Tadalafil / Tramadol HCl Troche

Overview of Tadalafil / Tramadol HCl Troche

Dosage Strength

Tadalafil / Tramadol 20/30 mg

General Information

Tadalafil, like sildenafil and vardenafil, is a selective phosphodiesterase (PDE) type 5 inhibitor. It is used orally and is used to treat male erectile dysfunction (ED), pulmonary arterial hypertension (PAH), benign prostatic hypertrophy (BPH), or both erectile dysfunction and BPH. Tadalafil does not suppress prostaglandins like certain impotence medications (e.g., alprostadil). Visual problems have not been recorded with tadalafil, which is more selective for PDE5 than PDE6 in the retina, unlike sildenafil. Tadalafil appears to have a longer duration of action (up to 36 hours) than sildenafil and vardenafil for the treatment of ED. Because PDE inhibitors only enhance erections in the presence of sexual stimulation, tadalafil’s longer duration of action allows for greater spontaneity in sexual engagement. Oral phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are regarded first-line medication in ED treatment guidelines. 1 Tadalafil was in phase II studies for the treatment of female sexual dysfunction, but further research was halted. In November 2003, the FDA approved it for the treatment of male erectile dysfunction (ED), then in January 2008, it was approved for once-daily usage without respect to sexual activity timing. Tadalafil (Adcirca) was approved by the FDA in May 2009 for the treatment of pulmonary arterial hypertension (PAH). Tadalafil-treated participants in clinical studies with pulmonary arterial hypertension (PAH) had greater exercise capacity and less clinical deterioration compared to placebo. Tadalafil was approved by the FDA in October 2011 for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) as well as the combined treatment of erectile dysfunction and BPH.

Tramadol HCl
Tramadol is an opioid agonist that is taken orally and is used to relieve pain that is severe enough to warrant an opioid analgesic and for which other therapies are ineffective. Tramadol, in addition to binding to mu-opioid receptors, inhibits norepinephrine and serotonin reuptake. Tramadol’s analgesic effect is thought to be related to both binding mu-opioid receptors and mild suppression of norepinephrine and serotonin reuptake. Tramadol was found to be as effective as acetaminophen with codeine, aspirin with codeine, and acetaminophen with oxycodone in three long-term controlled trials in patients suffering from a variety of chronic pain problems. 2 Tramadol is conditionally suggested for the treatment of hand, knee, or hip osteoarthritis in individuals who are contraindicated to NSAIDs, find other therapy inadequate, or have no surgical options. 3

Seizures have been documented in patients using tramadol within the authorized dosage range; the risk of seizures increases with tramadol doses over the recommended range. Seizure risk may also rise in people with a seizure disorder, a history of seizures, a recognized seizure risk, or concurrent use of other medicines that lower the seizure threshold. Naloxone administration may increase the risk of seizures in tramadol overdose. Suicidal ideation has been linked to tramadol, potentially causally. Tramadol should not be prescribed to patients who have suicidal ideation or are addicted; instead, non-narcotic analgesics should be considered in suicidal or depressed patients.2

Tramadol’s safety and efficacy in pediatric patients have not been established. Tramadol is not recommended for children under the age of 12 or for postoperative pain treatment in pediatric patients under the age of 18 following a tonsillectomy and/or adenoidectomy. 24 Ultra-rapid metabolizers of CYP2D6 substrates may convert tramadol to its active metabolite, O-desmethyltramadol, faster and more fully than usual, resulting in greater than normal opioid blood concentrations that might cause deadly respiratory failure. Because some children who are typical metabolizers can covert opioids at rates comparable to ultra-rapid metabolizers, this is a problem for all pediatric patients. 5


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