Each Extended-Release tablet contains: Potassium Citrate (as Monohydrate), USP 1.080 g.
Pharmacology: Pharmacodynamics: Mechanism of Action: Metabolism of absorbed potassium citrate produces an alkaline load, raising urinary pH and increasing urinary citrate by augmenting citrate clearance. Thus, potassium citrate therapy appears to increase urinary citrate mainly by changing the renal handling of citrate. Increased urinary citrate and pH decrease calcium ion activity by increasing calcium complexation to dissociated anions and thus decreasing the saturation of calcium oxalate.
Potassium citrate also inhibits the crystallization and spontaneous nucleation of calcium oxalate and calcium phosphate in hypocitraturic calcium nephrolithiasis. However, potassium citrate does not alter the urinary saturation of calcium phosphate, because the effect of increased citrate complexation of calcium is antagonized by the rise in pH-dependent dissociation of phosphate. Calcium phosphate stones are more stable in alkaline urine.
Pharmacokinetics: Potassium citrate is absorbed and in the absence of a deficit of bicarbonate in the plasma, its ion are excreted in the urine, which is rendered alkaline and there is accompanying diuresis. It is metabolized, after absorption, to bicarbonate.
For the management of renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate, nephrolithiasis of any etiology and uric acid lithiasis with or without calcium stones.
Patients with Severe Hypocitraturia: Start the treatment with a dose of 60 mEq daily (6 tablets), divided into 3 takes daily. Or as prescribed by the physician.
Patients with Mild Hypocitraturia: Start the treatment with dose of 30 mEq daily (3 tablets), divided into 3 intakes daily. Or as prescribed by the physician.
It is recommended to take the tablets 30 minutes after meals. Approximately 24 hours after having started the treatment, make a determination of urinary citrate and pH and adjust the dose in accordance with the needs of the patient. If necessary, the mEq/day (10 tablets). Or as prescribed by the physician.
Should be taken with food or within 30 minutes after meals. Swallow whole, do not chew or crush.
Symptoms: The long-term administration in patients having a trend to retain potassium may produce hyperpotassemia. In advanced phase, muscular paralysis and cardiovascular collapse may be produced.
Treatment: The recommended treatment in case of hyperpotassemia is IV administration of 10% dextrose solution, containing insulin 10-12 units/1000 mL; correction of the possible acidosis with IV sodium bicarbonate and hemodialysis or peritoneal dialysis.
Renal insufficiency, persistent alkaline urinary infections, obstruction of the urinary tract, hyperpotassemia, adrenal insufficiency, respiratory or metabolic alkalosis, active peptic ulcer, intestinal obstruction, patients submitted to anticholinergics therapy and patients with slow gastric emptying.
In patients with altered potassium excretion mechanism, hyperpotassemia may appear. In patients with renal insufficiency, there is an increased risk of appearance of hyperpotassemia and for this reason; it is advised not to exceed the recommended doses.
It is advisable to carry out an evaluation of electrolytes eg, sodium, potassium, chloride and carbon dioxide, creatinine and hemogram every 4 hrs. It is recommended that the patients in treatment with Potassium Citrate follow a diet without salt and increase the intake of liquids.
Pregnancy Category C. It is not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Potassium citrate should be given to a pregnant woman only if clearly needed.
Slight gastrointestinal disorders may appear which can be palliated by means of concomitant administration with food.
Potassium Citrate must not be administered to patients receiving potassium-sparing diuretics (Triamterene, Spironolactone or Amiloride).
Store at temperatures not exceeding 30°C
A12BA02 - potassium citrate ; Belongs to the class of potassium-containing preparations. Used as dietary supplements.
ER tab 1.080 g (10 mEq) (off-white to creamy white oval-shaped, plain on one side and bisected on the other side) x 30's.