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Potassium Chloride Extended Release Tablets, USP
The Potassium Chloride Extended Release Tablets, USP 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet.
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 is 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 is 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 out-side agitation, Potassium Chloride Tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride.
Inactive Ingredients: Crospovidone, Ethylcellulose, Hydroxypropyl Cellulose, Magnesium Stearate, and Microcrystalline Cellulose.
Last updated on RxList: 9/8/2008
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.
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 20 mEq provides 20 mEq of potassium chloride.
Each Potassium Chloride Extended Release Tablet, USP 10 mEq 10 tablet provides 10 mEq of potassium chloride.
Potassium Chloride 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).
Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:
Aqueous suspension of Potassium Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassium Chloride Tablets is not recommended.
Potassium Chloride Extended Release Tablets, USP 20mEq are available in bottles of 100 (NDC 0085-0787-01); bottles of 500 (NDC 0085-0787-06); bottles of 1000 (NDC 0085-0787-10); and boxes of 100 for unit dose dispensing (NDC 0085- 0787-81).
Potassium Chloride Extended Release Tablets, USP 20 mEq are white to off-white capsule-shaped tablets imprinted W-1714 and scored on the other side.
Potassium Chloride Extended Release Tablets, USP 10mEq are available in bottles of 100 (NDC 0085-0263-01) and boxes of 100 for unit dose dispensing (NDC 0085-0263-81). Potassium Chloride Extended Release Tablets, USP 10mEq are white to off-white capsule-shaped tablets imprinted W-1715 on one side and plain on the other side.
Storage Conditions: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]
Schering Corporation, Kenilworth, NJ 07033 USA. Rev. 8/06. FDA rev date: 6/13/2008
Last updated on RxList: 9/8/2008
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.
Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS).
Last updated on RxList: 9/8/2008
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 (eg, 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 (eg, 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 sustained 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. Potassium Chloride is a tablet formulated to provide a controlled rate of release of microencapsulated potassium chloride and thus to minimize the possibility of a 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 1 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 controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (ie, 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 (ie, non-fasting, no anticholinergic agent, smaller doses) under which controlled-release potassium chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to micro-encapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. Potassium Chloride Extended Release Tablets should be discontinued immediately and the possibility of ulceration, obstruction, or perforation should be 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 bear in mind 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 Category C: Animal reproduction studies have not been conducted with Potassium Chloride. 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. 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 pediatric patients have not been established.
Geriatric Use: Clinical studies of Potassium Chloride 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.
Last updated on RxList: 9/8/2008
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-waves, 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:
Patients should be closely monitored for arrythmias and electrolyte changes.
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 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 (eg, 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.
Last updated on RxList: 9/8/2008
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, eg, 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 (eg, 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.
Last updated on RxList: 9/8/2008
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 each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration:
Aqueous suspension of Potassium Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassium Chloride Tablets is not recommended.
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 at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.
Last updated on RxList: 9/8/2008
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 EXTENDED-RELEASE TABLET - ORAL
(poh-TASS-ee-um KLOR-ide)
COMMON BRAND NAME(S): K-Dur, Klor-Con M
USES: This medication is used to treat and prevent low potassium levels (hypokalemia). Potassium is a natural mineral found in the body and in various foods. Normal potassium levels are necessary for proper functioning of the muscles, heart, kidneys, and nerves. This medication is a potassium supplement that works by increasing or maintaining normal levels of potassium in your body.
This medication should only be used in persons who cannot take other forms of potassium (liquid, effervescent tablets).
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Potassium chloride may be helpful in the treatment of high blood pressure. It is also used to treat abnormal heart rhythms that may occur from certain drugs (digitalis).
HOW TO USE: Take this medication by mouth, with food, as directed by your doctor.
Take with a full glass of water or other liquid (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 30 minutes after taking this medication. Do not take this medication on an empty stomach.
Swallow this medication whole. Do not chew or suck on the tablets. Doing so may cause side effects.
