Urilit Tablet: Each Tablet Contains Potassium Citrate BP 1.08 gm.
Potassium citrate is used to treat a kidney stone condition called renal tubular acidosis.
Mode of action After given orally, the metabolism of absorbed citrate produces an alkaline load, which increases urinary pH and urinary citrate. In addition Potassium Citrate increases urinary potassium by approximately the amount contained in the medication. In some patients, Potassium Citrate causes a transient reduction in urinary calcium which produces the urine that is less conducive to the crystallization of stone-forming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine decreases calcium ion activity and thus the saturation of calcium oxalate. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate (brushite). The increase in urinary pH also decreases calcium ion activity and increases the ionization of uric acid to more soluble urate ion.
Pharmacokinetics After orally taken, the rise in urinary citrate following a single dose begins by the first hour and lasts for 12 hours. With multiple doses the rise in the citrate excretion reaches its peak by the third day. When the treatment is withdrawn, urinary citrate begins to decline toward the pre-treatment level on the first day. The rise in citrate excretion is directly dependent on the dosage. Following long-term treatment, potassium citrate at a dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by approximately 0.7 units. Potassium citrate is metabolized in liver to potassium bicarbonate and excreted through urine.
For the management of:
To restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 to 7.0.
Doses greater than 100 mEq/day have not been studied and should be avoided.
Serum electrolytes & complete blood count should be monitored every four months.
Use in children:
Safety and effectiveness in children have not been established.
Concomitant administration of Potassium citrate and a potassium-sparing diuretic should be best avoided, since the simultaneous administration of these agents can produce severe hyperkalaemia. Drugs that slow gastrointestinal transit time can be expected to increase the gastrointestinal irritation produced by potassium salts.
Over dosage Overdose symptoms include Diarrhea, nausea, vomiting, hypernoia (excessive mental activity), convulsions, hyperkalemia, alkalosis.
Treatment measures for hyperkalaemia include the following: (1) Elimination of potassium-rich foods, medications containing potassium, and of potassium-sparing diuretics; (2) Intravenous administration of 300 - 500 mL/h of 10% glucose solution containing 10 - 20 units of insulin/1000 mL (3) Correction of acidosis, if present, with intravenous sodium bicarbonate; and (4) Use of exchange resins, haemodialysis or peritoneal dialysis.
Animal reproduction studies have not been conducted. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed. The normal potassium ion content of human milk is about 13 mEq/L. It is not known if it has an effect on this content. Caution should be exercised when it is administered to a nursing woman.
In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalaemia and cardiac arrest. Irritation of the gastrointestinal tract may be alleviated by taking the dose with meals.
Store in a dry place and protected from light. Keep out of reach of children. Keep the container tightly closed.