Maximum-strength, more convenient option available to help increase patient compliance
SAN ANTONIO, TX (February 17, 2010) – Mission Pharmacal Company announced today the introduction of the Urocit®-K 15 mEq extended-release tablet. The new formulation builds on the heritage of Urocit-K with a maximum-strength alkalinizing agent to help prevent kidney stone recurrence in more than 90 percent of patients.
"The availability of Urocit-K 15 mEq is important for kidney stone patients because it can help ease their pill burden," said David S. Goldfarb, M.D., clinical chief of nephrology at New York University Langone Medical Center and at New York Harbor Veterans Affairs Medical Center. "Therefore, this new dosage regimen may help patients to comply with their treatment regimens and, ultimately, help keep new kidney stones from forming."
Approximately one in 10 people will have a kidney stone at some point in their lives. Once a person develops a stone, he or she is more likely to develop additional stones. Urocit-K 15 mEq offers these kidney stone sufferers the only twice-daily treatment at this dosage strength. The new formulation also provides patients with 50 percent more of the active ingredient, potassium citrate, than Urocit-K 10 mEq (1080 mg) potassium citrate.
Potassium citrate helps patients maintain targeted urinary citrate and urinary pH levels, which helps reduce kidney stone formation. Urocit-K 15 mEq also features a slow-release wax-matrix delivery system that enhances a patient’s tolerability to take oral potassium citrate, which in turn, also helps increase patient compliance.
"Urocit-K is considered the standard of care for kidney stone patients, and we are excited to provide a new, enhanced option for the millions of Americans with kidney stones," said Neill Walsdorf, Jr., president of Mission Pharmacal. "Continuing to improve patient care is our longstanding tradition at Mission, and we look forward to helping those suffering from kidney stones with this new Urocit-K product."
Mission Pharmacal continues to invest in research and development to improve treatment outcomes of nephrolithiasis (kidney stones) for physicians and patients. For more product information on Urocit-K 15 mEq, please visit www.urocit-k.com. For more information on stone disease, please visit stonedisease.org.
About Kidney Stones
Kidney stones, or renal calculi, are aggregates of crystals enclosed in a matrix that develop within the kidneys. They are classified according to the specific types of crystals they contain and fall into five major categories – calcium oxalate, the most common, calcium phosphate, struvite, uric acid and cystine. Depending on the type and size of the stone, healthcare providers may recommend kidney stones be treated with lifestyle changes, medical therapy or, in some cases, surgery.
Each year, more than half a million people go to emergency rooms for kidney stone-related problems. Additionally, it is thought that one in 10 people will have a kidney stone at some time in their lives.
About Urocit®-K
Urocit-K is a slow release formulation of potassium citrate for treatment of kidney stones (nephrolithiasis) in patients with renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate stones of any etiology and uric acid lithiasis, with and without uric acid stones. Urocit-K corrects the pH of the urine and elevates a naturally occurring urinary inhibitor of calcium stone formation (citrate). In addition, Urocit-K lowers saturation of calcium oxalate. This helps control the formation of new stones. For more product information, visit www.urocit-k.com. For more information on stone disease, visit www.stonedisease.org.
About Mission Pharmacal
Mission Pharmacal is a privately held pharmaceutical company based in San Antonio, Texas. For more than 60 years, the company has led the way in providing innovative therapies with the power to manage stone disease across a wide range of kidney stone patients. Currently, Mission Pharmacal provides physicians and consumers with pharmaceutical and nutritional products. For more information, visit www.missionpharmacal.com.
Media Contact:
Ami Shah
Cohn&Wolfe
(212) 798-9773
ami.shah@cohnwolfe.com
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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