Sensoform-HK

Potassium Nitrate:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Sensoform-HK (Potassium Nitrate) reviews

Sensoform-HK (Potassium Nitrate) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

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

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

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

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

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

CLINICAL PHARMACOLOGY

The Sensoform-HK (Potassium Nitrate) ion is the principal intracellular cation of most body tissues. Sensoform-HK (Potassium Nitrate) 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 Sensoform-HK (Potassium Nitrate) 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.

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

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

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

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

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

All solid oral dosage forms of Sensoform-HK (Potassium Nitrate) 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 Sensoform-HK (Potassium Nitrate), the administration of Sensoform-HK (Potassium Nitrate) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Sensoform-HK (Potassium Nitrate) by the intravenous route but may also occur in patients given Sensoform-HK (Potassium Nitrate) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Sensoform-HK (Potassium Nitrate) salts in patients with chronic renal disease, or any other condition which impairs Sensoform-HK (Potassium Nitrate) excretion, requires particularly careful monitoring of the serum Sensoform-HK (Potassium Nitrate) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

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

Gastrointestinal Lesions

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

PRECAUTIONS

General

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

Pregnancy Category C

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

Nursing Mothers

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

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

HOW SUPPLIED

Sensoform-HK (Potassium Nitrate) 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

Sensoform-HK (Potassium Nitrate) chloride 20 Meq