Effer-K 20 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.

Dosage and administration Effer-K ® 10 mEq. Adults - one tablet (Cherry Vanilla or Unflavored) each containing 10 mEq. (391 mg) of elemental potassium, 1 to 4 times daily, depending on the requirement of the patient. Completely dissolve the Cherry Vanilla flavored tablet in 2 to 3 ounces (58 to 85 mL) of cold or ice water before drinking. Completely dissolve the Unflavored tablet in 2 to 3 ounces (58 to 85 mL) of cold juice of choice before drinking. Effer-K ® 20 mEq. Adults - one tablet (Orange Cream or Unflavored) each containing 20 mEq. (782 mg) of elemental potassium, 1 to 4 times daily, depending on the requirement of the patient. Completely dissolve the Orange Cream flavored tablet in 3 to 4 ounces (85 to 115 mL) of cold or ice water before drinking. Completely dissolved the Unflavored tablet in 3 to 4 ounces (85 to 115 mL) of cold juice of choice before drinking. NOTE: It is suggested that any effervescent potassium tablet be taken with meals and sipped slowly over a 5 to 10 minute period.

Warnings In patients with hyperkalemia and impaired mechanisms for excreting potassium the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment. Note: There is no conclusive evidence that potassium supplements lower blood pressure in hypertensive patients.

Contraindications Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Conditions predisposing to hyperkalemia include: chronic renal failure, acute metabolic acidosis, uncontrolled diabetes mellitus, esophageal compression or delayed gastric emptying or intestinal obstruction/stricture or peptic ulcer. Potassium supplements should be used with caution and only where medically indicated in patients with familial periodic paralysis, myotonia congenita or severe/complete heart block. IMPORTANT: Potassium supplements are contraindicated in patients receiving potassium-sparing diuretics (e.g. spironolactone, triamterene) since such use may produce severe hyperkalemia.

Drug Interactions The simultaneous administration of potassium supplements and a potassium-sparing diuretic can produce severe hyperkalemia (see Contraindications ). Potassium supplements should be used cautiously in patients who are using salt substitutes, because most of the latter contain substantial amounts of potassium. Such concomitant use could result in hyperkalemia. Moreover, the following drugs may produce unfavorable interactions when used concomitantly with potassium supplements: angiotension-converting enzyme (ACE) inhibitors, nonsteroid anti-inflammatory drugs (NSAIDs), beta-adrenergic blocking drugs, heparin, low-salt foods, other potassium containing medications, digitalis glycosides and others.

Usage in Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Effer-K ® 10mEq or 20 mEq Tablets (Effervescent Potassium Bicarbonate/ Citric Acid Tablets for Oral Solution, USP). It is also not known whether these products can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Effer-K ® 10mEq or 20mEq Tablets (Effervescent Potassium Bicarbonate/ Citric Acid Tablets for Oral Solution, USP) should be given to a pregnant woman only if clearly needed.

Nursing Mothers Although no studies have been done, it is presumed that potassium is excreted in human milk. Caution should be exercised when Effer-K ® 10mEq or 20mEq Tablets (Effervescent Potassium Bicarbonate/ Citric Acid Tablets for Oral Solution, USP) are administered to a nursing woman.

Adverse Reactions One of the most severe adverse effects is hyperkalemia (see Contraindications , Warnings and Overdosage ). The most common adverse reactions to oral potassium salts are nausea, vomiting, abdominal 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 dose. Skin rash has been reported rarely.