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)

• 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)

Tablets: 100 mg and 300 mg (3)

• Hypersensitivity to tiopronin or any component of THIOLA EC (4)

• Proteinuria, including nephrotic syndrome, and membranous nephropathy, has been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. (2.1, 5.1, 8.4)
• Hypersensitivity reactions have been reported during tiopronin treatment. (4, 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.

• Lactation: Breastfeeding is not recommended. (8.2)
• Geriatric: Choose dose carefully and monitor renal function in the elderly. (8.5)