Brand Names for Propylthiouracil Tablets
Propylthiouracil is primarily available as a generic medication in the United States, with no widely recognized brand name currently marketed, though historically it has been sold under brand names such as Propycil in some countries.
Available Formulations
Generic propylthiouracil tablets are the standard formulation available in the United States, typically supplied as 50 mg tablets 1
Propycil was a brand name used by Solvay in Germany for 50 mg propylthiouracil tablets, though this may no longer be widely available 1
In Poland, propylthiouracil has been manufactured by Jelfa as 50 mg tablets under the generic name 1
Clinical Context and Safety Considerations
Propylthiouracil carries a black box warning from the FDA (issued in 2009) for severe hepatotoxicity, particularly in children, and should be avoided in pediatric populations 2
The American Association of Clinical Endocrinologists notes that PTU has a higher risk of hepatotoxicity compared to methimazole, especially with prolonged use, requiring close liver function monitoring 3
PTU is specifically indicated for first-trimester pregnancy when treating hyperthyroidism, as it has a lower risk of teratogenicity compared to methimazole during this period 4
Bioequivalence Between Formulations
Studies comparing different propylthiouracil formulations (Jelfa vs. Propycil) demonstrated bioequivalence of 96.8%, with no significant differences in pharmacokinetic parameters between generic and branded products 1
Despite meeting USP specifications, major differences in dissolution rates have been observed among commercially available propylthiouracil products, though these did not translate to clinically significant differences in bioavailability 5
Common Pitfall to Avoid
- Do not assume brand name availability when prescribing propylthiouracil in the United States—prescribe by generic name to ensure availability and avoid pharmacy confusion, as the medication is predominantly dispensed as a generic formulation 1