Potassion

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Potassion uses

Potassion consists of Potassium Bicarbonate, Potassium Bitartrate, Potassium Citrate, Potassium Malate, Potassium Succinate.

Potassium Bicarbonate:



Potassion (Potassium Bicarbonate) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

The Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Potassion (Potassium Bicarbonate) chloride containing 1500 mg of microencapsulated Potassion (Potassium Bicarbonate) chloride, USP equivalent to 20 mEq of Potassion (Potassium Bicarbonate) in a tablet.

These formulations are intended to slow the release of Potassion (Potassium Bicarbonate) so that the likelihood of a high localized concentration of Potassion (Potassium Bicarbonate) chloride within the gastrointestinal tract is reduced.

Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Potassion (Potassium Bicarbonate) chloride, and the structural formula is KCl. Potassion (Potassium Bicarbonate) 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.

Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Potassion (Potassium Bicarbonate) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of Potassion (Potassium Bicarbonate) chloride.

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

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CLINICAL PHARMACOLOGY

The Potassion (Potassium Bicarbonate) ion is the principal intracellular cation of most body tissues. Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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.

Potassion (Potassium Bicarbonate) is a normal dietary constituent and under steady-state conditions the amount of Potassion (Potassium Bicarbonate) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Potassion (Potassium Bicarbonate) is 50 to 100 mEq per day.

Potassion (Potassium Bicarbonate) depletion will occur whenever the rate of Potassion (Potassium Bicarbonate) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Potassion (Potassium Bicarbonate) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of Potassion (Potassium Bicarbonate) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassion (Potassium Bicarbonate) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) in the form of high Potassion (Potassium Bicarbonate) food or Potassion (Potassium Bicarbonate) chloride may be able to restore normal Potassion (Potassium Bicarbonate) levels.

In rare circumstances (eg, patients with renal tubular acidosis) Potassion (Potassium Bicarbonate) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Potassion (Potassium Bicarbonate) replacement should be accomplished with Potassion (Potassium Bicarbonate) salts other than the chloride, such as Potassion (Potassium Bicarbonate) bicarbonate, Potassion (Potassium Bicarbonate) citrate, Potassion (Potassium Bicarbonate) acetate, or Potassion (Potassium Bicarbonate) gluconate.

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INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Potassion (Potassium Bicarbonate) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Potassion (Potassium Bicarbonate) 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, eg, digitalized patients or patients with significant cardiac arrhythmias.

The use of Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) salts may be indicated.

CONTRAINDICATIONS

Potassion (Potassium Bicarbonate) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Potassion (Potassium Bicarbonate) 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 (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

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

All solid oral dosage forms of Potassion (Potassium Bicarbonate) 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.

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WARNINGS

Hyperkalemia (see OVERDOSAGE )

In patients with impaired mechanisms for excreting Potassion (Potassium Bicarbonate), the administration of Potassion (Potassium Bicarbonate) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Potassion (Potassium Bicarbonate) by the intravenous route but may also occur in patients given Potassion (Potassium Bicarbonate) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Potassion (Potassium Bicarbonate) salts in patients with chronic renal disease, or any other condition which impairs Potassion (Potassium Bicarbonate) excretion, requires particularly careful monitoring of the serum Potassion (Potassium Bicarbonate) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) retention by inhibiting aldosterone production. Potassion (Potassium Bicarbonate) supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of Potassion (Potassium Bicarbonate) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Potassion (Potassium Bicarbonate) 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. Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Potassion (Potassium Bicarbonate) chloride and thus to minimize the possibility of a high local concentration of Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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. Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq 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 Potassion (Potassium Bicarbonate) salt such as Potassion (Potassium Bicarbonate) bicarbonate, Potassion (Potassium Bicarbonate) citrate, Potassion (Potassium Bicarbonate) acetate, or Potassion (Potassium Bicarbonate) gluconate.

