HHIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use THIOLA® EC safely and effectively.
See full prescribing information for THIOLA EC.
THIOLA EC(tiopronin)delayed-release tablets, for oral use
Initial U.S. Approval: 1988
INDICATIONS AND USAGE
THIOLA EC is a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and dietmodification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greaterwith severe homozygous cystinuria, who are not responsive to these measures alone. (1)
DOSAGE AND ADMINISTRATION
• The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage wasabout 1,000 mg/day. (2.1)
• The recommended initial dosage in pediatric patients 20 kg and greater is 15 mg/kg/day. Avoid dosages greaterthan 50 mg/kg per day in pediatric patients. (2.1, 5.1, 8.4)
• Administer THIOLA EC in 3 divided doses at the same times each day, with or without food. Maintain a routinepattern with regard to meals. (2.1)
• Swallow THIOLA EC tablets whole. (2.1)
• Measure urinary cystine 1 month after initiation of THIOLA EC and every 3 months thereafter. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg and 300 mg (3)
CONTRAINDICATIONS
• Hypersensitivity to tiopronin or any component of THIOLA EC (4)
WARNINGS AND PRECAUTIONS
• 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)
ADVERSE REACTIONS
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.
USE IN SPECIFIC POPULATIONS
• Lactation: Breastfeeding is not recommended. (8.2)
• Geriatric: Choose dose carefully and monitor renal function in the elderly. (8.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 06/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Monitoring
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Proteinuria
5.2 Hypersensitivity Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Alcohol
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
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