Salute e Benessere
Endo Launches Tiopronin Delayed-Release Tablets, Generic Version of THIOLA EC®
The medication is used in combination with high fluid intake, alkali (low acid), and dietary changes to help prevent the formation of one type (cystine) of kidney stones in certain adult and pediatric patients.
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THIOLA EC is a registered trademark of Mission Pharmacal Company.
Tiopronin delayed-release tablets are contradicted in patients with hypersensitivity to tiopronin or any other components of tiopronin delayed-release tablets.
Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. Monitor patients for the development of proteinuria and discontinue therapy in patients who develop proteinuria.
Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported.
Most common adverse reactions (≥ 10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.
Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking tiopronin delayed-release tablets.
Lactation: Breastfeeding is not recommended during treatment with tiopronin delayed-release tablets.
Pediatric Use: Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg.
Geriatric Use: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.
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This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to Endo's product launch, quality, affordability, efficacy, reliability or sales. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, changes in competitive, market or regulatory conditions, and consumer and physician acceptance of current and new products. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.
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