Clinical Information
Gen. Code and Des.
1240 potassium bicarbonate/cit ac ORAL TABLET EFF 25 MEQ
GCN and Des.
56821 potassium bicarbonate/cit ac ORAL TABLET EFF 25 MEQ
Strength
25MEQ
Dose Form
TABLET, EFFERVESCENT
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
40120000 REPLACEMENT PREPARATIONS
Active Ingredients
2487 citric acid 77929
765 potassium bicarbonate 298146
Inactive Ingredients
10141 red dye
10143 yellow dye
2600 saccharin 81072
EFFER-K 10 MEQ UNFLAVORED- potassium bicarbonate tablet, effervescent
EFFER-K 10 MEQ CHERRY VANILLA- potassium bicarbonate tablet, effervescent
EFFER-K 20 MEQ UNFLAVORED- potassium bicarbonate tablet, effervescent
EFFER-K 20 MEQ ORANGE CREAM- potassium bicarbonate tablet, effervescent
Nomax Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Description
Effer-K� 10mEq and 20 mEq Tablets (Effervescent Potassium Bicarbonate/ Citric Acid Tablets for Oral Solution, USP) are intended for the preparation of an oral solution of potassium.
Each 10 mEq tablet contains 1.0g potassium bicarbonate and 0.84g citric acid which, after effervescing, provides a solution containing 10 mEq (391 mg) of elemental potassium as potassium citrate.
Each 20 mEq tablet contains 2.0g potassium bicarbonate and 1.68g citric acid which, after effervescing, provides a solution containing 20 mEq (782 mg) of elemental potassium as potassium citrate.
Tablets also contain maltodextrin, anhydrous dextrose and l-leucine. In addition, the flavored tablets contain SD flavors, and sucralose.
The 10 mEq Cherry Vanilla tablets contain FD&C Red #40 and the 20 mEq Orange Cream tablets contain FD&C Yellow #6 and FD&C Red #40. The Unflavored 10 and 20 mEq tablets do not contain any natural or synthetic dyes, flavors or sweeteners.
The 10 mEq tablets are 11/16 inch diameter round, flat face on both sides with large bevels. EK 10 is imprinted on one side. The 20 mEq tablets are 7/8 inch diameter round, flat face on both sides with large bevels. EK 20 is imprinted on one side. Each tablet is pouched with the product description on one side of the pouch and the lot number, expiration date and bar code on the other
Clinical Pharmacology
Potassium ion is the principal intracellular cation of most body tissues, whereas sodium ion is relatively low in concentration. In extracellular fluid the opposite exists, sodium ion being principal and potassium ion being low. The situation is maintained by an active membrane-bound enzyme (Na+ K+ ATPase). This potassium ion concentration gradient is essential to conduct nerve impulses in such specialized tissues as the brain, heart, and skeletal muscle; and in addition, to maintain normal renal function, acid-base balance, and various cellular metabolic functions. Elimination values are 90% renal and 10% fecal.
Potassium depletion may occur if the rate of potassium ion loss by renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium ion intake. Such depletion usually develops slowly as a consequence of prolonged therapy with oral diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, severe diarrhea, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Potassium depletion due to these causes is usually accompanied by a concomitant deficiency of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, mood or mental changes, nausea, vomiting, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases flaccid paralysis and/or impaired ability to concentrate urine.
Effer-K 10 MEq Unflavored Indications and Usage
For therapeutic use in patients with hypokalemia with or without metabolic alkalosis; in chronic digitalis intoxication; and in patients with hypokalemic familial periodic paralysis.
For prevention of potassium depletion when the dietary intake of potassium ion is inadequate in the following conditions; patients receiving digitalis and diuretics for congestive heart failure; hepatic cirrhosis with ascites; states of aldosterone excess with normal renal function; potassium-losing nephropathy, and certain diarrheal states; long-term corticosteroid therapy.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension or receiving certain antibiotics is often unnecessary when such patients have a normal dietary pattern. Serum potassium should be checked periodically, however, and, if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases supplementation with potassium salts may be indicated.
