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
Important Safety Information
Contraindications
- Patients with hyperkalemia, peptic ulcer disease, active urinary tract infection, and renal insufficiency
- Conditions predisposing patients to hyperkalemia, including chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, and extensive tissue breakdown
Warnings and Precautions
- 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
- Gastrointestinal lesions: 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
Patient Counseling Information
Administration of Drug- Patients should be told to take Urocit-K 15 mEq without crushing, chewing, or sucking the tablet
- Patients should be told to take Urocit-K 15 mEq only as directed, especially if the patient is also taking both diuretics and digitalis preparations
- Patients should be told to check with the doctor if they experience difficulty swallowing the tablet or it seems to stick in the throat
- Patients should be told to check with the doctor at once if they notice tarry stools or other signs of gastrointestinal bleeding
- Patients should be advised that regular blood tests and electrocardiograms will be performed to ensure safety
Patient Monitoring Information
Hyperkalemia
- Patients with impaired mechanisms for excreting potassium should be closely monitored for signs of hyperkalemia with periodic blood tests and ECGs
This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.
Please see full Prescribing Information
StoneDisease.org
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