Potassium Chloride (Klor-Con M)

Trade Name : KLOR-CON M

Aphena Pharma Solutions - Tennessee, LLC

TABLET, EXTENDED RELEASE

Strength 1500 mg/1

POTASSIUM CHLORIDE Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Potassium Chloride (Klor-Con M) which is also known as KLOR-CON M and Manufactured by Aphena Pharma Solutions - Tennessee, LLC. It is available in strength of 1500 mg/1 per ml. Read more

Potassium Chloride (Klor-Con M) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Rx only

Klor-Con M20 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet.
Klor-Con M15 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet.
Klor-Con M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet.
These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced.
Klor-Con M is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. 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.
Klor-Con M is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37u00b0C and in the absence of outside agitation, Klor-Con M begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride.
Inactive Ingredients:

The 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 as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, 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 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 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.

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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.
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.

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, or amiloride) (see ).
Extended-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Klor-Con M (see and sections).
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 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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One of the most severe adverse effects is hyperkalemia (see and ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see and ). The most common adverse reactions to oral potassium 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.

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 and ). 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 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:

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 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 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.
Each Klor-Con M20 tablet provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium.
Each Klor-Con M15 tablet provides 1125 mg of potassium chloride equivalent to 15 mEq of potassium.
Each Klor-Con M10 tablet provides 750 mg of potassium chloride equivalent to 10 mEq of potassium.
Klor-Con M tablets 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 ).
Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:

Klor-Con M20 Extended-release Tablets, 1500 mg of potassium chloride (20 mEq of potassium) are available in bottles of 90 (NDC 66758-190-92); bottles of 100 (NDC 66758-190-01); bottles of 500 (NDC 66758-190-05); bottles of 1000 (NDC 66758-190-10); and cartons of 100 for unit dose dispensing (NDC 66758-190-13). Klor-Con M20 tablets are white, oblong, imprinted KC M20 and scored for flexibility of dosing.
Klor-Con M15 Extended-release Tablets, 1125 mg of potassium chloride (15 mEq of potassium) are available in bottles of 100 (NDC 66758-180-01); bottles of 1000 (NDC 66758-180-10); and cartons of 100 for unit dose dispensing (NDC 66758- 180-13). Klor-Con M15 tablets are white, oblong, imprinted M 15 and scored for flexibility of dosing.
Klor-Con M10 Extended-release Tablets, 750 mg of potassium chloride (10 mEq of potassium) are available in bottles of 90 (NDC 66758-170-92); bottles of 100 (NDC 66758-170-01); bottles of 1000 (NDC 66758-170-10); and cartons of 100 for unit dose dispensing (NDC 66758-170-13). Klor-Con M10 tablets are white, oblong and imprinted KC M10.
Keep tightly closed. Store at 20-25u00b0C (68-77u00b0F). Excursions permitted to 15-30u00b0C (59-86u00b0F). [See USP Controlled Room Temperature.]

Manufactured byn n Maple Grove, MN 55369 for n n Princeton, NJ 08540
Klor-Con and Micro-Dispersible are registered trademarks of Upsher-Smith Laboratories, Inc.
US Patent 6,780,437
Certain manufacturing operations have been performed by other firms.
Revised 0414

Please reference the section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Store between 20u00b0-25u00b0C (68u00b0-77u00b0F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:n n Cookeville, TN 38506n 20171219JH

NDC
Klor-Con M10Potassium ChlorideExtended-releaseTablets, USP
MICRO-DISPERSIBLE TECHNOLOGY
10 mEq K
Rx only
90 Tablets

NDC
Klor-Con M20Potassium ChlorideExtended-releaseTablets, USP
MICRO-DISPERSIBLE TECHNOLOGY
20 mEq K
Rx only
90 Tablets

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Potassium Chloride (Klor-Con M)

Trade Name : KLOR-CON M

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Potassium Chloride (Klor-Con M)

Trade Name : KLOR-CON M

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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