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PRECAUTIONS

General

The diagnosis of Potassion depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Potassion (Potassium Bicarbonate) depletion. In interpreting the serum Potassion (Potassium Bicarbonate) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body Potassion (Potassium Bicarbonate) while acute acidosis per se can increase the serum Potassion (Potassium Bicarbonate) concentration into the normal range even in the presence of a reduced total body Potassion (Potassium Bicarbonate). The treatment of Potassion (Potassium Bicarbonate) 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.

Information for Patients

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:

  • Break the tablet in half, and take each half separately with a glass of water.
  • 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 Potassion (Potassium Bicarbonate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq 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.

Laboratory Tests

When blood is drawn for analysis of plasma Potassion 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.

Drug Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Potassion is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Potassion (Potassium Bicarbonate) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal Potassion ion content of human milk is about 13 mEq per liter. Since oral Potassion (Potassium Bicarbonate) becomes part of the body Potassion (Potassium Bicarbonate) pool, so long as body Potassion (Potassium Bicarbonate) is not excessive, the contribution of Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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.

ADVERSE REACTIONS

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 Potassion (Potassium Bicarbonate) 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.

OVERDOSAGE

The administration of oral Potassion (Potassium Bicarbonate) salts to persons with normal excretory mechanisms for Potassion (Potassium Bicarbonate) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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 arrhythmias and electrolyte changes.
  • Elimination of foods and medications containing Potassion (Potassium Bicarbonate) and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
  • Intravenous calcium gluconate if the patient is at no risk of developing digitalis toxicity.
  • Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
  • Correction of acidosis, if present, with intravenous sodium bicarbonate.
  • 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 Potassion (Potassium Bicarbonate) 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.

DOSAGE AND ADMINISTRATION

The usual dietary intake of Potassion (Potassium Bicarbonate) by the average adult is 50 to 100 mEq per day. Potassion (Potassium Bicarbonate) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) 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 Potassion (Potassium Bicarbonate) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Potassion (Potassium Bicarbonate) chloride.

Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq 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 1/2 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 1 fluid ounce of water, swirl, and consume immediately.
    • Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of Potassion (Potassium Bicarbonate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

HOW SUPPLIED

Potassion (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.

Storage Conditions

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by:

Eurand, Inc.

Vandalia, OH 45377 USA

Distributed by:

Watson Pharma, Inc.

Rev. Date (01/09) 173714

Potassion (Potassium Bicarbonate) chloride 20 Meq

Potassium Bitartrate:



Potassion (Potassium Bitartrate) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

The Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Potassion (Potassium Bitartrate) chloride containing 1500 mg of microencapsulated Potassion (Potassium Bitartrate) chloride, USP equivalent to 20 mEq of Potassion (Potassium Bitartrate) in a tablet.

These formulations are intended to slow the release of Potassion (Potassium Bitartrate) so that the likelihood of a high localized concentration of Potassion (Potassium Bitartrate) chloride within the gastrointestinal tract is reduced.

Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Potassion (Potassium Bitartrate) chloride, and the structural formula is KCl. Potassion (Potassium Bitartrate) 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.

Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Potassion (Potassium Bitartrate) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of Potassion (Potassium Bitartrate) chloride.

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

CLINICAL PHARMACOLOGY

The Potassion (Potassium Bitartrate) ion is the principal intracellular cation of most body tissues. Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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.

Potassion (Potassium Bitartrate) is a normal dietary constituent and under steady-state conditions the amount of Potassion (Potassium Bitartrate) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Potassion (Potassium Bitartrate) is 50 to 100 mEq per day.

Potassion (Potassium Bitartrate) depletion will occur whenever the rate of Potassion (Potassium Bitartrate) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Potassion (Potassium Bitartrate) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of Potassion (Potassium Bitartrate) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassion (Potassium Bitartrate) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) in the form of high Potassion (Potassium Bitartrate) food or Potassion (Potassium Bitartrate) chloride may be able to restore normal Potassion (Potassium Bitartrate) levels.

