Potassium Chloride Extended-release Capsules, USP

/Potassium Chloride Extended-release Capsules, USP
Potassium Chloride Extended-release Capsules, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Potassium Chloride Extended-release Capsules, USP

ID:

6401da8a-8cf3-72f6-e053-2991aa0ad5e0

Code:

34391-3

DESCRIPTION:


id: 6401da8a-8cda-72f6-e053-2991aa0ad5e0
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. Dispersibility of potassium chloride (KCI) is accomplished by microencapsulation 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, FD&C blue #1, FD&C red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triacetin.

CLINICAL PHARMACOLOGY:


id: 6401da8a-8cdb-72f6-e053-2991aa0ad5e0
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: 6401da8a-8cdc-72f6-e053-2991aa0ad5e0
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: 6401da8a-8cdd-72f6-e053-2991aa0ad5e0
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.

ADVERSE REACTIONS:


id: 6401da8a-8cee-72f6-e053-2991aa0ad5e0
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.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE:


id: 6401da8a-8cef-72f6-e053-2991aa0ad5e0
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: 6401da8a-8cf0-72f6-e053-2991aa0ad5e0
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: 6401da8a-8cf1-72f6-e053-2991aa0ad5e0
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Potassium Chloride Extended-release Capsules, USP, 8 mEq are white opaque capsules, imprinted with Andrx logo on the cap and 559 on the body, each containing 600mg microencapsulated potassium chloride (equivalent to 8 mEq K) in bottles of 90 (NDC 42291-678-90). Potassium Chloride Extended-release Capsules, USP, 10 mEq are dark blue opaque capsules, imprinted with Andrx logo on the cap and 560 on the body, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in bottles of 90 (42291-679-90), bottles of 500 (42291-679-50). Store at controlled room temperature, 20° to 25°C (68° to 77°F). [See USP Controlled Temperature].

Dispense in tight container. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 Mfg. Rev. 02/15      

AV Rev. 03/16 (P)

PRINCIPAL DISPLAY PANEL


id: 6401da8a-8cf2-72f6-e053-2991aa0ad5e0
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

AvKARE

NDC
42291-678-90

Potassium Chloride Extended-release Capsules USP

(600 mg)  8 mEq K

90 Capsules        Rx Only Potassium Chloride Extended-release capsules USP 8 mEq contain microencapsulated KCI and are designed to release the active ingredient over an 8-to-10-hour period.

Usual dosage: See accompanying package insert.

Dispense in a tight container as defined in the USP. Store at controlled room temperature, 20
o to25
oC (68
o to 77
oF). [See USP Controlled Room Temperature].

Keep this and all medication out of the reach of children. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 02/15          AV 01/16 (P) N3   42291-678-90   3 AvKARE

NDC 42291-679-90

Potassium Chloride Extended-release Capsules USP

(750 mg)  10 mEq K

500 Capsules        Rx Only Potassium Chloride Extended-release capsules USP 10 mEq contain microencapsulated KCI and are designed to release the active ingredient over an 8-to-10-hour period.

Usual dosage: See accompanying package insert.

Dispense in a tight container as defined in the USP.
Store at controlled room temperature, 20
o to25
oC (68
o to 77
oF). [See USP Controlled Room Temperature].

Keep this and all medication out of the reach of children. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 02/15          AV 01/16 (P) N3   42291-679-50   4