thiola ec
Pharmaranks rates Thiola Ec 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Thiola Ec (Tiopronin) is a reducing and complexing thiol.
Tiopronin · by Mission Pharmacal
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Tiopronin
- Drug class
- Reducing and Complexing Thiol
- Form
- Tablet, delayed release
- Strength
- Tiopronin 100MG · Tiopronin 300MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Mission Pharmacal
- FDA application
- NDA211843
What is Thiola Ec?
From the FDA label:Tiopronin Delayed-Release Tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure: Tiopronin has the empirical formula C 5 H 9 NO 3 S and a molecular weight of 163.20. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white crystalline powder, which is freely soluble in water. Each Tiopronin Delayed-Release Tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in Tiopronin Delayed-Release Tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate. image
How to use
2.1 Recommended Dosage Adults: The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage was about 1,000 mg/day. Pediatrics: The recommended initial dosage in pediatric patients weighing 20 kg and greater is 15 mg/kg/day. Avoid dosages greater than 50 mg/kg per day in pediatric patients [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]. 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. 2.2 Preparation and Administration Instructions 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. Preparation and Administration of Tiopronin Delayed-Release Tablets Mixed in Applesauce 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…
Side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Proteinuria [see Warnings and Precautions (5.1)] • Hypersensitivity [see Warnings and Precautions (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 BioComp Pharma, Inc. at toll-free phone # 1-866- 762-2365 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of the drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions occurring at an incidence of ≥5% in an uncontrolled trial in 66 patients with cystinuria age 9 to 68 years are shown in the table below. Patients in group 1 had previously been treated with d-penicillamine; those in group 2 had not. Of those patients who had stopped taking d-penicillamine due to toxicity (34 out of 49 patients in group 1), 22 were able to continue treatment with Tiopronin Tablets. In those without prior history of d-penicillamine treatment, 6% developed reactions of sufficient severity to require Tiopronin Tablets withdrawal. Table 1 presents…
Warnings
Important safety information
5.1 Proteinuria 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 [see Dosage and Administration (2.3 ), Adverse Reactions (6.1, 6.2), Use in Specific Populations (8.4)]. Monitor patients for the development of proteinuria and discontinue therapy in patients who develop proteinuria [see Dosage and Administration (2.3)]. 5.2 Hypersensitivity Reactions Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported [see Contraindications (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) 5.1 Proteinuria 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 [see Dosage and Administration (2.3), Adverse Reactions (6.1, 6.2), Use in Specific Populations (8.4)]. Monitor patients for the development of proteinuria and discontinue therapy in patients who develop proteinuria [see Dosage and Administration (2.3)]. 5.2 Hypersensitivity Reactions Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported [see Contraindications (4)].
Who should not take Thiola Ec
Tiopronin Delayed-Release Tablets are contraindicated in patients with hypersensitivity to tiopronin or any other components of Tiopronin Delayed-Release Tablets [see Warnings and Precautions (5.2)]. Hypersensitivity to tiopronin or any component of Tiopronin Delayed-Release Tablets (4)
Overdose — what happens if you take too much
There is no information on overdosage with tiopronin.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 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 [see Clinical Pharmacology (12.3)].
Drug class
Dosage forms
Tablet, delayed release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- How is Thiola Ec rated?
- pharmaranks gives Thiola Ec a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Thiola Ec?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Thiola Ec. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Thiola Ec?
- Thiola Ec is marketed by Mission Pharmacal. You can see Mission Pharmacal's full profile, rating, and other products on pharmaranks.
- Is Thiola Ec a brand-name or generic drug?
- Thiola Ec is a brand-name product with the active ingredient Tiopronin.
- Is Thiola Ec available over the counter?
- No. Thiola Ec is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Thiola Ec come in?
- Thiola Ec is currently marketed as tablet, delayed release, per the FDA's National Drug Code Directory.
- What class of drug is Thiola Ec?
- Thiola Ec is classified as reducing and complexing thiol, per the FDA's Established Pharmacologic Class.
- Is Thiola Ec FDA-registered?
- Thiola Ec is on record with the U.S. FDA under application number NDA211843. You can verify this on its official FDA label.
- Has Thiola Ec been recalled by the FDA?
- Thiola Ec has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Thiola Ec safe?
- There's no single safe-or-not verdict. pharmaranks gives Thiola Ec a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Thiola Ec?
- Thiola Ec's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in greater detail in other sections of the labeling: • Proteinuria [see Warnings and Precautions (5.1)] • Hypersensitivity [see Warnings and Precautions (5.2)] Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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thiola ec
70/100