POTASSIUM BICARBONATE: 16 Adverse Event Reports & Safety Profile

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

INDICATIONS AND USAGE For the treatment of patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop (e.g., digitalized patients or patients with significant cardiac arrhythmias). The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. 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, and if dose adjustment of the diuretic is ineffective or unwarranted, 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.

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.

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.

WARNINGS Hyperkalemia [see OVERDOSAGE ] In patients with 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. Interaction with Potassium-Sparing Diuretics Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene or amiloride), since the simultaneous administration of these agents can produce severe hyperkalemia. Interaction with Angiotensin Converting Enzyme Inhibitors Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate or potassium gluconate.

Precautions The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium, while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient. Information for patients To minimize the possibility of gastrointestinal irritation associated with the oral ingestion of concentrated potassium salt preparations, patients should be directed to dissolve each dose completely in the stated amount of water. Each dose should be taken immediately after a meal or with food. Patients should avoid low-salt foods and salt substitutes, unless approved by physician. The patient should be cautioned to comply strictly with the regimen, particularly when taking diuretics or digitalis, to visit the physician regularly and to report at once any unusual symptoms (e.g. blackish stools, a sign of gastrointestinal bleeding). As with any other medicine, the patient should be counseled on this background information and advised to report to the physician any changes in routine (e.g. starting a fitness program). Proper storage and handling of the product is important. Tablets should not be removed from foil pouch until shortly before use. Laboratory tests Frequent clinical evaluation of the patient should include an ECG and a serum potassium level; also, as appropriate, renal function, serum magnesium and serum pH.

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. Carcinogenesis, Mutagenesis, Impairment of Fertility Potassium is an essential constituent of the human diet. There are no data available on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility in animals or in human beings. 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. Labor and Delivery Information unknown.

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. Usage in Children Safety and effectiveness in children have not been established.

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.