PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DRUG: Potassium Chloride

GENERIC: Potassium Chloride

DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2964-0

NDC: 70518-2964-1

NDC: 70518-2964-2

NDC: 70518-2964-3

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: N;32

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 BOTTLE PLASTIC

PACKAGING: 90 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

• POTASSIUM CHLORIDE 750mg in 1

INACTIVE INGREDIENT(S):

• SILICON DIOXIDE
• HYDROGENATED COTTONSEED OIL
• MAGNESIUM STEARATE
• POLYETHYLENE GLYCOL 4000
• POLYVINYL ALCOHOL, UNSPECIFIED
• TALC
• TITANIUM DIOXIDE

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DESCRIPTION SECTION

11 DESCRIPTION

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, crystalline 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 practically insoluble in ethanol.

Inactive Ingredients: Colloidal silicon dioxide, hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. In addition, the 8 mEq tablets contain iron oxide red.

FDA approved acceptance criteria for assay differs from USP test.

Meets USP Dissolution Test 5.

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INDICATIONS & USAGE SECTION

Highlight: Potassium chloride extended-release tablets are a potassium salt, 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. (1)

1 INDICATIONS AND USAGE

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.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Tablets: 750 mg (10 mEq) (3)

3 DOSAGE FORMS AND STRENGTHS

Potassium chloride extended-release tablets USP are supplied as:

750 mg (10 mEq) are white to off-white, circular, film-coated biconvex tablet debossed with “N 32” on one side and plain on other side.

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CONTRAINDICATIONS SECTION

Highlight: * Concomitant use with triamterene and amiloride (4)

4 CONTRAINDICATIONS

Potassium chloride is contraindicated in patients on triamterene and amiloride.

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USE IN SPECIFIC POPULATIONS SECTION

Highlight: * Cirrhosis: Initiate therapy at the low end of the dosing range (8.6)

• Renal Impairment: Initiate therapy at the low end of the dosing range (8.7)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm.

The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2 Lactation

Risk Summary

The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

8.4 Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

8.5 Geriatric Use

Clinical studies of potassium chloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6 Cirrhotics

Based on publish literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently [see Clinical Pharmacology (12.3)] .

8.7 Renal Impairment

Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions (7.2, 7.3)] . The serum potassium level should be monitored frequently. Renal function should be assessed periodically.

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ADVERSE REACTIONS SECTION

Highlight: * The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6 ADVERSE REACTIONS

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.

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INFORMATION FOR PATIENTS SECTION

17 PATIENT COUNSELING INFORMATION

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

• 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.

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

Potassium Chloride Extended-Release Tablets USP contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq and 10 mEq respectively. Potassium chloride is provided as extended-release tablets.

Potassium Chloride Extended-Release Tablets USP 750 mg (10 mEq) are white to off-white, circular, film-coated biconvex tablet debossed with “N 32” on one side and plain on other side.

NDC: 70518-2964-00

NDC: 70518-2964-01

NDC: 70518-2964-02

NDC: 70518-2964-03

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 BOTTLE PLASTIC

PACKAGING: 90 in 1 BOTTLE PLASTIC

Store at 20o to 25oC (68o to 77oF) [see USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container with a child-resistant closure.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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