Tadalafil / Oxytocin ODT is a compounded formulation designed to enhance male sexual performance, particularly for:

• Erectile Dysfunction (ED)

• Low libido

• Psychogenic sexual dysfunction

The ODT (orally disintegrating tablet) form allows for rapid mucosal absorption, bypassing first-pass metabolism and resulting in faster onset of action.

• Tadalafil: Long-acting PDE5 inhibitor – improves penile blood flow

• Oxytocin: Neuropeptide hormone – modulates social bonding, sexual arousal, and emotional connection

This combination aims to target both physiological erection and psychological/behavioral arousal pathways.

Tadalafil:

• Inhibits Phosphodiesterase type 5 (PDE5)

• Increases cGMP levels in penile smooth muscle

• Causes vasodilation, enhancing blood flow to the corpus cavernosum

• Supports firm, sustained erections during sexual stimulation

Oxytocin:

• Acts on oxytocin receptors (OXTR) in the central nervous system and peripheral tissues

• Facilitates emotional bonding, sexual receptivity, and orgasmic intensity

• May enhance dopamine release, reduce anxiety, and improve sexual satisfaction

• Peripheral vasodilation effects may also slightly enhance blood flow

✅ Together, they work on both physical (erection) and emotional (desire/arousal) components of sexual response.

Contraindications:

• Use of nitrate medications (e.g., nitroglycerin) – risk of severe hypotension

• Known hypersensitivity to tadalafil or oxytocin

• Recent cardiovascular events (MI, stroke, unstable angina)

• Severe renal or hepatic impairment

• History of priapism or anatomical penile deformities

Precautions:

• Caution in patients with hypotension or volume depletion

• Psychiatric disorders (oxytocin may affect mood)

• History of seizure disorder

• Caution in individuals using other CNS-acting agents (e.g., antidepressants)

• Avoid combining with alpha-blockers without medical supervision

• Not studied in individuals with low testosterone or endocrine disorders

Pharmacodynamic Interactions:

• Nitrates or nitric oxide donors → life-threatening hypotension

• Alpha-blockers (e.g., tamsulosin) → risk of additive hypotension

• Alcohol → enhanced vasodilatory effects; may increase dizziness or hypotension

• CNS depressants (e.g., benzodiazepines) → potential additive sedation (via oxytocin)

Pharmacokinetic Interactions:

• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) → increase tadalafil levels

• CYP3A4 inducers (e.g., rifampin) → may reduce tadalafil efficacy

Oxytocin’s metabolic pathway is less well-defined, but it may interact with dopaminergic or serotonergic systems, so caution is advised with SSRIs, SNRIs, MAO inhibitors, and dopamine agonists.

Tadalafil-Related:

• Headache

• Facial flushing

• Nasal congestion

• Dyspepsia

• Back/muscle pain

• Rare: Priapism, vision/hearing changes

Oxytocin-Related:

• Mild nausea or headache

• Emotional sensitivity or transient mood changes

• Anxiety or overstimulation (rare)

• Vasodilation-related symptoms: lightheadedness, hypotension

ODT-Specific Effects:

• Oral tingling or taste disturbances (bitter or sweet taste)

• Mild oral mucosal irritation in sensitive individuals

Pregnancy:

• Tadalafil: Animal studies show no harm, but human data lacking; not indicated during pregnancy

• Oxytocin: Uterotonic agent — can induce uterine contractions, miscarriage, or preterm labor

• Contraindicated in pregnancy

Breastfeeding:

• Tadalafil: Unknown if excreted in human milk

• Oxytocin: Naturally present during breastfeeding but exogenous oxytocin may alter milk letdown reflex

• Use during breastfeeding is not recommended

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.

