Thiola Tablets

Generic name:tiopronin
Dosage form: tablet, sugar coated
Drug class:Miscellaneous genitourinary tract agents

Medically reviewed by Drugs.com. Last updated on May 23, 2022.

Indications and Usage for Thiola Tablets

THIOLA 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 Tablets 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 in 3 divided doses at the same times each day at least one hour before or 2 hours after meals.

Consider starting THIOLA at a lower dosage in patients with history of severe toxicity to d-penicillamine.

Monitoring

Measure urinary cystine 1 month after starting THIOLA and every 3 months thereafter. Adjust THIOLA dosage to maintain urinary cystine concentration less than 250 mg/L.

Assess for proteinuria before treatment and every 3 to 6 months during treatment [see Warnings and Precautions (5.1)].

Discontinue THIOLA in patients who develop proteinuria, and monitor urinary protein and renal function. Consider restarting THIOLA treatment at a lower dosage after resolution of proteinuria.