Thiola EC Tablets
Generic name:tiopronin
Dosage form: tablet, delayed release
Drug class:Miscellaneous genitourinary tract agents
Medically reviewed by Drugs.com. Last updated on Mar 1, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- How Supplied/Storage and Handling
- Patient Counseling Information
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.
2 DOSAGE AND ADMINISTRATION
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 each day, with or without food. Maintain a routine pattern with regard to meals.
Consider starting THIOLA EC at a lower dosage in patients with history of severe toxicity to d-penicillamine.
Preparation and Administration Instructions
For patients who cannot swallow the tablet whole, THIOLA EC can be crushed and mixed with applesauce. Administration of THIOLA EC with other liquids or foods has not been studied and is not recommended.
Preparation and Administration of THIOLA EC Mixed in Applesauce
For patients who can swallow semi-solid food, THIOLA EC can be crushed and mixed with applesauce:
- Crush the..
