Pokonza - Potassium Chloride powder, For Solution
(Potassium Chloride)Pokonza - Potassium Chloride powder, For Solution Prescribing Information
POKONZA™ (Potassium Chloride for Oral Solution, USP) is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Dilute prior to administration. (
Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis.
The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms and the clinical status of the patient. Correct volume status, acid-base balance and electrolyte deficits as appropriate.
Dilute the contents of 1 pouch of POKONZA™ in at least 4 ounces of cold water
Take with meals or immediately after eating.
If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation.
May cause gastrointestinal irritation. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation
Monitor serum potassium and adjust dosage accordingly (
Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses: limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period.
Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels.
Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain.
Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy.
Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.
If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation (
Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis.
The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms and the clinical status of the patient. Correct volume status, acid-base balance and electrolyte deficits as appropriate.
Dilute the contents of 1 pouch of POKONZA™ in at least 4 ounces of cold water
Take with meals or immediately after eating.
If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation.
- Adults: Initial doses range from 40-100 mEq/day in 2-5 divided doses: limit doses to 40 mEq per dose. Total daily dose should not exceed 200 mEq ()
2.2 Adult DosingTreatment of hypokalemia:Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses: limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period.
Maintenance or ProphylaxisTypical dose is 20 mEq per day. Individualize dose based upon serum potassium levels.
Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain.
- Pediatric patients aged birth to 16 years old: 2-4 mEq/kg/day in divided doses; not to exceed 1 mEq/kg as a single dose or 40 mEq whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy. Total daily dose should not exceed 100 mEq ()
2.3 Pediatric DosingTreatment of hypokalemia:Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy.
Maintenance or ProphylaxisPediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.
- Adults: Typical dose is 20 mEq per day ()
2.2 Adult DosingTreatment of hypokalemia:Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses: limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period.
Maintenance or ProphylaxisTypical dose is 20 mEq per day. Individualize dose based upon serum potassium levels.
Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain.
- Pediatric patients aged birth to 16 years old: typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day ()
2.3 Pediatric DosingTreatment of hypokalemia:Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy.
Maintenance or ProphylaxisPediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.
Each 10 mEq pouch contains 0.75 g of potassium chloride supplying 10 mEq of potassium and 10 mEq of chloride.
Cirrhosis: Initiate therapy at the low end of the dosing range (
Clinical studies of POKONZA™ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Renal Impairment: Initiate therapy at the low end of the dosing range (
Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently.
POKONZA™ is contraindicated in patients on potassium sparing diuretics.
- Gastrointestinal Irritation:Dilute before use, take with meals ()
5.1 Gastrointestinal IrritationMay cause gastrointestinal irritation. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation
[see Dosage and Administration (2.1)].