Generic tiopronin delayed-release tablets
100 mg and 300 mg

What are tiopronin delayed-released tablets?

Generic tiopronin delayed-release tablets are 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 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Generic tiopronin delayed-release tablets must be taken without food.1

Resources

References

  1. Generic tiopronin delayed-release tablets. Prescribing Information. Torrent Pharma Inc.

View

Indication and Important Safety Information

INDICATION

Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for prevention of cystine stone formation in adult and pediatric patients 9 years of age and older with severe homozygous cystinuria who are not responsive to these measures alone.

WARNINGS AND PRECAUTIONS

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.

Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.

DRUG INTERACTIONS

Alcohol: Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking tiopronin delayed-release tablets.

USE IN SPECIFIC POPULATIONS:

  • Pregnancy: Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes. Tell your healthcare provider immediately if you become pregnant or planning to become pregnant.
  • Lactation: There are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child. A published study suggests that tiopronin may suppress milk production. Because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with tiopronin delayed-release tablets. Tell your healthcare provider immediately if you plan on breast feeding.
  • Pediatric Use: Tiopronin delayed-release tablets are indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation who are not responsive to these measures alone.
  • Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets.

  • Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

For more detailed information, please refer to the full Prescribing Information at: www.tiopronin.us/PI

If you get any side effects, talk to your healthcare provider. This includes possible side effects not listed in this material. You may also report side effects directly by calling Torrent Pharma Inc. at: 1-800-912-9561 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

This material is for education purposes only. It is not intended to be, and should not be used as, a substitute for medical advice.