K-Vescent Efffervescent

Potassium ion is the principal intracellular cation of most body tissues.  Potassium ions participate in many essential physiological processes, such as the maintenance of intracellular tonicity, nerve impulse transmission, enzymatic reactions in intermediary metabolism, cardiac, skeletal and smooth muscle function, and the maintenance of normal renal function.

Potassium depletion may occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake.  Potassium depletion usually develops slowly as a result of lengthy therapy with oral diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition.  Depletion is additionally associated with severe diarrhea, accompanied by vomiting.  Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis.  Potassium depletion may result in fatigue, weakness, nausea, drowsiness, loss of appetite, edema, oliguria and chronic ileus with distention.  Potassium deficiency may be manifested by shallow breathing, lowered blood pressure, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, or other ECG changes, such as lengthened Q-T interval, depressed S-T segment, and depressed or inverted T-wave.  In advanced cases of potassium deficiency, flaccid paralysis and/or impaired ability to concentrate urine may be evident.

Potassium supplements are contraindicated for patients having hyperkalemia, since a further increase in serum potassium level in these patients can results in cardiac arrest.  Hyperkalemia may complicate any of the following conditions;chronic renal failure; systemic acidosis, such as diabetic acidosis, acute dehydration; extensive tissue breakdown, as in severe burns; adrenal insufficiency.  Hypokalemia should not be treated by the simultaneous use of potassium salts and a potassium sparing diuretic, such as spironolactone or triamterene, since the concomitant use of these medications can result in severe hyperkalmia.

General Precautions - The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting a cause for potassium depletion.  When interpreting the serum potassium concentration, the physician should be aware that acute alkalosis can cause hypokalemia without showing a deficit in total body potassium.  Acute acidosis can increase the serum potassium level to normal even with a reduced total body potassium.. Thus close attention to acid-base balance, serum electrolytes, the clinical status of the patient, and the ECG is required in the treatment of potassium depletion.

Information for Patients - Patients should be instructed to dissolve each tablet completely in the required amount of water to reduce the risk of gastrointestinal irritation associated with the oral use of concentrated potassium salt products.  Patients should not open foil pouch until time of use.

Laboratory Tests - Serum potassium determinations and ECG should be part of the frequent clinical evaluation of the patient.

Drug Interactions - Severe hyperkalemia can be produced by the simultaneous administration of potassium supplements and a potassium-sparing diuretic (see Contraindications).  Potassium supplements should be used carefully by patients who are using salt substitutes, because many of these substitutes contain large amounts of potassium.  This simultaneous use could produce hyperkalemia.

Usage in Pregnancy - Pregnancy Category C - Animal reproduction studies have not been conducted with this effervescent potassium product.  It is unknown whether this product can cause fetal harm when given to a pregnant woman or if it can affect reproductive capacity.  Pregnant women should be given this product only if it is clearly needed.

Nursing Mothers - Because many drugs are excreted in human milk, there exists the potential for serious adverse reactions in nursing infants from oral potassium supplements.  Therefore, it should be decided whether to discontinue nursing or to discontinue the drug, considering the importance of the drug to the mother.

Pediatric Use - Safety and effectiveness in children have not been established.

Box of 30 Tablets NDC 0904-2720-46

Box of 100 Tablets NDC 0904-2720-60

K-Vescent brand of
Potassium Bicarbonate Effervescent Tablets
(25 mEQ potassium)
Orange Flavor

K-VESCENT  EFFFERVESCENT potassium bicarbonate tablet, effervescent

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0904-2720(NDC:50201-2400) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM BICARBONATE (BICARBONATE ION) POTASSIUM BICARBONATE 25 meq

Inactive Ingredients Ingredient Name Strength SORBITOL 0.971 g CITRIC ACID MONOHYDRATE 1.4 g SACCHARIN SODIUM ANHYDROUS 0.039 g POLYETHYLENE GLYCOL 8000 0.103 g SODIUM BENZOATE 0.077 g

Product Characteristics Color ORANGE Score 2 pieces Shape ROUND Size 25mm Flavor ORANGE (Natural Orange Flavor NV-3103) Imprint Code T Contains

Packaging # Item Code Package Description 1 NDC:0904-2720-46 30 TABLET, EFFERVESCENT (30 TABLET) in 1 BOX 2 NDC:0904-2720-60 100 TABLET, EFFERVESCENT (100 TABLET) in 1 BOX

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/22/2005

Labeler - Major Pharmaceuticals (191427277)

Revised: 08/2012   Major Pharmaceuticals