K-Dur

Potassium chloride is a prescription medication used to treat and prevent low potassium levels due to poor dietary intake, certain diseases, or other drugs. Potassium chloride belongs to a group of drugs called electrolytes, which are compounds that help the body function normally.

This medication comes in tablet and capsule forms and may be taken multiple times a day with food and water.

This medication is also available in an injectable form to be given directly into a vein by a healthcare professional.

Common side effects of potassium chloride include nausea, vomiting, stomach discomfort or pain, and diarrhea.

Potassium chloride is a prescription medication used to treat and prevent low potassium levels due to poor dietary intake, certain diseases, or other drugs.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with potassium chloride. See “Drug Precautions” section.

Common side effects of potassium chloride include:

• nausea
• vomiting
• diarrhea
• gas
• abdominal pain

This is not a complete list of potassium chloride side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in potassium chloride is excreted in human breast milk. The effect of potassium chloride on the nursing infant is not known.

The K-Dur® 20 product 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.

The K-Dur® 10 product 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.

K-Dur 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.

K-Dur 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 37°C and in the absence of outside agitation, K-Dur begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride.

Inactive Ingredients: Crospovidone, Ethyl-cellulose, Hydroxypropyl Cellulose, Magnesium Stearate, and Microcrystalline Cellulose.

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.

1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, 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, eg, digitalized patients or patients with significant cardiac arrhythmias.

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 (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE).

Controlled 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 K-Dur (see PRECAUTIONS: Information for Patients, and DOSAGE AND ADMINISTRATION sections).

All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (eg, 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include irregular heartbeats, chest pain, or muscle weakness.

Usual Adult Dose for Hypokalemia:

Oral:
40 to 100 mEq per day, orally, in 2 to 5 divided doses
Maximum single dose: 20 mEq per dose
Maximum daily dose: 200 mEq

The usual adult dietary intake is 50 to 100 mEq potassium per day.

-Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 mEq or more of the total body stores of potassium.

Usual Adult Dose for Prevention of Hypokalemia:

Oral:
Typical dose: 20 mEq, orally, daily
-Individualize dose based on serum potassium levels
-Divide dose if more than 20 mEq per day is used

-The usual adult dietary intake is 50 to 100 mEq potassium per day.

Applies to potassium chloride: compounding powder, intravenous solution, oral capsule extended release, oral granule extended release, oral liquid, oral powder for reconstitution, oral tablet, oral tablet extended release

Metabolic

Hyperkalemia can cause muscle weakness, paresthesia of the extremities, listlessness, mental confusion, flaccid paralysis, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, paralysis, cardiac arrhythmias, and heart block. Electrocardiogram abnormalities include disappearance of the P-wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T-waves. At extremely high concentrations (8 to 11 mmol/L) may cause death from cardiac depression, arrhythmias, or arrest.[Ref]

Frequency not reported: Hyperkalemia, hypervolemia[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, flatulence, abdominal pain/discomfort, diarrhea, obstruction, bleeding, ulceration, perforation, gastrointestinal hemorrhage, local irritation of the mucosa
Postmarketing reports: Delayed intestinal transit[Ref]

Local

Frequency not reported: Injection site pain, injection site phlebitis, infection at injection site, venous thrombosis extending from site of injection, extravasation[Ref]

Cardiovascular

Frequency not reported: Cardiac arrhythmias, cardiac arrest[Ref]

Dermatologic

Rare (less than 0.1%): Skin rash
Frequency not reported: Urticaria, pruritus[Ref]

Other

Frequency not reported: Febrile response[Ref]

Some side effects of K-Dur may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.