Specific urinary drugs
Potassium Bicarbonate 967,5 mg
8Sachets
Sa-05
926/2018
23/12/2018
Excipients | Each one sachet (5 g) contains :Potassium Bicarbonate 967.5 mg(12.9 mEq ) , 1.5 mg (20 mEq ) . |
INDICATIONS | 1) For therapeutic use in patients with hypokalemia with or without metabolic alkalosis; in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. 2) For prevention of potassium depletion when the dietary intake of potassium 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. 3) The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension 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 |
CONTRAINDICATIONS | Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce 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, or the administration of a potassium-sparing diuretic (e.g., spironolactone, triamterene or amiloride). Contraindicated in persons demonstrating allergy to any of the components of the powder.Side Effects: |
Side EFFECTS | 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. One of the most severe adverse effects is hyperkalemia (see Contraindications, Warnings and Overdosage). Skin rash has been reported rarely. |
WARNINGS | Hyperkalemia: 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 adjustments. 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. Metabolic Acidosis: Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate or potassium acetate. Precautions: General: The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. Laboratory Tests: In interpreting the serum potassium level, the physician should be aware that acute alkalosis per se can produce hypokalemia in the absence of adeficit 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. |
Pregnancy And lactations | : Pregnancy Category C Animal reproduction studies have not been conducted with potassium chloride. It is not known if potassium chloride causes fetal harm whenadministered to a pregnant woman or affects reproductive capacity. Potassium chloride should be given to a pregnant woman only if clearly needetions Nursing Mothers: Many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from oral potassium supplements,a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
Dosage And Administration | Dosage must be adjusted to the individual needs of each patient but is typically in the range of 20 mEq per day for the prevention of hypokalemia to40-100 mEq per day or more for the treatment of potassium depletion. The usual adult dose is 20-100 mEq of potassium per day (one POTASSIUM CHLORIDE POWDER FOR ORAL SOLUTION, USP 20 mEq packet 1to 5 times daily after meals). The contents of each POTASSIUM CHLORIDE POWDER FOR ORAL SOLUTION, USP 20 mEq packet should be dissolved in at least 4 ounces of cold water or other beverage. These preparations, like other potassium supplements, must be properly diluted to avoid the possibility of gastrointestinal irritation. |
OVERDOSE | The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see Contraindications and Warnings). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest. Treatment measures for hyperkalemia include the following: (1) elimination of foods and medications containing potassium and of potassium-sparing diuretics; (2) intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of insulin per 1000 mL; (3) correction of acidosis, if present, with intravenous sodium bicarbonate; (4) use of exchange resins, hemodialysis or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. |
Storage Conditions | Store at room temperature (15 – 30) ° C. Keep out of reach out of children |