Micro-K Extencaps

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Overview

What is Micro-K Extencaps?

Micro-K Extencaps Capsules and Micro-K 10 Extencaps Capsules 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, respectively.

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 patented 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 microcapsules. The resulting potassium chloride solution slowly diffuses outward through the membrane. Micro-K and Micro-K 10 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 edible ink, ethylcellulose, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide. May contain FD&C Red No. 40 and Yellow No. 6 aluminum lakes.

What does Micro-K Extencaps look like?

What are the available doses of Micro-K Extencaps?

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What should I talk to my health care provider before I take Micro-K Extencaps?

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How should I use Micro-K Extencaps?

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.

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.

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 mEq or more 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 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 ), Micro-K Extencaps 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.

What interacts with Micro-K Extencaps?

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What are the warnings of Micro-K Extencaps?

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What are the precautions of Micro-K Extencaps?

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What are the side effects of Micro-K Extencaps?

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What should I look out for while using Micro-K Extencaps?

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 ).

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.

What might happen if I take too much Micro-K Extencaps?

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 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.

How should I store and handle Micro-K Extencaps?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Micro-K Extencaps containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "Micro-K" on the cap and "Ther-Rx 010" on the body, packaged as follows: 64011-010-04 bottle of 100 capsules 64011-010-08 bottle of 500 capsules 64011-010-11 Dis-Co® unit dose packages of 100 capsules Micro-K 10 Extencaps containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "Micro-K 10" on the cap and "Ther-Rx 009" on the body, packaged as follows: 64011-009-04 bottle of 100 capsules 64011-009-08 bottle of 500 capsules 64011-009-11 Dis-Co® unit dose packages of 100 capsules Store at controlled room temperature 20°-25°C (68°-77°F).Dispense in tight container. Mktd. by Ther-Rx Corp. St. Louis, MO 63044 06/05P3511-4 Micro-K Extencaps containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "Micro-K" on the cap and "Ther-Rx 010" on the body, packaged as follows: 64011-010-04 bottle of 100 capsules 64011-010-08 bottle of 500 capsules 64011-010-11 Dis-Co® unit dose packages of 100 capsules Micro-K 10 Extencaps containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "Micro-K 10" on the cap and "Ther-Rx 009" on the body, packaged as follows: 64011-009-04 bottle of 100 capsules 64011-009-08 bottle of 500 capsules 64011-009-11 Dis-Co® unit dose packages of 100 capsules Store at controlled room temperature 20°-25°C (68°-77°F).Dispense in tight container. Mktd. by Ther-Rx Corp. St. Louis, MO 63044 06/05P3511-4 Micro-K Extencaps containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "Micro-K" on the cap and "Ther-Rx 010" on the body, packaged as follows: 64011-010-04 bottle of 100 capsules 64011-010-08 bottle of 500 capsules 64011-010-11 Dis-Co® unit dose packages of 100 capsules Micro-K 10 Extencaps containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "Micro-K 10" on the cap and "Ther-Rx 009" on the body, packaged as follows: 64011-009-04 bottle of 100 capsules 64011-009-08 bottle of 500 capsules 64011-009-11 Dis-Co® unit dose packages of 100 capsules Store at controlled room temperature 20°-25°C (68°-77°F).Dispense in tight container. Mktd. by Ther-Rx Corp. St. Louis, MO 63044 06/05P3511-4 Micro-K Extencaps containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "Micro-K" on the cap and "Ther-Rx 010" on the body, packaged as follows: 64011-010-04 bottle of 100 capsules 64011-010-08 bottle of 500 capsules 64011-010-11 Dis-Co® unit dose packages of 100 capsules Micro-K 10 Extencaps containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "Micro-K 10" on the cap and "Ther-Rx 009" on the body, packaged as follows: 64011-009-04 bottle of 100 capsules 64011-009-08 bottle of 500 capsules 64011-009-11 Dis-Co® unit dose packages of 100 capsules Store at controlled room temperature 20°-25°C (68°-77°F).Dispense in tight container. Mktd. by Ther-Rx Corp. St. Louis, MO 63044 06/05P3511-4 Micro-K Extencaps containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "Micro-K" on the cap and "Ther-Rx 010" on the body, packaged as follows: 64011-010-04 bottle of 100 capsules 64011-010-08 bottle of 500 capsules 64011-010-11 Dis-Co® unit dose packages of 100 capsules Micro-K 10 Extencaps containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "Micro-K 10" on the cap and "Ther-Rx 009" on the body, packaged as follows: 64011-009-04 bottle of 100 capsules 64011-009-08 bottle of 500 capsules 64011-009-11 Dis-Co® unit dose packages of 100 capsules Store at controlled room temperature 20°-25°C (68°-77°F).Dispense in tight container. Mktd. by Ther-Rx Corp. St. Louis, MO 63044 06/05P3511-4 Micro-K Extencaps containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "Micro-K" on the cap and "Ther-Rx 010" on the body, packaged as follows: 64011-010-04 bottle of 100 capsules 64011-010-08 bottle of 500 capsules 64011-010-11 Dis-Co® unit dose packages of 100 capsules Micro-K 10 Extencaps containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "Micro-K 10" on the cap and "Ther-Rx 009" on the body, packaged as follows: 64011-009-04 bottle of 100 capsules 64011-009-08 bottle of 500 capsules 64011-009-11 Dis-Co® unit dose packages of 100 capsules Store at controlled room temperature 20°-25°C (68°-77°F).Dispense in tight container. Mktd. by Ther-Rx Corp. St. Louis, MO 63044 06/05P3511-4

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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.

Non-Clinical Toxicology

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 ).

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.

Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see ).

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.

One of the most severe adverse effects is hyperkalemia (see , , and ). Gastrointestinal bleeding and ulceration have been reported in patients treated with Micro-K Extencaps (see and ). 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 Micro-K Extencaps.

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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