Potassium Chloride Extended-Release Capsules, USP, Novel Laboratories, Inc., Rx Only

/Potassium Chloride Extended-Release Capsules, USP, Novel Laboratories, Inc., Rx Only
Potassium Chloride Extended-Release Capsules, USP, Novel Laboratories, Inc., Rx Only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Potassium Chloride Extended-Release Capsules, USP, Novel Laboratories, Inc., Rx Only

ID:

7727e564-3680-4c51-897b-b35b74a33db2

Code:

34391-3

DESCRIPTION


id: a6b18116-03a8-490b-859a-70a4c1b372dc
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Potassium Chloride Extended-release Capsules USP, 8 mEq and 10 mEq are oral dosage forms of microencapsulated potassium chloride containing 600 and 750 mg, respectively, of potassium chloride USP equivalent to 8 and 10 mEq of potassium. Availability of potassium chloride (KCl) in extended-release manner is accomplished by microencapsulation of potassium chloride and a dispersing agent. The resultant flow characteristics of the KCI microcapsules and the controlled release of K+ ions by the microcapsular membrane are intended to avoid the possibility that excessive amounts of KCI can be localized at any point on the mucosa of the gastrointestinal tract. Each crystal of KCI is microencapsulated by a process with an insoluble polymeric coating which functions as a semi-permeable membrane; it allows for the controlled release of potassium and chloride ions over an eight-to-ten-hour period. Fluids pass through the membrane and gradually dissolve the potassium chloride within the micro-capsules. The resulting potassium chloride solution slowly diffuses outward through the membrane. Potassium Chloride Extended-release Capsules, USP, 8 mEq and 10 mEq are electrolyte replenishers. The chemical name of the active ingredient is potassium chloride and the structural formula is KCI. Potassium chloride USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are ethylcellulose, triethyl citrate, sodium lauryl sulfate, FD&C blue #1, FD&C red # 40, gelatin, titanium dioxide, shellac, potassium hydroxide and black iron oxide.

CLINICAL PHARMACOLOGY


id: a85584e8-cd4b-4e4e-81c8-b914b19eabb9
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal, and smooth muscle, and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops slowly as a consequence of therapy with diuretics, primary or secondary hyperaldosteronisms, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine. If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long-term diuretic therapy, supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels. In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

INDICATIONS AND USAGE


id: af8c7d6f-bd05-475a-8fc0-8902d377bcbb
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal states.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

CONTRAINDICATIONS


id: a39fc27b-e3b7-4552-9c6b-245494493247
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium 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 (e.g., spironolactone, triamterene, amiloride) (see OVERDOSAGE). Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation. All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis) or pharmacologic (use of anticholinergic agents or other agents with anticholineric properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in capsule passage through the gastrointestinal tract.

WARNINGS


id: a69969f1-4de2-46f3-98e0-1f96a6ed43af
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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

PRECAUTIONS


id: a2bdf02e-2ca4-41cc-bd4a-903db58713c7
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

General The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium, while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

ADVERSE REACTIONS


id: a6826f50-7e9e-40f0-92f8-3785c6a64f30
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, AND OVERDOSAGE). Gastrointestinal bleeding and ulceration have been reported in patients treated with Potassium Chloride Extended- release Capsules, USP, 8 mEq and 10 mEq (see CONTRAINDICATIONS and WARNINGS). In addition to gastrointestinal bleeding and ulceration, perforation and obstruction have been reported in patients treated with other solid KCI dosage forms, and may occur with Potassium Chloride Extended-release Capsules, USP, 8 mEq and 10 mEq. The most common adverse reactions to the oral potassium salts are nausea, vomiting, flatulence, abdominal discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by taking the dose with meals, or reducing the amount taken at one time. Skin rash has been reported rarely with potassium preparations.

OVERDOSAGE


id: aee4924e-69f5-43b7-9975-d8560d680aa7
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium 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 potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of ST 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: (1) elimination of foods and medications containing potassium and of any agents with potassium-sparing properties; (2) intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL; (3) correction of acidosis, if present, with intravenous sodium bicarbonate; (4) 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 potassium 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


id: a7254254-06de-47f6-b63c-c760abf61967
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store Dosage must be adjusted to the individual needs of each patients. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose. Because of the potential for gastric irritation (see WARNINGS), Potassium Chloride Extended-release Capsules, USP, 8 mEq and 10 mEq should be taken with meals and with a full glass of water or other liquid. Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of cool water or juice to ensure complete swallowing of the microcapsules. The food used should not be hot and should be soft enough to be swallowed without chewing. Any microcapsule/food mixture should be used immediately and not stored for future use.

HOW SUPPLIED


id: a9c873f3-32f1-43f9-8888-35c381c1ac5f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Potassium Chloride Extended-Release Capsules USP, 8 mEq are hard gelatin capsules with white opaque cap and white opaque body, imprinted “NL 910” on the cap and “600 mg” on the body in black ink, filled with white to off white crystals. Bottles of 100 (NDC 40032-910-01) Bottles of 500 (NDC 40032-910-05) Potassium Chloride Extended-Release Capsules USP, 10 mEq are hard gelatin capsules with dark blue opaque cap and dark blue opaque body, imprinted “NL 911” on the cap and “750 mg” on the body in white ink, filled with white to off white crystals. Bottles of 90 (NDC 40032-911-09) Bottles of 500 (NDC 40032-911-05) Store at 20°- 25°C (68° – 77°F). [See USP Controlled Room Temperature] Dispense in tight container. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 USA PI9110000101 Rev. 07/2015

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: ad5d0b35-6dd6-4a76-ac4b-afc4a80679a5
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Potassium Chloride Extended-Release Capsules USP, 8 mEq 100 Extended-Release Capsules NDC 40032-910-01 Potassium Chloride Extended-Release Capsules USP, 10 mEq 90 Extended-Release Capsules NDC 40032-911-09