K-Vescent

Major Pharmaceuticals

Potassium Bicarbonate Effervescent Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• K-VESCENT DESCRIPTION
• CLINICAL PHARMACOLOGY
• K-VESCENT INDICATIONS AND USAGE
• K-VESCENT CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• K-VESCENT ADVERSE REACTIONS
• OVERDOSAGE
• K-VESCENT DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

K-VESCENT DESCRIPTION

CLINICAL PHARMACOLOGY

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.

K-VESCENT INDICATIONS AND USAGE

K-VESCENT CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

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.

K-VESCENT ADVERSE REACTIONS

OVERDOSAGE

K-VESCENT DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Box of 30 Tablets NDC 0904-2720-46

Box of 100 Tablets NDC 0904-2720-60

PRINCIPAL DISPLAY PANEL

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