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Citrapos/Citrapos XR

Citrapos/Citrapos XR Special Precautions

potassium citrate

Manufacturer:

Cooper Pharma

Distributor:

Corbridge

Marketer:

Ambica
Full Prescribing Info
Special Precautions
Hyperkalemia: In patients with impaired mechanisms for excreting potassium, Potassium Citrate tablet administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Potassium Citrate tablet 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.
Citrapos: Interaction with potassium-sparing diuretics: Concomitant administration of Potassium Citrate tablet 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. If there is severe vomiting, abdominal pain or gastrointestinal bleeding, Potassium Citrate tablet should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.
Precautions: Physicians should consider reminding the patient of the following: To take each dose without crushing, chewing or sucking the tablet, to take this medicine only as directed. This is especially important if the patient is also taking both diuretics and digitalis preparations, to check with physician if there is trouble swallowing tablets or if the tablet seems to stick in the throat, to check with the doctor at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.
Citrapos XR: Hyperkalemia: Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs.
Gastrointestinal Lesions: Because of reports of upper gastrointestinal mucosal lesions following administration of potassium chloride (wax-matrix), an endoscopic examination of the upper gastrointestinal mucosa was performed in 30 normal volunteers after they had taken glycopyrrolate 2 mg by mouth three times a day, Potassium Citrate 95 mEq/day, wax-matrix potassium chloride 96 mEq/day or wax-matrix placebo, in thrice daily schedule in the fasting state for one week. Potassium Citrate and the wax-matrix formulation of potassium chloride were indistinguishable but both were significantly more irritating than the wax-matrix placebo. In a subsequent, similar study, lesions were less severe when glycopyrrolate was omitted.
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 is limited, but a similar frequency of gastrointestinal lesions should be anticipated.
If there is severe vomiting, abdominal pain or gastrointestinal bleeding, Potassium Citrate should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.
Use in Children: Citrapos: Safety and effectiveness in children have not been established.
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