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. Melis MR, Argiolas A. Oxytocin, Erectile Function and Sexual Behavior: Last Discoveries and Possible Advances. Int J Mol Sci. 2021 Sep 26;22(19):10376. doi: 10.3390/ijms221910376. PMID: 34638719; PMCID: PMC8509000. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509000/– LinkOpens in New Tab
3. Cialis (tadalafil) package insert. Indianapolis, IN: Lilly ICOS, LLC; 2011 Oct.
4. Adcirca (tadalafil) package insert. Indianapolis, IN: Lilly ICOS, LLC; 2011 Apr.
5. Cleveland Clinic. (2022, March 27). Oxytocin. Cleveland Clinic. https://my.clevelandclinic.org/health/articles/22618-oxytocin#:~:text=In%20people%20assigned%20male%20at%20birth%20(AMAB)%2C%20oxytocin%20plays,sex%20hormone)%20in%20the%20testes.– LinkOpens in New Tab
6. Hemlata Thackare and others, Oxytocin—its role in male reproduction and new potential therapeutic uses, Human Reproduction Update, Volume 12, Issue 4, July/August 2006, Pages 437–448, https://academic.oup.com/humupd/article/12/4/437/2182089– LinkOpens in New Tab
7. Argiolas A (1992) Oxytocin stimulation of penile erection. Pharmacology, site, and mechanism of action. Ann N Y Acad Sci 12,194–203.
8. Burnett AL, Bivalacqua TJ. Priapism: current principles and practice. Urol Clin N Am 2007;34:631-642.
9. Bortolotti M, Mari C, Giovannini M, et al. Effects of sildenafil on esophageal motility of normal subjects. Dig Dis Sci 2001;46:2301-2306.
10. Lerman B, Harricharran T, Ogunwobi OO. Oxytocin and cancer: An emerging link. World J Clin Oncol. 2018 Sep 14;9(5):74-82. doi: 10.5306/wjco.v9.i5.74. PMID: 30254962; PMCID: PMC6153127. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153127/#:~:text=Analysis%20of%20serum%20and%20tissue,from%20patients%20without%20prostate%20cancer.– LinkOpens in New Tab
11. Xu H, Fu S, Chen Q, Gu M, Zhou J, Liu C, Chen Y, Wang Z. The function of oxytocin: a potential biomarker for prostate cancer diagnosis and promoter of prostate cancer. Oncotarget. 2017 May 9;8(19):31215-31226. doi: 10.18632/oncotarget.16107. PMID: 28415720; PMCID: PMC5458202. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5458202/– LinkOpens in New Tab
12. Kwon Wook Joo and others, Antidiuretic action of oxytocin is associated with increased urinary excretion of aquaporin-2, Nephrology Dialysis Transplantation, Volume 19, Issue 10, October 2004, Pages 2480–2486, https://doi.org/10.1093/ndt/gfh413– LinkOpens in New Tab or https://academic.oup.com/ndt/article/19/10/2480/1925723– LinkOpens in New Tab
13. American College of Obstetrics and Gynecology (ACOG). ACOG Practice Bulletin Number 10: Clinical Management Guidelines for Obstetrician-Gynecologists. Induction of labor. Washington, DC: American College of Obstetricians and Gynecologists; November 1999.
14. Mangesi L, Dowswell T. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2010;9:CD006946.
15. Cialis® (tadalafil) package insert. Indianapolis, IN: Lilly ICOS, LLC; 2007 Jan.
16. Sustiva (efavirenz) package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2014 May.
17. Intelence (etravirine) package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2014 Aug.
18. Mifeprex (mifepristone, RU-486) package insert. New York, NY: Danco Laboratories, LLC; 2009 Apr.
19. Korlym (mifepristone) tablet package insert. Menlo Park, CA: Corcept Therapeutics Incorporated; 2013 Jun.
20. Hansten P, Horn J. The Top 100 Drug Interactions: A Guide to Patient Management. includes table of CYP450 and drug transporter substrates and modifiers (appendices). H & H Publications, LLP 2014 edition.
21. Tasigna® (nilotinib) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2007 Oct.
22. Kuvan (sapropterin) package insert. Novato, CA: BioMarin Pharmaceutical Inc; 2014 April.
23. Adalat CC (nifedipine extended-release tablets) package insert. West Haven, CT: Bayer Pharmaceuticals Corporation; 2010 Aug.
24. Levitra® (vardenafil) package insert. Kenilworth, NJ: Schering-Plough; 2007 Mar.
25. Ketek (telithromycin) package insert. Bridgewater, NJ: Sanofi-Aventis Pharmaceuticals; 2010 Dec.
26. Incivek (telaprevir) tablet package insert. Cambridge, MA: Vertex Pharmaceuticals, Inc; 2013 Oct.
27. Pitocin® (oxytocin injection, USP) package insert. Rochester, MI: Monarch Pharmaceuticals; 2003 Jan.
28. Halothane, USP package insert. North Chicago, IL: Abbott Laboratories; 1998 Mar.
29. 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.
30. 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.
31. Escaravage GK Jr, Wright JD Jr, Givre SJ. Tadalafil associated with anterior ischemic optic neuropathy. Arch Ophthalmol 2005;123(3):399-400.
32. Bollinger K, Lee MS. Recurrent visual field defect and ischemic optic neuropathy associated with tadalafil rechallenge. Arch Ophthalmol 2005;123(3):400-1.
33. Peter NM, Singh MV, Fox PD. Tadalafil-associated anterior ischaemic optic neuropathy. Eye 2005;19(6):715-7.
34. Pitocin (oxytocin) package insert. Rochester, MI: JHP Pharmaceuticals, LLC; 2014 Sept.
35. Curless RV, Beaumont DM, Sinar EJ, et al. Subarachnoid hemorrhage mimicking acute water intoxication during labour augmented by oxytocin infusion. Br J Clin Pract 1990;44(12):637-638.