Thiola EC 100 mg/1
tiopronin · TABLET, DELAYED RELEASE · Mission Pharmacal Company
Thiola EC is a tablet, delayed release containing tiopronin at 100 mg/1, taken oral. Manufactured by Mission Pharmacal Company.
Key Facts
- Brand Name
- Thiola EC
- Generic Name
- tiopronin
- NDC Code (Product)
0178-0902- Manufacturer
- Mission Pharmacal Company
- Strength
- 100 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA211843
- Drug Class
- Reducing and Complexing Thiol [EPC]
- Marketing Start
- 06/28/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE THIOLA EC is 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. THIOLA EC is 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 The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage was about 1,000 mg/day. ( 2.1 ) The recommended initial dosage in pediatric patients 20 kg and greater is 15 mg/kg/day. Avoid dosages greater than 50 mg/kg per day in pediatric patients. ( 5.1 , 8.4 ) Measure urinary cystine 1 month after initiation of THIOLA EC and every 3 months thereafter ( 2.3 ) Administer THIOLA EC in 3 divided doses at the same times each day, with or without food. Maintain a routine pattern with regard to meals. ( 2.1 ) THIOLA EC can be crushed and mixed with applesauce. For preparation and administration instructions, see the full prescribing information. ( 2.2 ) 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 THIOLA EC in 3 divided doses at the same times e…
Contraindications
4 CONTRAINDICATIONS THIOLA EC is contraindicated in patients with hypersensitivity to tiopronin or any other components of THIOLA EC [see Warnings and Precautions ( 5.2 )] . Hypersensitivity to tiopronin or any component of THIOLA EC ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Alcohol Tiopronin is released faster from THIOLA EC in the presence of alcohol and the risk for adverse events associated with THIOLA EC when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking THIOLA EC [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 Mission Pharmacal Company at toll-free phone # 1-800-298-1087 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…
Frequently Asked Questions
What is Thiola EC used for?
Thiola EC contains tiopronin. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.
Is Thiola EC a controlled substance?
Thiola EC is not classified as a controlled substance by the DEA.
What is the generic name for Thiola EC?
The generic name for Thiola EC is tiopronin. There are 10 other brand versions of tiopronin.
What is the NDC code for Thiola EC 100 mg/1?
The NDC (National Drug Code) for Thiola EC 100 mg/1 is 0178-0902, listed by Mission Pharmacal Company.