In rare circumstances (eg, patients with renal tubular acidosis) Potassion (Potassium Bitartrate) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Potassion (Potassium Bitartrate) replacement should be accomplished with Potassion (Potassium Bitartrate) salts other than the chloride, such as Potassion (Potassium Bitartrate) bicarbonate, Potassion (Potassium Bitartrate) citrate, Potassion (Potassium Bitartrate) acetate, or Potassion (Potassium Bitartrate) gluconate.

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Potassion (Potassium Bitartrate) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Potassion (Potassium Bitartrate) 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, eg, digitalized patients or patients with significant cardiac arrhythmias.

The use of Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) salts may be indicated.

CONTRAINDICATIONS

Potassion (Potassium Bitartrate) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Potassion (Potassium Bitartrate) 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 (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

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

All solid oral dosage forms of Potassion (Potassium Bitartrate) 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.

WARNINGS

Hyperkalemia (see OVERDOSAGE )

In patients with impaired mechanisms for excreting Potassion (Potassium Bitartrate), the administration of Potassion (Potassium Bitartrate) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Potassion (Potassium Bitartrate) by the intravenous route but may also occur in patients given Potassion (Potassium Bitartrate) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Potassion (Potassium Bitartrate) salts in patients with chronic renal disease, or any other condition which impairs Potassion (Potassium Bitartrate) excretion, requires particularly careful monitoring of the serum Potassion (Potassium Bitartrate) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) retention by inhibiting aldosterone production. Potassion (Potassium Bitartrate) supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of Potassion (Potassium Bitartrate) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Potassion (Potassium Bitartrate) 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. Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Potassion (Potassium Bitartrate) chloride and thus to minimize the possibility of a high local concentration of Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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. Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq 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 Potassion (Potassium Bitartrate) salt such as Potassion (Potassium Bitartrate) bicarbonate, Potassion (Potassium Bitartrate) citrate, Potassion (Potassium Bitartrate) acetate, or Potassion (Potassium Bitartrate) gluconate.

PRECAUTIONS

General

The diagnosis of Potassion depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Potassion (Potassium Bitartrate) depletion. In interpreting the serum Potassion (Potassium Bitartrate) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body Potassion (Potassium Bitartrate) while acute acidosis per se can increase the serum Potassion (Potassium Bitartrate) concentration into the normal range even in the presence of a reduced total body Potassion (Potassium Bitartrate). The treatment of Potassion (Potassium Bitartrate) 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.

Information for Patients

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:

  • Break the tablet in half, and take each half separately with a glass of water.
  • 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 Potassion (Potassium Bitartrate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq 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.

Laboratory Tests

When blood is drawn for analysis of plasma Potassion 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.

Drug Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Potassion is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Potassion (Potassium Bitartrate) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal Potassion ion content of human milk is about 13 mEq per liter. Since oral Potassion (Potassium Bitartrate) becomes part of the body Potassion (Potassium Bitartrate) pool, so long as body Potassion (Potassium Bitartrate) is not excessive, the contribution of Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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.

ADVERSE REACTIONS

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 Potassion (Potassium Bitartrate) 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.

OVERDOSAGE

The administration of oral Potassion (Potassium Bitartrate) salts to persons with normal excretory mechanisms for Potassion (Potassium Bitartrate) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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 arrhythmias and electrolyte changes.
  • Elimination of foods and medications containing Potassion (Potassium Bitartrate) and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
  • Intravenous calcium gluconate if the patient is at no risk of developing digitalis toxicity.
  • Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
  • Correction of acidosis, if present, with intravenous sodium bicarbonate.
  • 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 Potassion (Potassium Bitartrate) 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.

DOSAGE AND ADMINISTRATION

The usual dietary intake of Potassion (Potassium Bitartrate) by the average adult is 50 to 100 mEq per day. Potassion (Potassium Bitartrate) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) 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 Potassion (Potassium Bitartrate) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Potassion (Potassium Bitartrate) chloride.

Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq 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 1/2 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 1 fluid ounce of water, swirl, and consume immediately.
    • Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of Potassion (Potassium Bitartrate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

HOW SUPPLIED

Potassion (Potassium Bitartrate) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.