If you have difficulty swallowing whole tablets, you may break the tablet in half and take each half separately, drinking half a glass (4 ounces or 120 milliliters) of water after each half-tablet. Take your entire dose within a few minutes. You may also dissolve the whole tablet in half a glass (4 ounces or 120 milliliters) of water. Allow about 2 minutes for the tablet to dissolve, then stir the mixture for 30 seconds and drink it immediately. Use a straw if desired. Add 1 more ounce (30 milliliters) of water to the glass, swirl, and drink immediately. Repeat one more time to make sure you are getting all of the drug. Do not save the mixture for future use. Do not use a liquid other than water for mixing this drug.
Dosage is based on your medical condition, blood potassium levels, and response to therapy.
Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or take it more often than prescribed.
Inform your doctor if your condition persists or worsens.
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.
This drug may cause serious stomach or intestinal problems (e.g., bleeding, blockage, puncture). Tell your doctor immediately if any of these unlikely but serious side effects occur: black/bloody stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, dizziness, constipation, abdominal swelling.
This medication may cause high potassium levels in the blood (hyperkalemia). Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle cramps/weakness, severe dizziness, confusion, tingling of the hands/feet, slow/irregular heartbeat, unusually cold skin.
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: See also Side Effects section.
Before taking this medication, 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 blood potassium levels (hyperkalemia), certain stomach/intestinal problems (diabetic gastroparesis, conditions decreasing gut movement), certain heart problems (enlarged left atrium, atrioventricular block), a certain muscle problem (hyperkalemic periodic paralysis).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems, kidney problems (e.g., chronic renal failure, renal tubular acidosis), heat cramps, a sudden severe loss of body water (dehydration), severe tissue damage (e.g., severe burns), stomach/intestinal ulcer, metabolic problems (e.g., metabolic acidosis, diabetic acidosis), a adrenal gland problem (Addisons disease).
You may be at risk for low potassium levels (hypokalemia) from your condition if the dosage of this medication is too low, if you take certain drugs (e.g., water pills/diuretics such as furosemide), or if you do not get enough potassium from food. Tell your doctor immediately if you notice any of these unlikely but very serious symptoms of low potassium: muscle cramps/weakness, irregular heartbeat, or unusual tiredness.
Consult your doctor or pharmacist for more details.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults 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.
This drug passes into breast milk. There have been no reports of harm to nursing infants when the mothers blood potassium levels are in the normal range. Consult your doctor before breast-feeding.
This drug should not be used with the following medications because very serious interactions may occur: drugs that slow the movement of food/drugs through the esophagus/stomach (e.g., anticholinergics such as belladonna/scopolamine/benztropine, antispasmodics such as glycopyrrolate/oxybutynin, potent narcotic pain medicines such as morphine).
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting potassium chloride.
This medication increases your potassium levels. Using this product with other medications or products that increase your potassium levels may cause very serious side effects.
Before using this medication, tell your doctor or pharmacist of prescription and nonprescription/herbal products you may use, especially: ACE inhibitors (e.g., captopril and enalapril), drugs with anticholinergic effects (e.g., certain antihistamines such as diphenhydramine, tricyclic antidepressants such as amitriptyline), eplerenone, potassium-sparing water pills/diuretics (e.g., amiloride, spironolactone, triamterene), potassium-containing products (salt substitutes).
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: muscle cramps/weakness, severe dizziness, confusion, tingling of the hands or feet, slow/irregular heartbeats, unusually cold skin.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (e.g., potassium blood levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Eating potassium-rich foods may help to prevent low potassium levels or may cause your potassium level to become too high. Discuss your intake of potassium-containing foods with your doctor. These foods include: bananas, citrus fruits, watermelon, cantaloupe, raisins, dates, prunes, avocados, apricots, beans, broccoli, brussels sprouts, spinach, potatoes, yams, lentils, fish, chicken, turkey, ham, beef, and low-salt 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 September 2008 Copyright(c) 2008 First DataBank, Inc.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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