Tadalafil / Tramadol HCl Troche (Each)

Tadalafil
Like sildenafil and vardenafil, tadalafil is a selective phosphodiesterase (PDE) type 5 inhibitor. Treatment of male erectile dysfunction (ED), pulmonary arterial hypertension (PAH), benign prostatic hypertrophy (BPH), or the simultaneous management of erectile dysfunction and BPH calls for oral administration. Unlike several medications used for impotence (e.g., alprostadil), tadalafil does not block prostaglandins. Unlike sildenafil, tadalafil—which is more selective for PDE5 than for PDE6 found in the retina—has not been linked to visual abnormalities. Since PDE inhibitors encourage erections only in response of sexual activity, the longer duration of action of tadalafil lets more spontaneity in sexual activity. Oral phosphodiesterase type 5 inhibitors (PDE5 inhibitor) top ED treatment guidelines’ firstline treatment Tadalafil was undergoing phase II studies to treat female sexual dysfunction, but more research was stopped. November 2003 saw FDA clearance for once daily usage without respect to timing of sexual activity was approved in January 2008 for treatment of male erectile dysfunction (ED). In May 2009, the FDA approved tadalafil (Adcirca) for the therapy of pulmonary arterial hypertension (PAH). Patients with pulmonary arterial hypertension (PAH) in clinical trials treated with tadalafil showed increased exercise capacity and less clinical deterioration than those receiving placebo.

Hydrochloride Tramadol
Indicated for the management of pain strong enough to call for an opioid pain reliever and for which alternative therapies are available, tramadol is an oral opioid agonist. Insufficient. Tramadol inhibits norepinephrine and serotonin reuptake in addition to attaching to muopioid receptors. The analgesic impact of tramadol is thought to be Tramadol showed same efficacy to aspirin with codeine, acetaminophen with codeine, both binding muopioid receptors and poor reuptake of norepinephrine and serotonin inhibiting. Acetaminophen with oxycodone, and codeine when investigated in three long-term controlled trials in patients with many different chronic painful conditions, is conditionally suggested. For treatment of hand, knee, or hip osteoarthritis in patients who might have contraindications to NSAIDs, seek other treatments inadequate, or lack of surgical alternatives.

Tadalafil:

• PDE5 enzyme inhibition

• Increases cGMP in smooth muscle cells

• Leads to vasodilation and improved penile blood flow

• Helps achieve and maintain erection

Tramadol HCl:

• µ-opioid receptor agonist (weak)

• Inhibits serotonin and norepinephrine reuptake

• Modulates pain pathways and delays ejaculation via central nervous system action

Combination therapy targets both physical (ED) and psychogenic/neurological (PE or associated anxiety/pain) aspects of sexual dysfunction.

Contraindications:

• Nitrate-containing drugs (e.g., nitroglycerin) – risk of severe hypotension
• Known hypersensitivity to tadalafil or tramadol
• Severe hepatic or renal impairment
• Respiratory depression or severe asthma (due to tramadol)
• History of seizures or epilepsy
• Precautions:
• Cardiovascular disease (MI, stroke, arrhythmias)
• Risk of abuse, dependence, or addiction (due to tramadol)
• Serotonin syndrome risk when combined with SSRIs/SNRIs
• Use in elderly: increased sensitivity to hypotension, dizziness
• Caution with alcohol or other CNS depressants

Tadalafil-Related:

• Headache
• Flushing
• Dyspepsia
• Nasal congestion
• Back/muscle pain
• Rare: priapism, vision/hearing loss

Tramadol-Related:

• Dizziness, drowsiness
• Nausea, vomiting, constipation
• Dry mouth
• Sweating
• Serotonin syndrome (if used with serotonergic drugs)
• Risk of dependence or withdrawal

Troche-Specific Effects:

• Mild oral irritation, tingling, or numbness at site of administration
• Bitter aftertaste (in some patients)

Pregnancy:

• Tadalafil: Not intended for women; insufficient data in pregnant women

• Tramadol: Category C; crosses placenta and may cause neonatal withdrawal or respiratory depression

• Not recommended during pregnancy unless benefit outweighs risk

Breastfeeding:

• Tramadol is excreted in breast milk; may cause serious adverse effects in infants (e.g., respiratory depression, sedation)

• Tadalafil’s excretion in milk is unknown, but use not advised

• Avoid use during breastfeeding

Store this medication in its original container 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.

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