POKONZA .75 g/.79g
Potassium Chloride · POWDER, FOR SOLUTION · Carwin Pharmaceutical Associates, LLC
POKONZA is a powder, for solution containing potassium chloride at .75 g/.79g, taken oral. Manufactured by Carwin Pharmaceutical Associates, LLC.
Key Facts
- Brand Name
- POKONZA
- Generic Name
- Potassium Chloride
- NDC Code (Product)
15370-305- Manufacturer
- Carwin Pharmaceutical Associates, LLC
- Strength
- .75 g/.79g
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA208019
- Marketing Start
- 09/19/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE POKONZA ® (Potasium 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. POKONZA ® (Potassium Chloride for Oral Solution, USP) is a potassium salt indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassiumrich foods or diuretic dose reduction is insufficient. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dilute prior to administration. ( 2.1 , 5.1 ) Monitor serum potassium and adjust dosage accordingly ( 2.2 , 2.3 ) If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation ( 2.1 ) Treatment of hypokalemia: 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 ) 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 ) Maintenance or Prophylaxis of hypokalemia: Adults: Typical dose is 20 mEq per day ( 2.2 ) Pediatric patients aged birth to 16 years old: typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day ( 2.3 ) 2.1 Administration and Monitoring Monitoring 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 t…
Contraindications
4 CONTRAINDICATIONS POKONZA ® is contraindicated in patients on potassium sparing diuretics. Concomitant use with potassium sparing diuretics. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Potassium sparing diuretics: Avoid concomitant use ( 7.1 ) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia ( 7.2 ) Nonsteroidal Anti-Inflammatory drugs: Monitor for hyperkalemia ( 7.3 ) 7.1 Potassium-Sparing Diuretics Use with potassium-sparing diuretics can produce severe hyperkalemia. Avoid concomitant use. 7.2 Renin-Angiotensin-Aldosterone System Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy. 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) NSAIDs may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Carwin Pharmaceutical Associates at 1-844-700-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.
Frequently Asked Questions
What is POKONZA used for?
POKONZA contains Potassium Chloride. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is POKONZA a controlled substance?
POKONZA is not classified as a controlled substance by the DEA.
What is the generic name for POKONZA?
The generic name for POKONZA is Potassium Chloride. There are 11 other brand versions of Potassium Chloride.
What is the NDC code for POKONZA .75 g/.79g?
The NDC (National Drug Code) for POKONZA .75 g/.79g is 15370-305, listed by Carwin Pharmaceutical Associates, LLC.
Other Potassium Brands
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- Potassium Chloride20 meq/182804-075
- Potassium Chloride1500 mg/10904-7293
- POTASSIUM CHLORIDE40 meq/30mL0904-7462
- Potassium Chloride400 meq/1000mL0990-7077
- Potassium Chloride750 mg/142806-423
- Potassium Chloride20 meq/143386-917
- Potassium Chloride10 meq/150090-6635
- Potassium Chloride750 mg/151655-463
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)