose packages of 100 (NDC 0245-0040-01) and bulk packs of 5,000 for repack only (NDC 0245-0040-55); 750 mg potassium chloride (equivalent to 10 mEq) in bottles of 100 (NDC 0245- 0041-11), bottles of 500 (NDC 0245-0041-15), unit dose packages of 100 (NDC 0245-0041-01) and bulk packs of 5,000 for repack only (NDC 0245-0041-55).

Store at controlled room temperature, 15-30°C (59-86°F). Protect from light and moisture. Dispense in a tight container with child-resistant closure.

Manufactured by UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447. Revised 0105. FDA Rev date: 4/13/2006

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.

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

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 by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and 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.

Interaction with Potassium-sparing Diuretics: Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene or amiloride), since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin Converting Enzyme Inhibitors: Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions: Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of potassium chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to extended-release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Klor-Con® (Potassium Chloride Extended-release Tablets, USP) are wax matrix tablets formulated to provide an extended rate of release of potassium chloride and thus to minimize the possibility of high local concentration of potassium near the gastrointestinal wall.

Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after one week of solid oral potassium chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix extended-release formulation under conditions which did not resemble usual or recommended clinical practice (i.e., 96 mEq per day in divided doses of potassium chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (hemoccult testing). The relevance of these findings to the usual conditions (i.e., non-fasting, no anticholinergic agent, smaller doses) under which extended-release potassium chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. Klor-Con® (Potassium Chloride Extended-release Tablets, USP) should be discontinued immediately and the possibility of ulceration, obstruction or perforation considered if severe vomiting, abdominal pain, distention or gastrointestinal bleeding occurs.

Metabolic Acidosis: Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate or potassium gluconate.

General: The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should be aware that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram and the clinical status of the patient.

Laboratory Tests: When blood is drawn for analysis of plasma potassium it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with Klor-Con® Extended-release Tablets. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers: The normal potassium ion content of human milk is about 13 mEq per liter. It is not known if Klor-Con® Extended-release Tablets have an effect on this content. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use: Safety and effectiveness in the pediatric population have not been established.

Geriatric Use: Clinical studies of Klor-Con® Extended-release Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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 (6.5-8.0 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 (9-12 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 10-20 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.

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.

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 10 0 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 Klor-Con® Extended-release Tablets 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 bioavailabilty of the potassium ion from the Klor-Con® Extended-release Tablets is compared to that of a true solution the extent of absorption is similar. The extended-release properties of Klor-Con® 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 Klor-Con® Extended-release Tablets dose as compared to the solution.

Increased urinary potassium excretion is first observed 1 hour after administration of Klor-Con® 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 Klor-Con® Extended-release Tablets cannot be distinguished from those following administration of potassium chloride solution from control plasma levels of potassium ion.

Physicians should consider reminding the patient of the following: To take each dose with meals and with a full glass of water or other liquid. To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.

To check with the physician if there is trouble swallowing the tablets or if the tablets seem to stick in the throat.

To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed. To take each dose without crushing, chewing or sucking the tablets.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

POTASSIUM CHLORIDE - ORAL

(poh-TASS-ee-um KLOR-ide)

USES: This medication is a mineral supplement used to prevent or treat low amounts of potassium in the blood. A normal level of potassium in the blood is important so that your cells, nerves, heart, muscles, and kidneys work properly. Normal blood levels of potassium are usually achieved by eating a well-balanced diet. However, certain situations cause your body to lose potassium faster than you can replace it from your diet. These situations include treatment with certain "water pills" (diuretics), a poor diet, or certain medical conditions (e.g., severe diarrhea especially with vomiting).

HOW TO USE: Take this medication by mouth as directed by your doctor. To prevent stomach upset, take each dose with a meal and a full glass (8 ounces or 240 milliliters) of water unless your doctor directs you otherwise. Do not lie down for 30 minutes after taking this medication. If your total daily dosage is more than 20 milliequivalents, your doctor may direct you to divide the daily dose so that you take smaller amounts of medication several times a day, but do not take more than 20 milliequivalents as a single dose. This will also help to reduce stomach upset.

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time(s) each day. Dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more often than prescribed. Too much potassium in the blood can cause serious side effects.

Sustained-release capsules and tablets must be swallowed whole. Do not crush, chew, or suck the pills because this may increase side effects.

If you have trouble swallowing the capsules, ask your doctor or pharmacist about certain brands that may be opened up and the contents sprinkled onto a spoonful of cool, soft food such as applesauce or pudding. Swallow the food/medication mixture immediately without chewing. Do not prepare the mixture ahead of time. Drink a glass of cool water after each dose to make sure you swallow all the medication.

Inform your doctor if symptoms of low potassium blood levels (e.g., muscle cramps/weakness, tiredness, irregular heartbeat) persist or worsen.

SIDE EFFECTS: Stomach pain/upset, nausea, vomiting, or diarrhea may occur. See How to Use for ways to reduce stomach upset. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

For some capsule forms of this medication, an empty capsule shell may appear in your stool. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: difficult/painful swallowing, feeling as if the capsule/tablet is stuck in your throat.

Tell your doctor immediately if any of these rare but very serious side effects occur: vomit that looks like coffee grounds, stomach/abdominal pain or swelling, black/tarry stools.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking potassium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high potassium blood levels, severe kidney disease (e.g., chronic kidney failure, inability to make urine), adrenal gland problems, severe conditions of tissue breakdown (e.g., severe burns, traumatic injury).

Due to rare reports of stomach/intestinal ulcers and bleeding with sustained-release potassium chloride products, the capsules/tablets should be used only in patients who cannot take liquid or effervescent potassium forms. Patients with blockage/narrowing/slowed movement of the esophagus/stomach/intestines (e.g., diabetic gastroparesis, esophageal compression due to an enlarged heart) are at greater risk for these side effects and should use liquid or effervescent potassium forms.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, certain types of heart disease (e.g., atrioventricular block), stomach ulcers.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to the effects of this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Potassium passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before taking potassium supplements, check with your doctor if you are taking other medications/products that may also increase the potassium level in your blood. A potassium level in the blood that is too high may cause serious side effects. Follow your doctor's instructions carefully and continue medications for your condition as directed. Keep all medical/laboratory appointments so your doctor can monitor your potassium levels. Consult with your doctor if you are taking any of the following: ACE inhibitors (e.g., captopril, lisinopril), angiotensin receptor blockers (ARBs such as candesartan, losartan), eplerenone, potassium-sparing "water pills" (diuretics such as amiloride, spironolactone, triamterene), salt substitutes containing potassium.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: digoxin, drospirenone, "water pills" (diuretics such as furosemide, hydrochlorothiazide).

Also tell your doctor or pharmacist if you take medications that may slow down the movement of potassium capsules/tablets in your digestive system, possibly increasing the risk of side effects. These drugs include: anticholinergic drugs (e.g., atropine, scopolamine), certain antihistamines (e.g., diphenhydramine), antispasmodic drugs (e.g., dicyclomine, hyoscyamine), certain anti-Parkinson's drugs (e.g., benztropine, trihexyphenidyl), belladonna alkaloids, bladder control drugs (e.g., oxybutynin, tolterodine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include irregular heartbeat, muscle weakness, confusion, numbness/tingling of the hands/feet, chest pain.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., potassium blood level, kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Eat a well-balanced diet. Foods high in potassium include: bananas, oranges, watermelon, cantaloupe, raisins, dates, prunes, avocados, apricots, beans, broccoli, leafy green vegetables, spinach, potatoes, lentils, fish, chicken, turkey, ham, beef, and milk. Consult your doctor or pharmacist regarding your specific dietary plan.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.