K-DUR (Page 2 of 2)

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

PRECAUTIONS

General

The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

Information for Patients

Physicians should consider reminding the patient of the following:

To take each dose with meals and with a full glass of water or other liquid.

To take each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration:

  1. Break the tablet in half, and take each half separately with a glass of water.
  2. Prepare an aqueous (water) suspension as follows:
    1. Place the whole tablet(s) in approximately ½ glass of water (4 fluid ounces).
    2. Allow approximately 2 minutes for the tablet(s) to disintegrate.
    3. Stir for about half a minute after the tablet(s) has disintegrated.
    4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
    5. Add another 1 fluid ounce of water, swirl, and consume immediately.
    6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of K-DUR tablets that is not taken immediately should be discarded. The use of other liquids for suspending K-DUR tablets is not recommended.

To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.

To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Laboratory Tests

When blood is drawn for analysis of plasma potassium it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Drug Interactions

Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with K-DUR. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, and 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.

OVERDOSAGE

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5–8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9–12 mEq/L).

Treatment measures for hyperkalemia include the following:

  1. Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties.
  2. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10–20 units of crystalline insulin per 1,000 mL.
  3. Correction of acidosis, if present, with intravenous sodium bicarbonate.
  4. Use of exchange resins, hemodialysis, or peritoneal dialysis.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

DOSAGE AND 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 40–100 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 K-DUR 20 tablet provides 20 mEq of potassium chloride.

Each K-DUR 10 tablet provides 10 mEq of potassium chloride.

K-DUR 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:

  1. Break the tablet in half, and take each half separately with a glass of water.
  2. Prepare an aqueous (water) suspension as follows:
    1. Place the whole tablet(s) in approximately ½ glass of water (4 fluid ounces).
    2. Allow approximately 2 minutes for the tablet(s) to disintegrate.
    3. Stir for about half a minute after the tablet(s) has disintegrated.
    4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
    5. Add another 1 fluid ounce of water, swirl, and consume immediately.
    6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of K-DUR tablets that is not taken immediately should be discarded. The use of other liquids for suspending K-DUR tablets is not recommended.

HOW SUPPLIED

K-DUR 20 mEq Extended Release Tablets are available in bottles of 100 (NDC 0085-0787-01); bottles of 500 (NDC 0085-0787-06); bottles of 1000 (NDC 0085-0787-10); and boxes of 100 for unit dose dispensing (NDC 0085-0787-81). K-DUR 20 mEq tablets are white to off-white mottled capsule-shaped tablets, imprinted “K-DUR 20″ and scored on the other side for flexibility of dosing.

K-DUR 10 mEq Extended Release Tablets are available in bottles of 100 (NDC 0085-0263-01) and boxes of 100 for unit dose dispensing (NDC 0085-0263-81). K-DUR 10 mEq tablets are white to off-white mottled capsule-shaped tablets, imprinted “K-DUR 10″ on one side and plain on the other.

Storage Conditions

Keep tightly closed.

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]

Rx only.

Image from Drug Label Content
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Copyright © 1986, 1989, 1990, Key Pharmaceuticals, Inc. All rights reserved.

Rev. 4/04
24206726T

K-DUR
potassium chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-0787
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Potassium Chloride (Potassium Chloride) Potassium Chloride 1500 mg
Inactive Ingredients
Ingredient Name Strength
Crospovidine
Ethyl-cellulose
Hydroxypropyl Cellulose
Magnesium Stearate
Microcrystalline Cellulose
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL (capsule shaped) Size 20mm
Flavor Imprint Code K-DUR;20
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0085-0787-01 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE None
2 NDC:0085-0787-06 500 TABLET, EXTENDED RELEASE (500 TABLET) in 1 BOTTLE None
3 NDC:0085-0787-10 1000 TABLET, EXTENDED RELEASE (1000 TABLET) in 1 BOTTLE None
4 NDC:0085-0787-81 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOX, UNIT-DOSE None
K-DUR
potassium chloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-0263
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Potassium Chloride (Potassium Chloride) Potassium Chloride 750 mg
Inactive Ingredients
Ingredient Name Strength
Crospovidine
Ethyl-cellulose
Hydroxypropyl Cellulose
Magnesium Stearate
Microcrystalline Cellulose
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL (capsule shaped) Size 15mm
Flavor Imprint Code K-DUR;10
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0085-0263-01 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE None
2 NDC:0085-0263-81 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOX, UNIT-DOSE None
Labeler — Key Pharmaceuticals, Inc.

Revised: 03/2007 Key Pharmaceuticals, Inc.

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