INTRODUCTION
THIS INFORMED CONSENT (THE "CONSENT") FOROXYTOCIN/BREMELANOTIDE/TADALAFIL MINI TROCHES SETS FORTH THE TERMS AND POLICIESFOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, ACALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICALGROUPS (COLLECTIVELY, THE "MEDICAL GROUPS") THROUGH THE ONLINETECHNOLOGY PLATFORM ("PLATFORM" OR "SUPERPOWER PLATFORM"),WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC.("SUPERPOWER").
The purpose of this consent is to provide you withinformation about the risks, benefits, and safety considerations associatedwith Oxytocin/Bremelanotide/Tadalafil mini troches in order for you to make aninformed decision as to whether or not to proceed with treatment, as well as toobtain your agreement to adhere to the treatment protocol as prescribed by yourMedical Group healthcare provider ("Healthcare Provider"). Pleaseread this form carefully and ask any questions you have before signing.
GENERAL INFORMATION
Oxytocin, Bremelanotide, and Tadalafil are active compoundscombined in mini troches to support sexual health, intimacy, and overallwell-being.
How do these compounds work?
- Oxytocin: Known as the "love hormone," oxytocin enhances emotional bonding, reduces stress, and supports sexual arousal. Oxytocin is FDA approved for use in certain obstetric situations but its use to support sexual health, intimacy and overall well-being is not FDA-approved (i.e., off-label use).
- Bremelanotide: A melanocortin receptor agonist that enhances sexual desire and arousal by acting on the central nervous system. It is FDA-approved for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women and is also used off-label for sexual enhancement in men and women.
- Tadalafil: A PDE-5 inhibitor that improves blood flow, supporting erectile function in men and increased genital blood flow in women. Tadalafil is an FDA-approved medication for the treatment of erectile dysfunction.
Potential Benefits:
- Enhances sexual desire, arousal, and satisfaction.
- Improves emotional bonding and intimacy.
- Supports erectile function and sexual performance.
Potential Side Effects:
- Oxytocin: Mild nausea/vomiting, dizziness, or headache. High and low oxytocin levels are possible, but research has not yet found any implications of these conditions. Long term use is not recommended in men due to enlargement of the prostate gland.
- Bremelanotide: Nausea, flushing, or temporary changes in blood pressure. PT-141 can decrease heart rate and increase blood pressure, so it should be used cautiously in patients with cardiovascular disease.
Tadalafil: Mild headache, nasal congestion, orflushing. Rarely, prolonged erection (priapism) or significant rise or drop inblood pressure. Other potential significant but rare side effects include: Suddenvision loss in one or both eyes (non-arteritic anterior ischemic opticneuropathy, NAION); Sudden hearing decrease or loss, which may be accompaniedby dizziness and ringing in the ears; myocardial infarction and stroke.
These are not all the possible side effects and risksassociated with Oxytocin/Bremelanotide/Tadalafil mini troches.
TREATMENT PROTOCOL
Your Healthcare Provider will determine the appropriatedosage and frequency based on your medical history, goals, and symptoms.
Standard Usage Instructions:
- Dosing: Dissolve one troche under the tongue 30-60 minutes before sexual activity or as prescribed.
- Frequency: Do not exceed the prescribed dosage or use more than once daily unless directed by your Healthcare Provider.
- Storage: Keep troches in a cool, dry place out of reach of children.
Monitoring Requirements:
- Report any new or worsening side effects to your Healthcare Provider.
- Periodic follow-up may be recommended to evaluate effectiveness and adjust the dosage if necessary.
Adherence:
It is critical to adhere to the prescribed usage instructions to minimize risksand optimize benefits.
ALTERNATIVES TO OXYTOCIN/BREMELANOTIDE/TADALAFIL MINITROCHES
There are alternative treatments for sexual health andintimacy, including:
- Lifestyle changes such as exercise, stress management, and diet modifications.
- Other medications or therapies, such as oral PDE-5 inhibitors or counseling.
- Non-prescription supplements targeting sexual health.
These alternatives may or may not provide the same benefitsas Oxytocin/Bremelanotide/Tadalafil mini troches and should be discussed withyour Healthcare Provider.
CONTRAINDICATIONS
You should not use Oxytocin/Bremelanotide/Tadalafil minitroches if:
- You have an allergy or known hypersensitivity to any of its components.
- You are taking nitrates (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate), as combining them with Tadalafil can cause a dangerous drop in blood pressure.
- You are taking guanylate cyclase stimulators (e.g., riociguat)
- Oxytocin aggravates Benign Prostate Hyperplasia (BPH) thus should not be used in patients with BPH as well as patients with prostate cancer. Oxytocin should also be avoided in patients with uterine cancer, manic episodes and patients on naltrexone therapy
- You have significant or recent cardiovascular, kidney, or liver disease without consulting your Healthcare Provider.
- You are pregnant, breastfeeding, or planning to become pregnant without consulting your Healthcare Provider.
ADDITIONAL SAFETY INFORMATION
- Inform your Healthcare Provider of all medications, supplements, and medical conditions to avoid potential interactions.
- Avoid alcohol or recreational drugs during use, as they may enhance side effects or interfere with the effectiveness of treatment.
- Do not eat grapefruit or drink grapefruit juice while you are using the troches. Grapefruit and grapefruit juice may change the amount of the Oxytocin, Bremelanotide, and Tadalafil that is absorbed in the body.
- If you experience severe side effects, such as chest pain, shortness of breath, or a prolonged erection lasting more than 4 hours, seek immediate medical attention.
When usingoxytocin it is important to have normal thyroid function since oxytocin isregulated by thyroid as well as estrogen hormones. It is also important tomaintain adequate intake of magnesium, zinc, and vitamin C.
USE OF TELEHEALTH
Your Clinical Services will be provided via telehealth.Telehealth involves the use of electronic communication for diagnosis,treatment, and follow-up care. By agreeing to this Consent, you acknowledge thefollowing:
- Telehealth provides improved access to care but may limit the ability to perform a full physical examination.
- There are potential risks, including delays due to technical issues or security breaches.
- You must be physically located in the state where your Healthcare Provider is licensed during telehealth visits.
INFORMED CONSENT & ADHERENCE TO TREATMENT PLAN
By signing this informed consent, you acknowledge that you:
- Have read and understood the information provided about Oxytocin/Bremelanotide/Tadalafil mini troches, including its risks, benefits, and safety considerations.
- Agree to adhere to the treatment protocol as prescribed by your Healthcare Provider and report any severe side effects or concerns promptly.
- Understand that there are no guarantees or assurances regarding treatment outcomes.
- Certify that you have disclosed all relevant health information, including allergies, medications, and medical history.
CERTIFICATION OF CONSENT
By clicking "I AGREE" or signing below, youcertify that:
- You have read and understood this entire Informed Consent.
- You have had the opportunity to ask questions, and all your questions have been answered to your satisfaction.
- You freely and voluntarily accept all risks associated with Oxytocin/Bremelanotide/Tadalafil mini troches and consent to proceed with treatment.
MEMBER NAME: ___________________________
SIGNATURE: ______________________________
DATE: ____________________________________
