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Potassium Chloride
Extended-Release Capsules and Tablets Potassium chloride extended-release capsules, USP are a solid oral dosage form of potasium chloride containing 10 mEq (750 mg) of potassium chloride [equivalent to 10 mEq (390 mg) of potassium and 10 mEq (360 mg) of chloride] in a microencapsulated capsule. This formulation is intended to 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 capsules are an electrolyte replenisher. The chemical name 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. Inactive ingredients: Calcium stearate, gelatin, pharmaceutical glaze, povidone, sugar spheres, talc. Klor-Con Extended-release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 or 750 mg of potassium chloride equivalent to 8mEq or 10mEq of potassium in a wax matrix tablet. Extended-Release Formulation for Liquid Suspension Potassium chloride liquid suspension is an oral dosage form of microencapsulated potassium chloride. Each packet contains 1.5 g of potassium chloride, USP equivalent to 20 mEq of potassium. Potassium chloride liquid suspension is comprised of specially formulated granules. After reconstituting with 2-6 fly o of water and 1 minute of stirring, the suspension is odorless and tasteless. Each crystal of potassium chloride (KCl) is microencapsulated with an insoluble polymeric coating which functions as a semipermeable membrane; it allows for the controlled release of potassium and chloride ions over an eight-ten hour period. The controlled release of K+ ions by the microcapsular membrane is intended to reduce the likelihood of a high localized concentration of potassium chloride at any point on the mucosa of the gastrointestinal tract. Fluids pass through the membrane and gradually dissolve the potassium chloride within the microcapsules. The resulting potassium chloride solution slowly diffuses outward through the membrane. Potassium chloride liquid suspension 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. Inactive Ingredients: Docusate Sodium, Ethylcellulose,
Povidone, Silicon Dioxide, Sucrose, and another ingredient.
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 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.
EXTENDED-RELEASE CAPSULES AND TABLETS: 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 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 therapy, 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 levels 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. EXTENDED-RELEASE FORMULATION FOR LIQUID SUSPENSION: 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 IMMEDIATE RELEASE LIQUIDS/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, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium losing nephropathy, and certain diarrheal states). 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 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. Extended-Release Capsules and Tablets K-Norm Capsules provide 10 mEq of potassium chloride. K-Norm Capsules 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). Those patients having difficulty swallowing the capsules may be advised to sprinkle the contents onto a spoonful of soft food to facilitate ingestion. Each Klor-Con Extended-Release Tablet provides 8mEq or 10mEq of potassium chloride. Klor-Con Extended-release Tablets should be taken with meals and with a glass of water or other liquid. Extended-Release Formulation for Liquid Suspension Usual Adult Dose: One potassium chloride liquid suspension 20 mEq packet 1 to 5 times daily, depending on the requirements of the patient. This product must be suspended in a liquid, preferably water, or sprinkled on food prior to ingestion. Suspension in Water: Pour contents of packet slowly into approximately 2-6 fluid ounces (1/4 - 3/4 glassful) of water. Stir thoroughly for approximately 1 minute until slightly thickened, then drink. The entire contents of the packet must be used immediately and not stored for future use. Any microcapsule/water mixture should be used immediately and not stored for future use. Suspension in Liquids other than Water: Studies conducted using orange juice, tomato juice, apple juice and milk as the suspending liquid have shown that the quantity of fluid used to suspend one potassium chloride liquid suspension packet MUST be limited to 2 fluid ounces (1/4 glassful). The use of volumes greater than 2 fluid ounces substantially reduces the dose of potassium chloride delivered. If a liquid other than water is used to suspend potassium chloride liquid suspension then the contents of the packet should be slowly poured into 2 fluid ounces (1/4 glassful) of liquid. Stir thoroughly for approximately 1 minute, then drink. The entire contents of the packet must be used immediately and not stored for future use. Any microcapsule/liquid mixture should be used immediately and not stored for future use. Sprinkling Contents on Food: Potassium chloride liquid suspension may be given on soft food that may be swallowed easily without chewing, such as applesauce or pudding. After sprinkling the contents of the packet on the food, it should be swallowed immediately without chewing and followed with a glass of cool water, milk, or juice to ensure complete swallowing of all the microcapsules. Do not store microcapsule/food mixture for future use. HOW SUPPLIED Extended-Release Capsules and Tablets: K-Norm Capsules are clear/clear hard gelatin capsules, containing 10 mEq (750 mg) of potassium chloride [equivalent to 10 mEq (390 mg) of potassium and 10 mEq (360 mg) of chloride]. Each capsule is imprinted with "K-Norm" on one side and "10" on the other side. Film coated Klor-Con 8 (blue), imprinted round tablets containing: 600 mg potassium chloride (equivalent to 8 mEq). Film coated Klor-Con 10 (yellow), imprinted round tablets containing: 750 mg potassium chloride (equivalent to 10 mEq). Mico-K 8 Extencaps are pale orange capsules monogrammed Mick-K and AHR/5720, each containing 600 mg potassium chloride (equivalent to 8 mEq). Mico-K 10 Extencaps are pale orange and opaque white capsules monogrammed Mick-K and AHR/5730, each containing 750 mg potassium chloride (equivalent to 10 mEq). Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in container with child-resistant closure. Extended-Release Formulation for Liquid Suspension: Micro-K LS containing 1.5 g microencapsulated potassium chloride (equivalent to 20 mEq K) per packet in cartons of 30 and 100 packets. Store at controlled room temperature, between 15°C and 30°C (59°F and 86°F).
One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE). The most common adverse reactions to the oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Skin rash has been reported rarely. Extended-Release Capsules and Tablets: There also have been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS). 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. Extended-Release Formulation for Liquid Suspension: Gastrointestinal bleeding and ulceration have been reported in patients treated with microencapsulated KCl (see WARNINGS). In addition to bleeding and ulceration, perforation and obstruction have been reported in patients treated with solid KCl dosage forms, and may occur with potassium chloride liquid suspension. 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. In a controlled clinical study, potassium chloride liquid suspension was associated with an increased frequency of gastrointestinal intolerance (e.g., diarrhea, loose stools, abdominal pain, etc.) compared to equal doses (100 mEq/day) of Micro-K Extencaps (see WARNINGS, Diarrhea or Dehydration). This finding was attributed to an inactive ingredient used in the Micro- K LS formulation that is not present in the Micro-K Extencaps formulation.
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 and deaths. 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 and 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. Extended-Release Capsules and Tablets: Potassium chloride capsules and tablets are microencapsulated capsules formulated to provide a controlled rate of release of potassium chloride and thus to minimize the possibility of a high local concentration of potassium near the gastrointestinal wall. Extended-Release Formulation for Liquid Suspension: Potassium chloride liquid suspension is administered as a liquid suspension of microencapsulated potassium chloride formulated to provide a controlled rate of release of potassium chloride and thus to minimize the possibility of a high local concentration of potassium near the gastrointestinal wall. Diarrhea or Dehydration: Potassium chloride liquid suspension contains, as a dispersing agent, docusate sodium, which also increases stool water and is used as a stool softener. Clinical studies with Potassium chloride liquid suspension indicate that minor changes in stool consistency may be common, although usually are well- tolerated. However, rarely patients may experience diarrhea or cramping abdominal pain. Patients with severe or chronic diarrhea or who are dehydrated ordinarily should not be prescribed potassium chloride liquid suspension. Extended-Release Capsules and Tablets and Extended-Release Formulation for Liquid Suspension: 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 and controlled 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 and controlled 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. Potassium chloride extended- release capsules, USP and potassium chloride liquid suspension 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 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. Extended-Release Capsules and Tablets: Regular serum potassium determinations are recommended. Potassium should generally not be given in the immediate postoperative period until urine wflow is established. Information for the Patient Physicians should consider reminding the patient of the following:
Extended-Release Capsules and Tablets
Extended-Release Formulation for Liquid Suspension
Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent. Laboratory Tests Extended-Release Capsules and Tablets: 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. Pregnancy, Teratogenic Effects, Pregnancy Category C Animal reproduction studies have not been conducted with potassium chloride capsules and tablets and potassium chloride liquid suspension. 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 party 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/children have not been established. Extended-Release Formulation for Liquid Suspension: Regular serum potassium determinations are recommended, especially in patients with renal insufficiency or diabetic nephropathy. 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.
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