Phosphate-Novartis

Potassium Bicarbonate:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Phosphate-Novartis (Potassium Bicarbonate) reviews

Phosphate-Novartis (Potassium Bicarbonate) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

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

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

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

Phosphate-Novartis (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Phosphate-Novartis (Potassium Bicarbonate) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Phosphate-Novartis (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 Phosphate-Novartis (Potassium Bicarbonate) chloride.

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

CLINICAL PHARMACOLOGY

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

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

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

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

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Phosphate-Novartis (Potassium Bicarbonate) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Phosphate-Novartis (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 Phosphate-Novartis (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 Phosphate-Novartis (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 Phosphate-Novartis (Potassium Bicarbonate) salts may be indicated.

CONTRAINDICATIONS

Phosphate-Novartis (Potassium Bicarbonate) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Phosphate-Novartis (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 Phosphate-Novartis (Potassium Bicarbonate) chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Phosphate-Novartis (Potassium Bicarbonate) supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Phosphate-Novartis (Potassium Bicarbonate) Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).

All solid oral dosage forms of Phosphate-Novartis (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.

WARNINGS

Hyperkalemia (see OVERDOSAGE )

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

Interaction with Potassium-Sparing Diuretics

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

Gastrointestinal Lesions

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

PRECAUTIONS

General

The diagnosis of Phosphate-Novartis depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Phosphate-Novartis (Potassium Bicarbonate) depletion. In interpreting the serum Phosphate-Novartis (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 Phosphate-Novartis (Potassium Bicarbonate) while acute acidosis per se can increase the serum Phosphate-Novartis (Potassium Bicarbonate) concentration into the normal range even in the presence of a reduced total body Phosphate-Novartis (Potassium Bicarbonate). The treatment of Phosphate-Novartis (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 Phosphate-Novartis (Potassium Bicarbonate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Phosphate-Novartis (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 Phosphate-Novartis 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. Phosphate-Novartis is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with Phosphate-Novartis (Potassium Bicarbonate) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Phosphate-Novartis (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 Phosphate-Novartis ion content of human milk is about 13 mEq per liter. Since oral Phosphate-Novartis (Potassium Bicarbonate) becomes part of the body Phosphate-Novartis (Potassium Bicarbonate) pool, so long as body Phosphate-Novartis (Potassium Bicarbonate) is not excessive, the contribution of Phosphate-Novartis (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 Phosphate-Novartis (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 Phosphate-Novartis (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 Phosphate-Novartis (Potassium Bicarbonate) salts to persons with normal excretory mechanisms for Phosphate-Novartis (Potassium Bicarbonate) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Phosphate-Novartis (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 Phosphate-Novartis (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 Phosphate-Novartis (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 Phosphate-Novartis (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 Phosphate-Novartis (Potassium Bicarbonate) by the average adult is 50 to 100 mEq per day. Phosphate-Novartis (Potassium Bicarbonate) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Phosphate-Novartis (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 Phosphate-Novartis (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 Phosphate-Novartis (Potassium Bicarbonate) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Phosphate-Novartis (Potassium Bicarbonate) chloride.

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

HOW SUPPLIED

Phosphate-Novartis (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

Phosphate-Novartis (Potassium Bicarbonate) chloride 20 Meq