Vardenafil ODT
Overview
The phosphodiesterase – 5 enzyme (PDE-5) is found all over the human body and especially within the penis, pulmonary blood vessels, smooth muscles, and platelets. It is involved in various physiological processes such as smooth muscle contraction and relaxation. PDE-5 has the largest distribution in the penile corpus cavernosum. Since vardenafil is a competitive PDE-5 antagonist, it is able to work similarly to sildenafil and tadalafil to relax muscles and increase blood flow thereby producing an erection in men.1 It also acts on PDE-5 in the pulmonary vasculature causing the blood vessels to relax and widen to decrease mean pulmonary artery pressure.
Vardenafil is commonly administered orally and has no effect in the absence of sexual stimulation.1 The advantage of vardenafil over sildenafil and tadalafil is that it achieves maximum plasma concentration sooner which may result in a faster onset of action. The duration of action of vardenafil oral film-coated tablets is about 4—5 hours, while the duration of action of vardenafil oral disintegrating tablets (ODTs) is 4—6 hours.2, 3 Orally disintegrating tablets of vardenafil produce a higher concentration in the body than the film-coated tablets, meaning that the efficacy may be increased and/or the required dose to achieve an erection may be less when taking vardenafil ODT.3
The incidence of visual disturbances have been reported to a lesser extent in patients taking vardenafil than those taking sildenafil for the treatment of erectile dysfunction.1 Since vardenafil can inhibit PDE5 on esophageal smooth muscle, this can cause reduced esophageal motility and lower esophageal sphincter (LES) tone, which can worsen the symptoms of gastroesophageal reflux disease (GERD).
Indications
Vardenafil is indicated for the treatment of male erectile dysfunction (ED).
How Supplied
Commercially-Available Tadalafil Options
Vardenafil was approved by the FDA in August 2003 for erectile dysfunction. An orally disintegrating tablet was approved by the FDA in June 2010. Today, it is available commercially as an oral tablet in various strengths (2.5 mg, 5 mg, 10 mg, and 20 mg) and as a 10 mg oral disintegrating tablet.
Compounded Vardenafil Options
Since vardenafil is already commercially available as an oral disintegrating tablet and oral tablet, compounded vardenafil oral disintegrating tablets (ODT) are reserved for patients that require a higher or more customizable dosage than what is available commercially and for those that would benefit from an oral disintegrating formulation as determined by a prescriber. The most popular formulation compounded at Galleria Medical Pharmacy is vardenafil 25 mg ODT. An oral disintegrating tablet is similar to a hard tablet taken orally but is designed to quickly disintegrate in the mouth. It may also be placed under the tongue for a potential faster onset of action and to reduce upset stomach sometimes experienced with oral tablets. ODTs are quad-scored and can be broken into smaller dosage forms if necessary.
Storage
Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.
Reference
- Montague DK, Jarow JP, Broderick GA, et al. Chapter 1: The management of erectile dysfunction: an AUA update. J Urol 2005;174:230-9.
- Levitra (vardenafil) package insert. Kenilworth, NJ: Schering-Plough; 2007 Mar.
- Staxyn (vardenafil orally disintegrating tablets) package insert. Whitehouse Station, NJ: Schering-Plough; 2010 Jun.
Compounding Pharmacy Statement
Vardenafil ODTs are compounded with drug components whose suppliers are registered with the FDA. While Galleria Medical Pharmacy adheres to USP <795> guidelines and applicable state and federal regulations to meet the required quality standards, the statements made regarding compounded vardenafil ODTs have not been evaluated by the FDA for safety or clinical effectiveness. As such, this preparation is not intended to diagnose, treat, cure, or prevent any disease. For inquiries concerning this preparation, please contact (504) 267-9876.
