THIOLA EC Delayed-release tablet (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Mission Pharmacal Company

Λέξεις κλειδιά

0178-0901 0178-0902

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1. Indications and Usage

THIOLA EC is 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 ...

2. Dosage and Administration

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 ...

3. Dosage Forms and Strengths

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. ...

4. Contraindications

THIOLA EC is contraindicated in patients with hypersensitivity to tiopronin or any other components of THIOLA EC [see Warnings and Precautions (5.2)].

5. Warnings and Precautions

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 ...

6. Adverse Reactions

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 ...

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 ...

6.2. Postmarketing Experience

Adverse reactions have been reported from the literature, as well as during post-approval use of THIOLA. Because the post-approval reactions are reported voluntarily from a population of uncertain size, ...

7. Drug Interactions

7.1 Alcohol Tiopronin is released faster from THIOLA EC in the presence of alcohol and the risk for adverse events associated with THIOLA EC when taken with alcohol is unknown. Avoid alcohol consumption ...

8.1. Pregnancy

Risk Summary 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 ...

8.2. Lactation

Risk Summary 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. ...

8.4. Pediatric Use

THIOLA EC is indicated in pediatric patients weighing 20 kg or more with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine ...

8.5. 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 ...

10. Overdosage

There is no information on overdosage with tiopronin.

11. Description

THIOLA EC (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 ...

12.1. Mechanism of Action

The goal of therapy is to reduce urinary cystine concentration below its solubility limit. Tiopronin is an active reducing agent which undergoes thiol-disulfide exchange with cystine to form a mixed disulfide ...

12.2. Pharmacodynamics

The decrement in urinary cystine produced by tiopronin is generally proportional to the dose. A reduction in urinary cystine of 250-350 mg/day at tiopronin dosage of 1 g/day, and a decline of approximately ...

12.3. Pharmacokinetics

Absorption THIOLA EC Tablets When THIOLA IR and THIOLA EC single doses were given to fasted healthy subjects, the median time to peak plasma levels (Tmax) was 1 (range: 0.5 to 2.1) and 3 (range: ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term carcinogenicity studies in animals have not been performed. Mutagenesis Tiopronin was not genotoxic in the chromosomal aberration, sister chromatid exchange, and in vivo ...

16.1. How Supplied

100 mg delayed-release, round, white to off-white tablet imprinted with T1 on one side with red ink and blank on the other side: Bottles of 300 NDC 0178-0902-01. 300 mg delayed-release, round, white to ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Administration Instructions For patients who cannot swallow the tablet whole, the THIOLA EC tablets can be crushed and mixed with applesauce. See Dosage and Administration (2.2) for preparation ...