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Thiola Ec Generic Name & Formulations
Legal Class
Rx
General Description
Tiopronin 100mg, 300mg; del-rel tabs.
Pharmacological Class
Reducing agent.
See Also
How Supplied
Tabs—100; EC tabs 100mg—300; 300mg—90
Manufacturer
Generic Availability
Tabs (YES); EC tabs (NO)
Thiola Ec Indications
Indications
In combination with high fluid intake, alkali and diet modification, to prevent cystine stone formation in patients with severe homozygous cystinuria who are not responsive to these measures alone.
Thiola Ec Dosage and Administration
Adult
Give in 3 divided doses at least 1hr before or 2hrs after meals. EC tabs: swallow whole; if difficulty swallowing, it can be crushed and mixed with applesauce. Initially 800mg/day; usual dose 1000mg/day. Measure urinary cystine at 1 month after initiation, and every 3 months thereafter. Adjust dose to maintain urinary cystine levels <250mg/L. Severe toxicity to d-penicillamine: may start with lower dose.
Children
<20kg: not established. ≥20kg: Give in 3 divided doses at least 1hr before or 2hrs after meals. EC tabs: swallow whole; if difficulty swallowing, it can be crushed and mixed with applesauce. Initially 15mg/kg/day. Avoid doses >50mg/kg per day (increased risk of proteinuria). Measure urinary cystine at 1 month after initiation, and every 3 months thereafter. Adjust dose to maintain urinary cystine levels <250mg/L. Severe toxicity to d-penicillamine: may start with lower dose.
Thiola Ec Contraindications
Not Applicable
Thiola Ec Boxed Warnings
Not Applicable
Thiola Ec Warnings/Precautions
Warnings/Precautions
Monitor urinary protein prior to initiation, then every 3 to 6 months during treatment; discontinue if proteinuria occurs. Monitor renal function. Elderly. Pregnancy. Nursing mothers: not recommended.
Thiola Ec Pharmacokinetics
See Literature
Thiola Ec Interactions
Interactions
EC tabs: avoid alcohol 2hrs before and 3hrs after dose.
Thiola Ec Adverse Reactions
Adverse Reactions
Nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, emesis; hypersensitivity reactions, hypogeusia.
Thiola Ec Clinical Trials
See Literature
Thiola Ec Note
Not Applicable
Thiola Ec Patient Counseling
See Literature
