Potassium Citrate Extended-Release Tablets are a citrate salt of potassium indicated for the management of:
Renal tubular acidosis (RTA) with calcium stones ( 1.1 )
Hypocitraturic calcium oxalate nephrolithiasis of any etiology ( 1.2 )
Uric acid lithiasis with or without calcium stones ( 1.3 )
1.1Renal Tubular Acidosis (RTA) with Calcium Stones
Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies ( 14.1 )] .
1.2Hypocitraturic Calcium Oxalate Nephrolithiasis
of any Etiology Potassium citrate is indicated for the management of hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies ( 14.2 )] .
1.3Uric Acid Lithiasis with or without Calcium Stones
Potassium citrate is indicated for the management of uric acid lithiasis with or without calcium stones [see Clinical Studies ( 14.3 )] .
Gegenanzeigen
Potassium citrate extended-release tablets are contraindicated:
In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).
In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.
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In patients with peptic ulcer disease because of its ulcerogenic potential.
In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of potassium citrate to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from potassium citrate therapy might promote further bacterial growth.
In patients with renal insufficiency (glomerular filtration rate of less than 0.7 mL/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.
Patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia). Such conditions include chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown ( 4 )
Patients for whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture ( 4 )
Patients with peptic ulcer disease ( 4 )
Patients with active urinary tract infection ( 4 )
Patients with renal insufficiency (glomerular filtration rate of less than 0.7 mL/kg/min) ( 4 )
Warnhinweise und Vorsichtsmaßnahmen
Hyperkalemia: In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate extended-release tablets in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided ( 5.1 )
Gastrointestinal lesions: if there is severe vomiting, abdominal pain or gastrointestinal bleeding, potassium citrate extended-release tablets should be discontinued immediately and the possibility of bowel perforation or obstruction investigated ( 5.2 )
5.1Hyperkalemia
In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate extended-release tablets in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided.
Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs.
5.2Gastrointestinal Lesions
Solid dosage forms of potassium chlorides have produced stenotic and/or ulcerative lesions of the small bowel and deaths. These lesions are caused by a high local concentration of potassium ions in the region of the dissolving tablets, which injured the bowel. In addition, perhaps because wax-matrix preparations are not enteric-coated and release some of their potassium content in the stomach, there have been reports of upper gastrointestinal bleeding associated with these products.
The frequency of gastrointestinal lesions with wax-matrix potassium chloride products is estimated at one per 100,000 patient-years. Experience with potassium citrate extended-release tablets is limited, but a similar frequency of gastrointestinal lesions should be anticipated. If there is severe vomiting, abdominal pain or gastrointestinal bleeding, potassium citrate extended-release tablets should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.
Wechselwirkungen
The following drug interactions may occur with potassium citrate:
Potassium-sparing diuretics: concomitant administration should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia ( 7.1 )
Drugs that slow gastrointestinal transit time: These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts ( 7.2 )
Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia ( 7.3 )
Nonsteroidal anti-inflammatory drugs (NSAIDs): Monitor for hyperkalemia ( 7.4 )
7.1Potential Effects of Potassium Citrate on Other Drugs Potassium-sparing Diuretics:
Concomitant administration of potassium citrate extended-release tablets and a potassium-sparing diuretic (such as triamterene, spironolactone or amiloride) should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia.
7.2Potential Effects of Other Drugs on Potassium Citrate
Drugs that slow gastrointestinal transit time: These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts.
7.3Renin-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.
7.4Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
NSAIDs may produce potassium retention by reducing renal synthesis of prostagladin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.
Schwangerschaft und Stillzeit
8.1Pregnancy
Animal reproduction studies have not been conducted. It is also not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate extended-release tablets should be given to a pregnant woman only if clearly needed.
Nebenwirkungen
Some patients may develop minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These may be alleviated by taking the dose with meals or snacks or by reducing the dosage ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Postmarketing Experience
Some patients may develop minor gastrointestinal complaints during potassium citrate therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snacks, or by reducing the dosage. Patients may find intact matrices in their feces.
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