Klor-con M10
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Questions & Answers
Side Effects & Adverse Reactions
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 patients years) compared to extended-release wax matrix formulations (less than one per 100,000 patients 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® M is a tablet formulated to provide an extended rate of release of microencapsulated potassium chloride and thus to minimize the possibility of a high 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 wax matrix extended-release formulation under conditions 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® M 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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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.
- 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.
History
There is currently no drug history available for this drug.
Other Information
Klor-Con® M20 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.
Klor-Con® M15 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet.
Klor-Con® M10 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.
Klor-Con® M is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCI (molecular weight: 74.55). 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.
Klor-Con® M 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 37ºC and in the absence of outside agitation, Klor-Con® M begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride.
Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose.
Sources
Klor-con M10 Manufacturers
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Apace Packaging Llc
![Klor-con M10 (Potassium Chloride) Tablet, Extended Release Klor-con M20 (Potassium Chloride) Tablet, Extended Release [Apace Packaging Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Klor-con M10 | Apace Packaging Llc
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.
Klor-Con® M20 Tablet provided 1500 mg of potassium chloride equivalent to 20 mEq of potassium.
Klor-Con® M10 Tablet provided 750 mg of potassium chloride equivalent to 10 mEq of potassium.
Klor-Con® M 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 alternative methods of administration:
a. Break the tablet in half and take each half separately with a glass of water.
b. Prepare an aqueous (water) suspension as follows:
Place the whole tablet(s) in approximately one-half glass of water (4 fluid ounces). Allow approximately 2 minutes for the tablet(s) to disintegrate. Stir for about half a minute after the tablet(s) had disintegrated. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw. Add another one fluid ounce of water, swirl and consume immediately. Then, add an additional one fluid ounce of water, swirl and consume immediatelyAqueous suspension of Klor-Con® M Extended-release Tablet that is not taken immediately should be discarded. The use of other liquids for suspending Klor-Con® M is not recommended.
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Cardinal Health
Klor-con M10 | Cardinal Health
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 Klor-Con® M20 tablet provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium.
Each Klor-Con® M15 tablet provides 1125 mg of potassium chloride equivalent to 15 mEq of potassium.
Each Klor-Con® M10 tablet provides 750 mg of potassium chloride equivalent to 10 mEq of potassium.
Klor-Con® M 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:
Break the tablet in half and take each half separately with a glass of water. Prepare an aqueous (water) suspension as follows: Place the whole tablet(s) in approximately one-half glass of water (4 fluid ounces). Allow approximately 2 minutes for the tablet(s) to disintegrate. Stir for about half a minute after the tablet(s) has disintegrated. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw. Add another one fluid ounce of water, swirl, and consume immediately. Then, add an additional one fluid ounce of water, swirl, and consume immediately. Aqueous suspension of Klor-Con ® M extended-release tablet that is not taken immediately should be discarded. The use of other liquids for suspending Klor-Con ® M tablets is not recommended.
![Klor-con M10 (Potassium Chloride) Tablet, Extended Release Klor-con M20 (Potassium Chloride) Tablet, Extended Release [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=86bc05c8-49f7-495b-8144-88ad03c5983f&name=1c639b6b-a6b1-4cc8-a2b2-29af89dedaa3-01.jpg)
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