K10

A white crystal or crystalline powder used as an electrolyte replenisher, in the treatment of hypokalemia, in buffer solutions, and in fertilizers and explosives.

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE K10 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.

1. 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.
2. 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.

K10 (K10) is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.

K10 contains Potassium Chloride. Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

K10 may also be used for other purposes not listed here.

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, K10 (K10 extended-release) ® 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.

How supplied

K10 (K10 extended-release) ® Extencaps® are pale orange capsules monogrammed K10 (K10 extended-release) ® and "Ther-Rx"/ "010", each containing 600 mg microencapsulated K10 (equivalent to 8 mEq K) in bottles of 100 (NDC 64011-010-04), 500 (NDC 64011-010-08) and Dis-Co® unit dose packs of 100 (NDC 64011-010-11).

K10 (K10 extended-release) ® 10 Extencaps® are pale orange and opaque white capsules monogrammed K10 (K10 extended-release) ® 10 and "Ther-Rx"/"009", each containing 750 mg microencapsulated K10 (equivalent to 10 mEq K) in bottles of 100 (NDC 64011-009-04), 100 Unit-of-Use (NDC 64011-009-21), bottles of 500 (NDC 64011-009-08), and Dis-Co® unit dose packs of 100 (NDC 64011-009-11).

Store at controlled room temperature, between 20° C and 25° C (68° F and 77° F).

Dispense in tight container.

Manufactured by KV Pharmaceutical

for Ther-Rx Corporation., St. Louis, MO 63045

FDA rev date: 8/20/2003

See also:
What is the most important information I should know about K10?

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.

K10 (K10 extended-release tablets) tablets are contraindicated in patients with known hypersensitivity to any ingredient in this product.

Controlled-release formulations of K10 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 K10 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.

Use K10 solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• K10 solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using K10 solution at home, a health care provider will teach you how to use it. Be sure you understand how to use K10 solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use K10 solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• K10 solution MUST be diluted before use.
• It is very important to carefully check that the right amount of medicine is drawn into the syringe before injecting the medicine into its diluent solution.
• If this solution is given by way of a pumping device, be sure to stop the pumping action before the container runs dry or air embolism may occur.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of K10 solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use K10 solution.

This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with "water pills"/diuretics.

How to use K10

Take this medication by mouth as directed by your doctor. To prevent stomach upset, take each dose with a meal and a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this medication.

Do not crush, chew, or suck extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Swallow the capsules whole. If you have trouble swallowing the capsules, tell your doctor or pharmacist. Some brands may be opened and the contents sprinkled onto a spoonful of cool, soft food such as applesauce or pudding. Immediately swallow the food/medication mixture without chewing. Do not prepare the mixture ahead of time. Drink a glass of cool water after each dose to make sure you swallow all the medication. Ask your pharmacist if you have questions about your brand.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed. Do not take more than 20 milliequivalents per dose.

Tell your doctor if your condition does not improve or if you have symptoms of low potassium in the blood (such as irregular heartbeat, muscle weakness/cramps).

See also:
What other drugs will affect K10?

Aliskiren: Potassium Salts may enhance the hyperkalemic effect of Aliskiren. Monitor therapy

Angiotensin II Receptor Blockers: Potassium Salts may enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Potassium Salts may enhance the hyperkalemic effect of Angiotensin-Converting Enzyme Inhibitors. Monitor therapy

Anticholinergic Agents: May enhance the ulcerogenic effect of K10. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of K10. Avoid combination

Drospirenone: Potassium Salts may enhance the hyperkalemic effect of Drospirenone. Monitor therapy

Eplerenone: May enhance the hyperkalemic effect of Potassium Salts. Management: This combination is contraindicated in patients receiving eplerenone for treatment of hypertension. Consider therapy modification

Glycopyrrolate (Systemic): May enhance the adverse/toxic effect of K10. This is specific to solid oral dosage forms of K10. Avoid combination

Heparin: May enhance the hyperkalemic effect of Potassium Salts. Monitor therapy

Heparins (Low Molecular Weight): May enhance the hyperkalemic effect of Potassium Salts. Monitor therapy

Nicorandil: May enhance the hyperkalemic effect of Potassium Salts. Monitor therapy

Potassium-Sparing Diuretics: Potassium Salts may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Management: Avoid coadministration of a potassium-sparing diuretic and a potassium salt. This combination should only be used in cases of significant hypokalemia, and only if serum potassium can be closely monitored. Consider therapy modification

See also:
What are the possible side effects of K10?

One of the most severe adverse effects is hyperkalemia. Gastrointestinal bleeding and ulceration have been reported in patients treated with K10 (K10 extended-release) ® Extencaps®. In addition to gastrointestinal bleeding and ulceration, perforation and obstruction have been reported in patients treated with other solid KCl dosage forms, and may occur with K10 (K10 extended-release) ® 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.