Tadalafil / Tramadol HCl Troche

Overview of Tadalafil / Tramadol HCl Troche

Dosage Strength

Tadalafil / Tramadol 20/30 mg

General Information

Tadalafil
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

References

1.Montague DK, Jarow JP, Broderick GA, et al. Chapter 1: The management of erectile dysfunction: an AUA update. J Urol 2005;174:230-9.
2.Ultram (tramadol immediate-release tablets) package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2021 Mar.
3.Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res 2020;72:149-162.
4.FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed April 20, 2017.
5.Food and Drug Administration (FDA) Drug Safety Communication: FDA evaluating the risks of using the pain medicine tramadol in children aged 17 years and younger. Retrieved September 21, 2015. Available on the World Wide Web http://www.fda.gov/Drugs/DrugSafety/ucm462991.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
6.Cialis (tadalafil) package insert. Indianapolis, IN: Lilly ICOS, LLC; 2011 Oct.
7.Adcirca (tadalafil) package insert. Indianapolis, IN: Lilly ICOS, LLC; 2011 Apr.
8.Poulsen L, Arendt-Nielsen L, Brosen K, et al. The hypoalgesic effect of tramadol in relation to CYP2D6. Clin Pharmacol Ther 1996;60:636-44.
9.Tramadol hydrochloride extended-release tablets package insert. Morgantown, WV: Mylan Pharmaceuticals, Inc.; 2020 Jul.
10.Tramadol extended-release tablets package insert. Chestnut Ridge, NY: Par Pharmaceutical; 2019 Oct.
11.Tramadol HCl extended-release capsules package insert. Mississauga, ON, Canada; Cipher Pharmaceuticals; 2010 May.
12.Burnett AL, Bivalacqua TJ. Priapism: current principles and practice. Urol Clin N Am 2007;34:631-642.
13.Bortolotti M, Mari C, Giovannini M, et al. Effects of sildenafil on esophageal motility of normal subjects. Dig Dis Sci 2001;46:2301-2306.
14.Conzip (tramadol hydrochloride extended-release capsules) package insert. Bridgewater, NJ: Vertical Pharmaceuticals Inc.; 2021 Mar.
15.Ultram (tramadol immediate-release tablets) package insert. Titusville, NJ: Janssen
16.Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes. http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm Retrieved March 23, 2016
17.Jick H, Derby LE, Vasilakis C, et al. The risk of seizures associated with tramadol. Pharmacotherapy 1998;18:607-11.
18.Kahn LH, Alderfer RJ, Graham DJ. Seizures reported with tramadol. JAMA 1997;278:1661.
19.Ripple MG, Pestaner JP, Levine BS, et al. Lethal combination of tramadol and multiple drugs affecting serotonin. Am J Forensic Med Pathol 2000;21:370-374.
20.Orliaguet G, Hamza J, Couloigner V. A case of respiratory depression in a child with ultrarapid CYP2D6 metabolism after tramadol. Pediatr 2015;135:e753-e755.
21.Rybix ODT (tramadol) package insert. San Diego, CA: Victory Pharma, Inc.; 2009 Dec.
22.Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10(2):113-30.
23.Silberstein SD. Drug-induced headache. Neuro Clinic N America 1998;16:107-23.
24.Qdolo (tramadol HCl) oral solution. Athens, GA: Athena Bioscience, LLC; 2020 Sep.
25.Kadian (morphine sulfate extended-release capsules) package insert. Madison, NJ: Allergan USA, Inc.; 2021 Mar.
26.Morphine sulfate oral solution package insert. Berkley, NJ: Hikma Pharmaceuticals USA, Inc.; 2021 Jun.
27.Avinza (morphine sulfate extended-release capsules) package insert. Gainesville, GA: Alkermes Gainesville LLC.; 2014 Apr.
28.US Food and Drug Administration (FDA). FDA News Release: FDA announces safety and labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics. Retrieved September 11, 2013. Available on the World Wide Web at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367726.htm
29.The American College of Obstetricians and Gynecologists. ACOG Committee Opinion. Opioid use and opioid use disorder during pregnancy. Number 711. August 2017, reaffirmed 2019. Available on the world wide web at https://www.acog.org/-/media/Committee-Opinions/Committee-on-Obstetric-Practice/co711.pdf?dmc=1&ts=20191217T2114577949. Accessed December 16, 2019.
30.Mills, JR, Huizinga MM, Robinson SB, et al. Opioid-Prescribing Guidelines for Uncomplicated Normal Spontaneous Vaginal Birth. Obstetrics and Gynecology 2019;133:81-90.
31.American Academy of Pediatrics (AAP) Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001;108(3):776-789.
32.Ilett KF, Paech MJ, Page-Sharp M et al. Use of a sparse sampling study design to assess transfer of tramadol and its o-desmethyl metabolite into transitional breast milk. Br J Clin Pharmacol 2008;65:661-6.
33.Padma-Nathan H, McMurray JG, Pullman WE, et al. On-demand IC351 (Tadalafil) enhances erectile function in patients with erectile dysfunction. Int J Impot Res 2001;13:2-9.
34.Pomeranz HD, Bhavsar AR. Nonarteritic ischemic optic neuropathy developing soon after use of sildenafil (Viagra): a report of seven new cases. J Neuroophthalmol 2005;25:9-13.
35.Escaravage GK Jr, Wright JD Jr, Givre SJ. Tadalafil associated with anterior ischemic optic neuropathy. Arch Ophthalmol 2005;123(3):399-400.
36.Bollinger K, Lee MS. Recurrent visual field defect and ischemic optic neuropathy associated with tadalafil rechallenge. Arch Ophthalmol 2005;123(3):400-1.
37.Peter NM, Singh MV, Fox PD. Tadalafil-associated anterior ischaemic optic neuropathy. Eye 2005;19(6):715-7.

Legal Disclaimer: All information presented in this website is intended for informational purposes only and not for the purpose of rendering medical advice.

Get Started For $99 Initial Provider Consult