Important Safety Information: Oxytocin / Sildenafil | Compounded Troche

What is this?

This Important Safety Information summarizes key warnings and precautions for Oxytocin combined with Sildenafil in a compounded troche formulation.

Oxytocin is a naturally occurring hormone involved in bonding, intimacy, and smooth muscle contraction. Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor commonly used to support erectile function by increasing blood flow.

This compounded troche formulation is prescribed for individualized use under provider supervision. It is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. It should only be used exactly as directed by a licensed healthcare provider.

This summary does not include all available information. Always read your medication label and follow your provider’s instructions.

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including anaphylaxis

• Sudden drop in blood pressure, especially if taken with nitrates or certain cardiovascular medications

• Chest pain or cardiovascular complications

• Severe headache, dizziness, or fainting

• Vision changes or sudden vision loss

• Prolonged or painful erection lasting more than 4 hours (priapism)

• Neurological symptoms such as confusion, seizures, or weakness on one side of the body

Compounded medications may carry sterility or formulation risks due to limited FDA oversight.

Who Should NOT Take This Medication

Do not take this medication if you:

• Have a known allergy to Oxytocin, Sildenafil, or any ingredient in the formulation

• Use nitrates (such as nitroglycerin, isosorbide dinitrate, or isosorbide mononitrate)

• Use recreational “poppers” containing amyl nitrite or butyl nitrite

• Take riociguat, vericiguat, or certain strong CYP3A4 inhibitors such as ketoconazole or ritonavir without provider clearance

• Have pulmonary veno-occlusive disease (PVOD)

• Have certain hereditary eye conditions such as retinitis pigmentosa

• Have been advised you are not medically stable enough for sexual activity

• Are female, pregnant, or breastfeeding unless specifically directed under medical supervision

Before Taking This Medication, Tell Your Healthcare Provider if You:

• Have heart disease, high blood pressure, low blood pressure, or a history of stroke

• Have a history of arrhythmias or abnormal heart rhythms

• Have kidney or liver disease

• Have a history of seizures

• Have bleeding disorders

• Have anatomical deformation of the penis or a history of priapism

• Take any prescription, over the counter, or herbal medications

• Smoke, drink alcohol regularly, or use recreational drugs

Do not start, stop, or change the dose of any medication without speaking to your healthcare provider.

Possible Side Effects

Common (mild to moderate):

• Headache

• Flushing

• Nasal congestion

• Upset stomach or nausea

• Dizziness

• Mild visual changes

• Facial warmth or redness

Serious (seek medical care immediately):

• Swelling of the face, lips, tongue, or throat

• Difficulty breathing or swallowing

• Chest pain or pressure

• Fainting or severe dizziness

• Sudden vision loss or sudden hearing loss

• Seizures

• Severe abdominal pain

• Prolonged erection lasting more than 4 hours

While Taking This Medication

Tell your healthcare provider immediately if you:

• Experience chest pain during sexual activity

• Notice vision or hearing changes

• Develop severe headaches or neurological symptoms

• Have persistent dizziness or fainting

• Experience an erection lasting longer than 4 hours

Avoid combining with alcohol in excess, as this may increase dizziness and blood pressure changes.

Overdose

Symptoms of overdose may include:

• Severe low blood pressure

• Fainting

• Severe headache

• Vision disturbances

• Prolonged erection

If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a dose:

• Take the missed dose when you remember, unless it is close to your next scheduled dose

• Do not double up on doses

• Contact your provider if you are unsure how to proceed

Storage

• Store at room temperature unless otherwise directed

• Protect from moisture and excessive heat

• Keep out of reach of children and pets

• Follow any specific storage instructions on your pharmacy label

Medication Disposal

This product contains hazardous medication. Dispose of unused or expired doses according to local hazardous waste regulations. Do not flush medication unless instructed. Contact your pharmacy for proper disposal guidance.

Provider Oversight and Order Review

This compounded medication requires review and oversight by licensed Superior Health and Wellness providers. Dosing, frequency, and appropriateness must be determined based on individual health status and risk factors. Orders may be adjusted based on cardiovascular history, medication interactions, and overall clinical safety.

Telemedicine Disclosure

This prescription may be issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about Oxytocin and Sildenafil and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations.

This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.