EFFER-K ORANGE

Description: Effer-K® 25 mEq TABLETS (Potassium Bicarbonate Effervescent Tablets for Oral Solution, USP) are intended for the preparation of an oral solution of potassium. Each tablet contains 2.5 g. potassium bicarbonate and 2.1 g. citric acid which in solution provides 25 mEq (978 mg) of elemental potassium as potassium citrate. Tablets also contain: SD flavors, microcrystalline cellulose, mineral oil, saccharine and talc. The orange tablets contain FD&C yellow No. 6 and FD&C yellow No, 6 lake. The lemon citrus tablets contain D&C yellow No. 10 and yellow No. 10 lake. The cherry berry tablets contain FD&C red No. 40 and FD&C red No. 40 lake. The unflavored tablets do not contain any natural or synthetic dyes, flavors or sweeteners. Tablets are one inch in diameter round, flat face on both sides with large bevels. "EK-25" is imprinted on one side of the tablets. Each tablet is foil-pouched with the product description on one side of the pouch and the lot number, expiration and barcode on the other.

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; potassiumlosing 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: Adults- One Effer-K ® flavored tablet, (Orange, Lemon Citrus or Cherry Berry) each containing 25 mEq (978 mg) of potassium, completely dissolved in 4 ounces of cold or ice water, 1 to 4 times daily, depending on the requirement of the patient. For Effer-K ® unflavored tablets (each containing 25 mEq (978 mg) of potassium) we recommend completely dissolving one tablet in 12 to 16 ounces of cold juice of the patient's choice. NOTE: It is suggested that any effervescent potassium tablets be taken with meals and sipped slowly over a 5 to 10 minute period.

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.

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.

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.

Effer-K ® 25 mEq TABLETS (Potassium Bicarbonate Effervescent Tablets for Oral Solution, USP). Each tablet in solution provides 25 mEq of elemental potassium as potassium citrate. Store below 40˚C (104˚F) preferably between 15˚ and 30˚C (59˚ and 86˚F), in original hermetic packaging. Tablets are one inch diameter round, flat face on both sides with large bevels. "EK 25" is imprinted one side of the tablets. Each tablet is pouched with the product description on one side of the pouch and the lot number, expiration date, and barcode on the other. NDC 51801-001-30 Orange-flavored, package of 30 tablets. NDC 51801-005-30 Lemon Citrus-flavored, package of 30 tablets. NDC 51801-001-40 Orange-flavored, package of 100 tablets. NDC 51801-006-30 Cherry Berry-flavored, package of 30 tablets. NDC 51801-007-30 Unflavored, package of 30 tablets. Nomax, Inc. St. Louis, MO 63123 - Made in USA MSN 015-031 Rev. 08/10