Storage Conditions

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by:

Eurand, Inc.

Vandalia, OH 45377 USA

Distributed by:

Watson Pharma, Inc.

Rev. Date (01/09) 173714

Potassion (Potassium Bitartrate) chloride 20 Meq

Potassium Citrate:



Potassion (Potassium Citrate) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

The Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Potassion (Potassium Citrate) chloride containing 1500 mg of microencapsulated Potassion (Potassium Citrate) chloride, USP equivalent to 20 mEq of Potassion (Potassium Citrate) in a tablet.

These formulations are intended to slow the release of Potassion (Potassium Citrate) so that the likelihood of a high localized concentration of Potassion (Potassium Citrate) chloride within the gastrointestinal tract is reduced.

Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Potassion (Potassium Citrate) chloride, and the structural formula is KCl. Potassion (Potassium Citrate) 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.

Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Potassion (Potassium Citrate) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of Potassion (Potassium Citrate) chloride.

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

CLINICAL PHARMACOLOGY

The Potassion (Potassium Citrate) ion is the principal intracellular cation of most body tissues. Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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.

Potassion (Potassium Citrate) is a normal dietary constituent and under steady-state conditions the amount of Potassion (Potassium Citrate) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Potassion (Potassium Citrate) is 50 to 100 mEq per day.

Potassion (Potassium Citrate) depletion will occur whenever the rate of Potassion (Potassium Citrate) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Potassion (Potassium Citrate) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of Potassion (Potassium Citrate) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassion (Potassium Citrate) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) in the form of high Potassion (Potassium Citrate) food or Potassion (Potassium Citrate) chloride may be able to restore normal Potassion (Potassium Citrate) levels.

In rare circumstances (eg, patients with renal tubular acidosis) Potassion (Potassium Citrate) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Potassion (Potassium Citrate) replacement should be accomplished with Potassion (Potassium Citrate) salts other than the chloride, such as Potassion (Potassium Citrate) bicarbonate, Potassion (Potassium Citrate) citrate, Potassion (Potassium Citrate) acetate, or Potassion (Potassium Citrate) gluconate.

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Potassion (Potassium Citrate) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Potassion (Potassium Citrate) 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, eg, digitalized patients or patients with significant cardiac arrhythmias.

The use of Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) salts may be indicated.

CONTRAINDICATIONS

Potassion (Potassium Citrate) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Potassion (Potassium Citrate) 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 (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

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

All solid oral dosage forms of Potassion (Potassium Citrate) 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.

WARNINGS

Hyperkalemia (see OVERDOSAGE )

In patients with impaired mechanisms for excreting Potassion (Potassium Citrate), the administration of Potassion (Potassium Citrate) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Potassion (Potassium Citrate) by the intravenous route but may also occur in patients given Potassion (Potassium Citrate) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Potassion (Potassium Citrate) salts in patients with chronic renal disease, or any other condition which impairs Potassion (Potassium Citrate) excretion, requires particularly careful monitoring of the serum Potassion (Potassium Citrate) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) retention by inhibiting aldosterone production. Potassion (Potassium Citrate) supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of Potassion (Potassium Citrate) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Potassion (Potassium Citrate) 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. Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Potassion (Potassium Citrate) chloride and thus to minimize the possibility of a high local concentration of Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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. Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq 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 Potassion (Potassium Citrate) salt such as Potassion (Potassium Citrate) bicarbonate, Potassion (Potassium Citrate) citrate, Potassion (Potassium Citrate) acetate, or Potassion (Potassium Citrate) gluconate.

PRECAUTIONS

General

The diagnosis of Potassion depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Potassion (Potassium Citrate) depletion. In interpreting the serum Potassion (Potassium Citrate) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body Potassion (Potassium Citrate) while acute acidosis per se can increase the serum Potassion (Potassium Citrate) concentration into the normal range even in the presence of a reduced total body Potassion (Potassium Citrate). The treatment of Potassion (Potassium Citrate) 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.

