Tiopronin
Tiopronin Prescribing Information
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.
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.
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.
For patients who can swallow semi-solid food, Tiopronin Delayed-Release Tablets can be crushed and mixed
with applesauce:
1. Crush the Tiopronin Delayed-Release Tablet in a clean pill crusher or mortar and pestle. Always crush one tablet at a time.
2. Measure approximately one tablespoon of applesauce and transfer it into a container with the crushed Tiopronin Delayed-Release Tablet.
3. Mix the crushed Tiopronin Delayed-Release Tablet in the applesauce until the powder is well dispersed.
4. Administer the entire Tiopronin Delayed-Release Tablets-applesauce mixture to the patient’s mouth immediately. (However, if this is not possible, the mixture can be stored in a refrigerator for up to 2 hours after adding the crushed tablet to the applesauce. Discard any mixture that has not been given within 2 hours.)
5. To assure that any leftover applesauce mixture from the container is recovered, add tap water to the same
container, mix, and have the patient drink the water.
Measure urinary cystine 1 month after starting Tiopronin Delayed-Release Tablets and every 3 months thereafter. Adjust Tiopronin Delayed-Release Tablets dosage to maintain urinary cystine concentration less than 250 mg/L.
Assess for proteinuria before treatment and every 3 to 6 months during treatment
Discontinue Tiopronin Delayed-Release Tablets in patients who develop proteinuria, and monitor urinary protein and renal function. Consider restarting Tiopronin Delayed-Release Tablets treatment at a lower dosage after resolution of proteinuria.
Tablets for oral use:
100 mg tablets: round, white to off-white and imprinted in red with “T1” on one side
300 mg tablets: round, white to off-white and imprinted in red with “T3” on one side
- Lactation: Breastfeeding is not recommended. (8.2)
- Geriatric: Choose dose carefully and monitor renal function in the elderly. (8.5)
Tiopronin Delayed-Release Tablets are contraindicated in patients with hypersensitivity to tiopronin or any other components of Tiopronin Delayed-Release Tablets
Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin
use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for
proteinuria
(8.4)]. Monitor patients for the development of proteinuria and discontinue therapy in patients who develop
proteinuria
Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported
Contraindications (4)].