Potassium Chloride Extended-release Tablets, USP is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium chloride is contraindicated in patients on triamterene and amiloride.
Potassium chloride is contraindicated in patients on triamterene and amiloride.
Potassium Chloride Extended Release Tablets, USP are supplied as: Potassium Chloride Extended Release Tablets, USP 8 mEq [600mg] are blue colored, circular biconvex film coated tablets plain on one side and debossed "P8" on another side. Potassium Chloride Extended Release Tablets, USP 10 mEq [750mg] are yellow colored, circular biconvex film coated tablets plain on one side and debossed "P10" on another side.
Potassium Chloride Extended Release Tablets, USP 10 mEq [750mg] are yellow colored, circular biconvex film coated tablets plain on one side and debossed "P10" on another side. 750 mg potassium chloride (equivalent to 10 mEq) are available in bottles of 30 (NDC 51655-706-52). Store at 25ºC (77ºF) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight container as defined in the USP with a child resistant closure.
NDC: 51655-706-52
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 628953 | potassium chloride 10 MEQ (750 MG) Extended Release Oral Tablet | PSN | 2 |
| 628953 | potassium chloride 10 MEQ Extended Release Oral Tablet | SCD | 2 |
| 628953 | K+ Chloride 10 MEQ Extended Release Oral Tablet | SY | 2 |
| 628953 | Pot Chloride 10 MEQ Extended Release Oral Tablet | SY | 2 |
| 628953 | potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral Tablet | SY | 2 |
| 628953 | potassium chloride 750 MG Extended Release Oral Tablet | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| POTASSIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51655-706-52 | Potassium Chloride | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64380-861-06 | EA - Each | 64380-861 | ebf6f44f-41e0-4928-a9e8-bf45016e8ce8 | 1 | 2018-12-13 |
| 64380-861-07 | EA - Each | 64380-861 | 51b8ec68-4026-4ce5-bcdb-71ef87530286 | 1 | 2018-12-13 |
| 64380-861-08 | EA - Each | 64380-861 | c4fad470-d472-4b17-81d3-34f8fac779df | 1 | 2018-12-13 |
Potassium Chloride Extended-release Tablets, USP is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium Chloride Extended Release Tablets, USP are supplied as: Potassium Chloride Extended Release Tablets, USP 8 mEq [600mg] are blue colored, circular biconvex film coated tablets plain on one side and debossed "P8" on another side. Potassium Chloride Extended Release Tablets, USP 10 mEq [750mg] are yellow colored, circular biconvex film coated tablets plain on one side and debossed "P10" on another side.
Potassium chloride is contraindicated in patients on triamterene and amiloride.
The following adverse reactions have been identified with use of oral potassium salts. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. There have been reports hyperkalemia and of upper and lower gastrointestinal condition including obstruction, bleeding, ulceration, perforation. Skin rash has been reported rarely.
Potassium Chloride Extended-release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or 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. Inactive Ingredients: Hydrogenated Vegetable Oil Type 1, Ethylcellulose (10cP), Ethylcellulose (100cP), Silicon Dioxide, Talc, Magnesium Stearate. The 600 mg tablets also contain Polyvinyl Alcohol, Titanium dioxide, Macrogol / PEG, Talc, FD&C Blue #1 / Brilliant Blue FCF Aluminum Lake, FD&C Blue #2 / Indigo Carmine Al 3% - 5% and the 750 mg tablets also contain of Polyvinyl Alcohol, Titanium dioxide, Macrogol / PEG, Talc, FD&C Yellow #5 / Tartrazine Aluminum Lake and FD&C Yellow #6 / Sunset Yellow FCF Aluminum Lake. "FDA approved dissolution test specifications differ from USP." and "FDA approved acceptance criteria for assay differs from USP test."
Potassium Chloride Extended Release Tablets, USP 10 mEq [750mg] are yellow colored, circular biconvex film coated tablets plain on one side and debossed "P10" on another side. 750 mg potassium chloride (equivalent to 10 mEq) are available in bottles of 30 (NDC 51655-706-52). Store at 25ºC (77ºF) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight container as defined in the USP with a child resistant closure.
Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Inform patients that the wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed. Manufactured by Strides Pharma Science Limited. Bengaluru -562106, India. Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816 Revised 12/2019
NDC: 51655-706-52