Information for Patients

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:

  • Break the tablet in half, and take each half separately with a glass of water.
  • 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 Potassion (Potassium Citrate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq 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.

Laboratory Tests

When blood is drawn for analysis of plasma Potassion 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.

Drug Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Potassion is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Potassion (Potassium Citrate) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal Potassion ion content of human milk is about 13 mEq per liter. Since oral Potassion (Potassium Citrate) becomes part of the body Potassion (Potassium Citrate) pool, so long as body Potassion (Potassium Citrate) is not excessive, the contribution of Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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.

ADVERSE REACTIONS

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 Potassion (Potassium Citrate) 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.

OVERDOSAGE

The administration of oral Potassion (Potassium Citrate) salts to persons with normal excretory mechanisms for Potassion (Potassium Citrate) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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 arrhythmias and electrolyte changes.
  • Elimination of foods and medications containing Potassion (Potassium Citrate) and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
  • Intravenous calcium gluconate if the patient is at no risk of developing digitalis toxicity.
  • Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
  • Correction of acidosis, if present, with intravenous sodium bicarbonate.
  • 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 Potassion (Potassium Citrate) 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.

DOSAGE AND ADMINISTRATION

The usual dietary intake of Potassion (Potassium Citrate) by the average adult is 50 to 100 mEq per day. Potassion (Potassium Citrate) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) 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 Potassion (Potassium Citrate) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Potassion (Potassium Citrate) chloride.

Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq 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 1/2 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 1 fluid ounce of water, swirl, and consume immediately.
    • Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of Potassion (Potassium Citrate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

HOW SUPPLIED

Potassion (Potassium Citrate) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.

Storage Conditions

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by:

Eurand, Inc.

Vandalia, OH 45377 USA

Distributed by:

Watson Pharma, Inc.

Rev. Date (01/09) 173714

Potassion (Potassium Citrate) chloride 20 Meq

Potassium Succinate:



Potassion (Potassium Succinate) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

The Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Potassion (Potassium Succinate) chloride containing 1500 mg of microencapsulated Potassion (Potassium Succinate) chloride, USP equivalent to 20 mEq of Potassion (Potassium Succinate) in a tablet.

These formulations are intended to slow the release of Potassion (Potassium Succinate) so that the likelihood of a high localized concentration of Potassion (Potassium Succinate) chloride within the gastrointestinal tract is reduced.

Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Potassion (Potassium Succinate) chloride, and the structural formula is KCl. Potassion (Potassium Succinate) 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.

Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Potassion (Potassium Succinate) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of Potassion (Potassium Succinate) chloride.

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

CLINICAL PHARMACOLOGY

The Potassion (Potassium Succinate) ion is the principal intracellular cation of most body tissues. Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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.

Potassion (Potassium Succinate) is a normal dietary constituent and under steady-state conditions the amount of Potassion (Potassium Succinate) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Potassion (Potassium Succinate) is 50 to 100 mEq per day.

Potassion (Potassium Succinate) depletion will occur whenever the rate of Potassion (Potassium Succinate) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Potassion (Potassium Succinate) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of Potassion (Potassium Succinate) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassion (Potassium Succinate) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) in the form of high Potassion (Potassium Succinate) food or Potassion (Potassium Succinate) chloride may be able to restore normal Potassion (Potassium Succinate) levels.

In rare circumstances (eg, patients with renal tubular acidosis) Potassion (Potassium Succinate) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Potassion (Potassium Succinate) replacement should be accomplished with Potassion (Potassium Succinate) salts other than the chloride, such as Potassion (Potassium Succinate) bicarbonate, Potassion (Potassium Succinate) citrate, Potassion (Potassium Succinate) acetate, or Potassion (Potassium Succinate) gluconate.

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Potassion (Potassium Succinate) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Potassion (Potassium Succinate) 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, eg, digitalized patients or patients with significant cardiac arrhythmias.

The use of Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) salts may be indicated.

