TIOPRONIN 100 mg/1
tiopronin · TABLET, DELAYED RELEASE · Torrent Pharmaceuticals Limited
TIOPRONIN is a tablet, delayed release containing tiopronin at 100 mg/1, taken oral. Manufactured by Torrent Pharmaceuticals Limited.
Key Facts
- Brand Name
- TIOPRONIN
- Generic Name
- tiopronin
- NDC Code (Product)
13668-691- Manufacturer
- Torrent Pharmaceuticals Limited
- Strength
- 100 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216990
- Drug Class
- Reducing and Complexing Thiol [EPC]
- Marketing Start
- 01/30/2024
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. Tiopronin Delayed-Release Tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage Adults: The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage was about 1,000 mg/day. Pediatrics: The recommended initial dosage in pediatric patients weighing 20 kg and greater is 15 mg/kg/day. Avoid dosages greater than 50 mg/kg per day in pediatric patients [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]. Administer Tiopronin Delayed-Release Tablets in 3 divided doses at the same times each day, with or without food. Maintain a routine pattern with regard to meals. Consider starting Tiopronin Delayed-Release Tablets at a lower dosage in patients with history of severe toxicity to d-penicillamine. 2.2 Preparation and Administration Instructions For patients who cannot swallow the tablet whole, Tiopronin Delayed-Release Tablets can be crushed and mixed with applesauce. Administration of Tiopronin Delayed-Release Tablets with other liquids or foods has not been studied and is not recommended. Preparation and Administration of Tiopronin Delayed-Release Tablets Mixed in Applesauce For patients who can swallow semi-solid food, Tiopronin Delayed-Release Tablets c…
Contraindications
4 CONTRAINDICATIONS Tiopronin Delayed-Release Tablets are contraindicated in patients with hypersensitivity to tiopronin or any other components of Tiopronin Delayed-Release Tablets [see Warnings and Precautions (5.2)]. Hypersensitivity to tiopronin or any component of Tiopronin Delayed-Release Tablets (4)
Drug Interactions
7 DRUG INTERACTIONS 7.1 Alcohol 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 [see Clinical Pharmacology (12.3)].
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Proteinuria [see Warnings and Precautions (5.1)] • Hypersensitivity [see Warnings and Precautions (5.2)] Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis. (6) To report SUSPECTED ADVERSE REACTIONS, contact BioComp Pharma, Inc. at toll-free phone # 1-866- 762-2365 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of the drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions occurring at an incidence of ≥5% in an uncontrolled trial in 66 patients with cystinuria age 9 to 68 years are shown in the table below. Patients in group 1 had previously been treated with d-penicillamine; those in group 2 had not. Of those patients who had stopped taking d-penicillamine due to toxicity (34 out of 49 patients in group 1), 22 were …
Frequently Asked Questions
What is TIOPRONIN used for?
TIOPRONIN contains tiopronin. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.
Is TIOPRONIN a controlled substance?
TIOPRONIN is not classified as a controlled substance by the DEA.
What is the generic name for TIOPRONIN?
The generic name for TIOPRONIN is tiopronin. There are 8 other brand versions of tiopronin.
What is the NDC code for TIOPRONIN 100 mg/1?
The NDC (National Drug Code) for TIOPRONIN 100 mg/1 is 13668-691, listed by Torrent Pharmaceuticals Limited.