Potassium Chloride ER 1500 mg/1
Potassium Chloride ER · TABLET, EXTENDED RELEASE · Direct_Rx
Potassium Chloride ER is a tablet, extended release containing potassium chloride er at 1500 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Potassium Chloride ER
- Generic Name
- Potassium Chloride ER
- NDC Code (Product)
72189-462- Manufacturer
- Direct_Rx
- Strength
- 1500 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203562
- Marketing Start
- 04/17/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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, e.g., 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 supplement…
Dosage & Administration
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 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. Each potassium chloride extended release tablets 10 mEq provides 750 mg of potassium chloride equivalent to 10 mEq of potassium. Each potassium chloride extended release tablets 20 mEq provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium chloride. Potassium chloride extended release 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 WARNINGS]. Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:…
Warnings
Hyperkalemia [see OVERDOSAGE] In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment. Interaction with Potassium-Sparing Diuretics Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia. Interaction with Renin Angiotensin-Aldosterone System Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce po…
Contraindications
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 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 potassium chloride [see PRECAUTIONS: Information for Patients and DOSAGE AND ADMINISTRATION]. 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 t…
Adverse Reactions
One of the most severe adverse effects is hyperkalemia [see CONTRAINDICATIONS, WARNINGSand OVERDOSAGE]. There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation [see CONTRAINDICATIONS and WARNINGS].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.
Frequently Asked Questions
What is Potassium Chloride ER used for?
Potassium Chloride ER contains Potassium Chloride ER. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Potassium Chloride ER a controlled substance?
Potassium Chloride ER is not classified as a controlled substance by the DEA.
What is the generic name for Potassium Chloride ER?
The generic name for Potassium Chloride ER is Potassium Chloride ER. There are no other listed brand versions of Potassium Chloride ER.
What is the NDC code for Potassium Chloride ER 1500 mg/1?
The NDC (National Drug Code) for Potassium Chloride ER 1500 mg/1 is 72189-462, listed by Direct_Rx.
Other Potassium Chloride ER Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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