CONTRAINDICATIONS

Potassion (Potassium Succinate) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Potassion (Potassium Succinate) 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 (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

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

All solid oral dosage forms of Potassion (Potassium Succinate) 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.

WARNINGS

Hyperkalemia (see OVERDOSAGE )

In patients with impaired mechanisms for excreting Potassion (Potassium Succinate), the administration of Potassion (Potassium Succinate) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Potassion (Potassium Succinate) by the intravenous route but may also occur in patients given Potassion (Potassium Succinate) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Potassion (Potassium Succinate) salts in patients with chronic renal disease, or any other condition which impairs Potassion (Potassium Succinate) excretion, requires particularly careful monitoring of the serum Potassion (Potassium Succinate) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) retention by inhibiting aldosterone production. Potassion (Potassium Succinate) supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of Potassion (Potassium Succinate) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Potassion (Potassium Succinate) 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. Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Potassion (Potassium Succinate) chloride and thus to minimize the possibility of a high local concentration of Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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. Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq 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 Potassion (Potassium Succinate) salt such as Potassion (Potassium Succinate) bicarbonate, Potassion (Potassium Succinate) citrate, Potassion (Potassium Succinate) acetate, or Potassion (Potassium Succinate) gluconate.

PRECAUTIONS

General

The diagnosis of Potassion depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Potassion (Potassium Succinate) depletion. In interpreting the serum Potassion (Potassium Succinate) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body Potassion (Potassium Succinate) while acute acidosis per se can increase the serum Potassion (Potassium Succinate) concentration into the normal range even in the presence of a reduced total body Potassion (Potassium Succinate). The treatment of Potassion (Potassium Succinate) 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.

Information for Patients

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:

  • Break the tablet in half, and take each half separately with a glass of water.
  • 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 Potassion (Potassium Succinate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq 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.

Laboratory Tests

When blood is drawn for analysis of plasma Potassion 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.

Drug Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Potassion is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Potassion (Potassium Succinate) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal Potassion ion content of human milk is about 13 mEq per liter. Since oral Potassion (Potassium Succinate) becomes part of the body Potassion (Potassium Succinate) pool, so long as body Potassion (Potassium Succinate) is not excessive, the contribution of Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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.

ADVERSE REACTIONS

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 Potassion (Potassium Succinate) 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.

OVERDOSAGE

The administration of oral Potassion (Potassium Succinate) salts to persons with normal excretory mechanisms for Potassion (Potassium Succinate) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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 arrhythmias and electrolyte changes.
  • Elimination of foods and medications containing Potassion (Potassium Succinate) and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
  • Intravenous calcium gluconate if the patient is at no risk of developing digitalis toxicity.
  • Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
  • Correction of acidosis, if present, with intravenous sodium bicarbonate.
  • 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 Potassion (Potassium Succinate) 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.

DOSAGE AND ADMINISTRATION

The usual dietary intake of Potassion (Potassium Succinate) by the average adult is 50 to 100 mEq per day. Potassion (Potassium Succinate) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) 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 Potassion (Potassium Succinate) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Potassion (Potassium Succinate) chloride.

Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq 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 1/2 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 1 fluid ounce of water, swirl, and consume immediately.
    • Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of Potassion (Potassium Succinate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

HOW SUPPLIED

Potassion (Potassium Succinate) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.

Storage Conditions

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by:

Eurand, Inc.

Vandalia, OH 45377 USA

Distributed by:

Watson Pharma, Inc.

Rev. Date (01/09) 173714

Potassion (Potassium Succinate) chloride 20 Meq

Potassion pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Potassion available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Potassion destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Potassion Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Potassion pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."KLOR-CON/EF (POTASSIUM BICARBONATE) TABLET, EFFERVESCENT [SANDOZ INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."POTASSIUM CITRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Potassion?

Depending on the reaction of the Potassion after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Potassion not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Potassion addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Potassion, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Potassion consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

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One visitor reported doses

What is the dose of Potassion drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg1
100.0%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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