Urocit-K

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• confusion, anxiety, feeling like you might pass out;
• uneven heartbeat;
• extreme thirst, increased urination;
• leg discomfort;
• muscle weakness or limp feeling;
• numbness or tingly feeling in your hands or feet, or around your mouth;
• severe stomach pain, ongoing diarrhea or vomiting;
• black, bloody, or tarry stools; or
• coughing up blood or vomit that looks like coffee grounds.

Less serious side effects may include:

• mild nausea or upset stomach;
• mild or occasional diarrhea; or
• appearance of a potassium citrate tablet in your stool.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

Potassium citrate is used to treat a kidney stone condition called renal tubular acidosis.

Potassium citrate may also be used for other purposes other than those listed in this medication guide.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include heavy feeling in your arms or legs, muscle weakness, limp feeling, slow or uneven heartbeat, chest pain, or feeling like you might pass out.

Urocit®-K is 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.
• 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 Urocit®-K to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Urocit®-K 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.

Hyperkalemia

In patients with impaired mechanisms for excreting potassium, Urocit®-K administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Urocit®-K 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.

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 p.o. t.i.d., Urocit®-K 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. Urocit®-K 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 Urocit®-K is limited, but a similar frequency of gastrointestinal lesions should be anticipated.

If there is severe vomiting, abdominal pain or gastrointestinal bleeding, Urocit®-K should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.

Treatment of Overdosage: The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest.

Treatment measures for hyperkalemia include the following:

1. Patients should be closely monitored for arrhythmias and electrolyte changes.
2. Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others.
3. Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.
4. Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
5. Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
6. Correction of acidosis, if present, with intravenous sodium bicarbonate.
7. Hemodialysis or peritoneal dialysis.
8. Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia.

Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.

Urocit®-K is a citrate salt of potassium. Its empirical formula is K3C6H5O7 • H2O, and it has the following chemical structure:

Urocit®-K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.

1. Pak, C. (1987). Citrate and Renal Calculi. Mineral and Electrolyte Metabolism 13, 257-266.
2. Pak, C. (1985). Long-Term Treatment of Calcium Nephrolithiasis with Potassium Citrate. The Journal of Urology 134, 11-19.
3. Preminger, G.M., K. Sakhaee, C. Skurla and C.Y.C. Pak. (1985). Prevention of Recurrent Calcium Stone Formation with Potassium Citrate Therapy in Patients with Distal Renal Tubular Acidosis. The Journal of Urology 134, 20-23.
4. Pak, C.Y.C., K. Sakhaee and C. Fuller. (1986). Successful Management of Uric Acid Nephrolithiasis with Potassium Citrate. Kidney International 30, 422-428.
5. Hollander-Rodriguez, J et al. (2006). Hyperkalemia, American Family Physician, Vol. 73/No. 2.
6. Greenberg, A et al. (1998). Hyperkalemia: treatment options. Semen Nephrol. Jan; 18 (1): 46-57.

Administration of Drug

Tell patients to take each dose without crushing, chewing or sucking the tablet.

Tell patients to take this medicine only as directed. This is especially important if the patient is also taking both diuretics and digitalis preparations.

Tell patients to check with the doctor if there is trouble swallowing tablets or if the tablet seems to stick in the throat.

Tell patients to check with the doctor at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Tell patients that their doctor will perform regular blood tests and electrocardiograms to ensure safety.

KP-503 C01 Rev 012090

MISSION PHARMACAL COMPANY, SAN ANTONIO, TX USA 78230 1355

PRINCIPAL DISPLAY PANEL - 5 mEq Bottle Label

NDC 0178-0600-01

UROCIT®-K

5 mEq

(Potassium Citrate)
Extended-release tablet

5 mEq (540 mg) per tablet

Rx only

100 Tablets

Mission
Pharmacal

PRINCIPAL DISPLAY PANEL - 10 mEq Bottle Label

NDC 0178-0610-01

UROCIT®-K

10 mEq

(Potassium Citrate)
Extended-release tablet

10 mEq (1080 mg) per tablet

Rx only

100 Tablets

Mission
Pharmacal

PRINCIPAL DISPLAY PANEL - 15 mEq Bottle Label

NDC 0178-0615-01

UROCIT®-K

15 mEq

(Potassium Citrate)
Extended-release tablet

15 mEq (1620 mg) per tablet

Rx only

100 Tablets

Mission
Pharmacal