Complete SPL Sections#
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Potassium Chloride Extended-Release Tablets are 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.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Potassium Chloride Extended-Release Tablets, USP are supplied as: The 8 mEq (600 mg) tablets are white to off-white, round, biconvex, coated tablets, debossed with “YH” and “106” on one side, and “8” on the other side. The 10 mEq (750 mg) tablets are white to off-white, round, biconvex, coated tablets, debossed with “YH” and “105” on one side, and “10” on the other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Potassium chloride is contraindicated in patients on triamterene and amiloride.
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
11 DESCRIPTION
DESCRIPTION SECTION
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: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Potassium Chloride Extended-Release Tablets, USP contain 600 mg or 750 mg of Potassium Chloride, USP (equivalent to 8 mEq and 10 mEq respectively), and are provided as extended release tablets. Table 1: How Supplied Dose Shape Color Debossment Bottle of 100 tablets Bottle of 500 tablets Bottle of 1000 tablets 600 mg (8 mEq) Round White to off-white “YH” and “106” on one side, and “8” on the other side 42806-422-01 42806-422-05 42806-422-10 750 mg (10 mEq) Round White to off-white “YH” and “105” on one side, and “10” on the other side 42806-423-01 42806-423-05 42806-423-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [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.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
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.
REPACKAGING INFORMATION
SPL UNCLASSIFIED SECTION
Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: 10mEq (750mg) NDC 71610-945-30, Bottles of 30 Tablets NDC 71610-945-53, Bottles of 60 Tablets NDC 71610-945-60, Bottles of 90 Tablets NDC 71610-945-70, Bottles of 120 Tablets Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20250904AMH
PRINCIPAL DISPLAY PANEL - 10mEq (750mg)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 71610-945 - Potassium Chloride ER, USP 10mEq (750mg) Tablets - Rx Only