Vardenafil / Apomorphine HCl Troche

Vardenafil

Vardenafil belongs to the phosphodiesterase type 5 (PDE5) inhibitors drug class, a class of drugs commonly indicated for treatment of erectile dysfunction (ED). It is a selective phosphodiesterase (PDE) type 5 inhibitor similar to sildenafil and tadalafil. This class of drugs does not inhibit prostaglandins as do some agents for treating ED (e.g., alprostadil). Vardenafil and tadalafil are more selective for PDE5 than PDE6, which is present in the retina. This leads to less visual adverse effects such as those reported in sildenafil-treated patients. The advantage of vardenafil may be that it achieves maximum plasma concentration sooner than sildenafil and tadalafil which may result in a faster onset of action. In an analysis of 580 patients, erections improved in 80% of men, and the ability to complete sexual intercourse with ejaculation was increased. Efficacy in treating diabetics and radical prostectomy patients has also been demonstrated. According to ED treatment guidelines, oral phosphodiesterase type 5 inhibitors (PDE5 inhibitor) are considered first-line therapy. Vardenafil was approved by the FDA in August 2003 for erectile dysfunction. An orally disintegrating tablet was approved by the FDA in June 2010.

Apomorphine HCl

Apomorphine, a non-narcotic derivative of morphine, is approved as a sublingual film for the treatment of acute, intermittent ‘off’ episodes associated with Parkinson’s disease and as a subcutaneous injection for use in patients with advanced Parkinson’s disease. Apomorphine has also been used as a diagnostic test for dopaminergic responsiveness in parkinsonian syndromes to determine whether a patient will respond or is still responsive to levodopa therapy. Apomorphine has a quick onset of action, a significant effect on parkinsonian hypomobility (‘off’ episodes) unresponsive to oral medications, and a therapeutic effect comparable to levodopa. Due to a high incidence of nausea and vomiting, apomorphine is coadministered with the antiemetic drug trimethobenzamide. Based on reports of profound low blood pressure and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of 5-HT3 antagonists with apomorphine is contraindicated. Similar to other dopamine agonists, apomorphine has been associated with sudden sleep onset during activities of daily living and impulse control symptoms (e.g., intense urges to gamble or spend money, increased sexual urges). During treatment with apomorphine, practitioners should monitor for hypotension, orthostasis, new or worsening impulse control symptoms, and patient reports of sudden sleep onset.