Oxytocin / Vardenafil – Gel Troche

(Ship Cold)

Available Dosage Strengths

125 U / 20 mg

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Product Overview

Oxytocin Description1-8

Oxytocin is produced in the hypothalamus and stored in the posterior portion of the pituitary gland. Oxytocin is made synthetically and has activity identical to natural oxytocin. Oxytocin stimulates contraction of smooth muscle in the uterus during labor and stimulates the alveolar ducts to eject milk after it has been produced in the breast. Thus, because of the actions of oxytocin on the uterus, it has been used to induce labor, aid in the delivery of the placenta, and control postpartum bleeding. Oxytocin has also been associated with social bonding, mood regulation and sexual functioning.

Vardenafil Description1-8

Vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, has a mean terminal half-life of 4 to 6 hours. It is effective and generally well tolerated. Vardenafil is a potent and highly selective oral PDE5 inhibitor. The drug is indicated for erectile dysfunction and it is used for on-demand use for this indication.

Oxytocin1-9

Oxytocin causes G-protein coupled receptors to increase intracellular calcium which leads to uterine contraction. The stimulation of uterine contractions causes more oxytocin to be released. As more oxytocin is released it positively influences even more release of oxytocin. This release of oxytocin is called positive feedback which is much different than how many hormones work in the endocrine system. Oxytocin administered exogenously causes the same response as endogenously produced oxytocin. Not only does oxytocin stimulate uterine contractions, but it also causes contractions of myoepithelial cells in the alveolar ducts found in female breast tissue. These contractions force milk from these ducts into even larger sinuses, which subsequently enables milk expulsion. When a baby attempts to latch onto the mother’s breast it causes oxytocin secretion into the blood in the same manner as vaginal delivery; instead of uterine contractions, milk is ejected from the breast. Similar to the actions of oxytocin in the uterus to stimulate contractions during delivery, milk-ejection from breast tissue occurs due to positive feedback. In the brain, it is proposed that oxytocin stimulates social and sexual function by its activity in many areas of the brain including its activity on neurotransmitters.

Vardenafil1-9

Phosphodiesterase (PDE) has many isoforms and is an enzyme that has many functions in the body including degrading the effect of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). PDE5 is an enzyme that is found in many parts of the body including in the smooth muscle of the corpus cavernosum, prostate, bladder, the vascular and visceral smooth muscle, skeletal muscle, urethra, platelets, kidney, lung, cerebellum, heart, liver, testis, seminal vesicle, and pancreas. Vardenafil is a selective inhibitor of PDE5, the enzyme responsible for the degradation of cGMP. Vardenafil’s activity on PDE5 has been shown to be approximately 10 fold to 25 fold more than sildenafil. Increased cGMP leads to smooth muscle relaxation in the corpus cavernosum which can help in maintaining an erection.

Oxytocin / Common 1,2,7,8

  • Loss of appetite
  • Nausea, vomiting
  • Stomach pain

Vardenafil / Common 1,2,7,8

  • Headache
  • Flushing
  • Rhinitis
  • Dyspepsia, vomiting
  • Dizziness

Oxytocin1,2,7,8

Contraindications

  • Known hypersensitivity to oxytocin
  • Pregnancy 1st or 2nd trimester

Precautions

  • Oxytocin may possess antidiuretic effects—extended administration may increase risk of fluid overload
  • Cardiovascular disease, due to oxytocin’s potential vasopressor effects

 

Vardenafil1,2,7,8

Contraindications

  • Known hypersensitivity to vardenafil or tablet excipients
  • Use of nitrates and guanylate cyclase (GC) stimulators therapy, such as riociguat due to risk of life-threatening hypotension

Precautions

  • Use with caution in patients with:
  • Severe hepatic impairment (Child-Pugh Class C)
  • Severe renal impairment (end stage renal disease)
  • History of NAION (non-arteritic anterior ischemic optic neuropathy)
  • Recent history of myocardial infarction, stroke, or unstable angina

Store at 20°C to 25°C (68°F to 77°F) in a cool, dry place.

  1. Oxytocin Prescribing Information – Fresenius Kabi. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018248s049lbl.pdf Revised September 2022. Accessed May 31, 2025
  2. Clinical Pharmacology Oxytocin clinical monograph 2025 https://www.clinicalkey.com/pharmacology/
  3. Osilla EV, Patel P, Sharma S. Oxytocin. [Updated 2025 Feb 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507848/
  4. Kou J, Lan C, Zhang Y, Wang Q, Zhou F, Zhao Z, Montag C, Yao S, Becker B, Kendrick KM. In the nose or on the tongue? Contrasting motivational effects of oral and intranasal oxytocin on arousal and reward during social processing. Transl Psychiatry. 2021 Feb 4;11(1):94.
  5. Zhuang Q, Zheng X, Yao S, Zhao W, Becker B, Xu X, Kendrick KM. Oral Administration of Oxytocin, Like Intranasal Administration, Decreases Top-Down Social Attention. Int J Neuropsychopharmacol. 2022 Nov 17;25(11):912-923.
  6. Quintana DS, Glaser BD, Kang H, Kildal ESM, Audunsdottir K, Sartorius AM, Barth C. The interplay of oxytocin and sex hormones. Neurosci Biobehav Rev. 2024 Aug;163:105765.
  7. Clinical Pharmacology Vardenafil clinical monograph 2025 https://www.clinicalkey.com/pharmacology/
  8. Vardenafil package insert. Bayer Healthcare Pharmaceuticals, Inc. Revised April 2014. Accessed June 12, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021400s017lbl.pdf.
  9. Keating GM, Scott LJ. Vardenafil: a review of its use in erectile dysfunction. Drugs. 2003;63(23):2673-703.

This sheet is a summary. It may not cover all possible drug information about this product. Call your doctor for medical advice and/or about side effects. You may report side effects to the FDA at 1-800-FDA-1088.  A Wells Pharmacy Network pharmacist will be happy to answer any questions. For consultation, please call 1-800-622-4510.

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