TRACLEER - Film-Coated Tablet Storage and Stability Information

BACKGROUND/GUIDELINES

Shelf Life

The film-coated tablets have a shelf life of 5 years.¹

Stability After Opening of Original Packaging

For the film-coated tablets packed in white high-density polyethylene bottles, use within 30 days after the first opening.¹

Stability of Cut TRACLEER Tablets

The physical and chemical stability of half-cut TRACLEER 62.5 mg tablets were evaluated after 4 weeks of storage at room temperature in a high-density polyethylene plastic bottle. During this time, the bottle was opened and closed 5 times a week to simulate its standard use. Visual inspection and dissolution evaluation revealed no significant changes in the physical and chemical characteristics of the tablet under the conditions tested.²

Stability of Crushed TRACLEER Tablets

A study investigating the stability of crushed TRACLEER 62.5 mg tablets found that the crushed tablets were stable for a period of 6 months when stored below 30°C, 65% relative humidity and protected from light. Furthermore, crushed TRACLEER 62.5 mg tablets diluted 1:1 with lactose were stable for a period of 2 months when stored under similar conditions.³

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 06 November 2024.