Full Prescribing Information

INDICATIONS: Urocit^®-K (potassium citrate) extended-release tablets are a prescription medicine used in the management of two common types of kidney stones: calcium oxalate stones and uric acid stones. Urocit-K can also help treat certain metabolic problems (acidosis) caused by kidney disease.

Important Safety Information

Urocit-K is not for everyone. You should not take Urocit-K if you:

• Have high levels of potassium in your blood, or you have any condition that may put you at risk for high blood potassium such as chronic kidney failure, uncontrolled diabetes, severe dehydration (loss of body water), strenuous exercise if you are not used to it, adrenal insufficiency (your adrenal glands do not produce enough of certain chemicals), or you have a condition that causes extensive breakdown of tissues in your body, such as severe burns
• Are taking medicines that can increase potassium levels such as triamterene, spironolactone, or amiloride
• Have trouble swallowing tablets, or have certain conditions that do not allow the tablets to pass through your body, such as delayed emptying of the stomach, or narrowing or blockage of your esophagus or intestines
• Are taking medications known as anticholinergics, which are used to treat stomach cramps, diarrhea, dizziness or motion sickness, or certain urinary disorders
• Have stomach or intestinal ulcers, a urinary tract infection, or kidney disease

Tell your doctor about your medical history, including if you have the following conditions:

• Kidney disease
• Heart problems, such as a heart attack or heart failure
• Are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed

It is important to tell your doctor about all your medical conditions and all medicines that you take. This may reduce the risk of serious side effects. Certain medicines can interact with Urocit-K and irritate your stomach and intestines. If you experience severe vomiting, abdominal pain, black, tarry stools, or other signs of intestinal bleeding, stop taking Urocit-K and see your doctor immediately. Other drugs or medical conditions can increase the levels of potassium in your blood, which can lead to cardiac arrest or death. These serious and potentially fatal reactions can occur rapidly with no noticeable symptoms. Tell your doctor if you are taking certain blood pressure medications such as ACE (angiotensin converting enzyme) inhibitors, ARBs (angiotensin receptor blockers), spironolactone, eplerenone, or aliskiren, or NSAIDs (nonsteroid anti-inflammatory drugs) as these medications can increase potassium levels.

The most common side effects of Urocit-K are abdominal discomfort, vomiting, diarrhea, loose stools, or nausea. Taking each dose with meals or snacks can help reduce these side effects, or you can talk to your doctor about reducing your dose.

These are not all the possible side effects of Urocit-K. Call your doctor for medical advice about side effects. You may report negative side effects to Mission Pharmacal Company at 1-800-298-1087, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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