Vardenafil (Levitra/Staxyn) Storage, Stability & Shelf Life

Handling: what the labeling says about the two forms

Vardenafil is a PDE5 inhibitor for erectile dysfunction, available as generic film-coated tablets (2.5, 5, 10 and 20 mg) and as a 10 mg orally disintegrating tablet [7][1]. The label says the film-coated tablet is taken orally about 60 minutes before sexual activity, no more than once a day, with or without food [2]. For the disintegrating tablet, the label says to place it on the tongue, let it disintegrate and take it without liquid, immediately after removing it from the blister, also with a maximum of one tablet a day [1].

The label says the disintegrating tablet is not interchangeable with the 10 mg film-coated tablet because it gives higher systemic exposure [1]. In healthy volunteers, Cmax was 15% higher and AUC 44% higher [1].

Which vardenafil is actually in the bottle

Drugs@FDA lists all four Levitra strengths and Staxyn as discontinued, with an FDA determination that this was not for safety or effectiveness reasons, so the prescription products are generics [3][4][7].

Shelf life and the expiration date

No vardenafil-specific data on potency past the expiration date were found.

Compounded vardenafil

Compounded vardenafil is not an FDA-approved drug, and FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients [5].