Dosing instructions
Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). The objective of treatment with Urocit®-K is to provide Urocit®-K in sufficient dosage 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 or 7.0.
Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine or a significant fall in blood hemocrit or hemoglobin.
Severe hypocitraturia
In patients with severe hypocitraturia (urinary citrate < 150 mg/day), therapy should be initiated at a dosage of 60 mEq /day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months. Doses of Urocit®-K greater than 100 mEq/day have not been studied and should be avoided.
Mild to moderate hypocitraturia
In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. Doses of Urocit®-K greater than 100 mEq/day have not been studied and should be avoided.
Urocit®-K is a prescription form of potassium citrate. It helps restore the chemicals in urine that stop crystals from forming, and reduces the formation of the two most common types of kidney stones: calcium oxalate and uric acid stones.
Important Safety Information
Urocit®-K is not for everyone. It has not been tested on children, pregnant women, or women who are breastfeeding, and it is unknown whether Urocit®-K can affect reproductive capacity, unborn children, or breast milk content. You should not take Urocit®-K if you are pregnant, may become pregnant, or are currently breastfeeding, unless your doctor has discussed the risks with you and determined that it is necessary.
Certain drugs can interact with Urocit®-K and lead to increased gastrointestinal (GI) irritation. Drug interactions can also lead to hyperkalemia, an excess of potassium in your blood that could lead to cardiac arrest or death. These serious and possibly fatal conditions can develop rapidly with no noticeable symptoms. Always talk to your doctor about any medications you are taking before starting a prescription of Urocit®-K.
If you have hyperkalemia, or any condition that puts you at risk for the condition or prevents your body from processing potassium normally, do not take Urocit®-K because it could lead to cardiac arrest. Conditions that may put you at risk include kidney failure, uncontrolled diabetes, severe dehydration, strenuous physical exercise if you're unconditioned, extensive tissue breakdown, or adrenal insufficiency (when your adrenal glands do not produce the correct amount of chemicals needed to regulate the function of your organs).
Do not take Urocit®-K if you have an active urinary tract infection, peptic ulcer disease, or conditions that slow or prevent the tablet from passing through your GI tract, such as compression of the esophagus, delayed gastric emptying, or narrowing or blockage of your intestines.
Take Urocit®-K only as directed. Do not crush, chew, or suck on the tablets, and check with your doctor if you experience any trouble swallowing tablets or if they seem to get stuck in your throat.
To ensure your safety during your prescription, your doctor may perform regular blood tests and EKGs (which analyze the electrical activity in your heart).
Some patients taking Urocit®-K may develop minor GI side effects such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. To reduce these effects, take each dose of Urocit®-K with meals or snacks, or talk to your doctor about reducing the amount of your dosage.
If you experience severe vomiting, abdominal pain, tarry stools, or other signs of intestinal bleeding, stop taking Urocit®-K and see your doctor right away. These could be signs of a serious condition such as a perforated or blocked bowel.
To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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