Important Safety Information: Sildenafil (Sildenafil Citrate) | Compounded Troche

What is this?

This Important Safety Information summarizes key warnings and precautions for Sildenafil Citrate, a phosphodiesterase type 5 (PDE-5) inhibitor. Sildenafil was originally developed for pulmonary hypertension and certain cardiovascular conditions but is most commonly prescribed for erectile dysfunction (ED). It works by increasing blood flow to specific areas of the body through inhibition of the PDE-5 enzyme, which is highly concentrated in the corpus cavernosum of the penis.

This compounded troche formulation dissolves in the mouth and should only be used exactly as directed by a licensed healthcare provider. Compounded medications are not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. This summary does not include all available information. Always follow your provider’s instructions and read your medication label carefully.

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including swelling of the face, lips, tongue, or throat

• Severe low blood pressure (hypotension), especially when taken with nitrates

• Fainting (syncope)

• Myocardial infarction (heart attack)

• Sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION)

• Sudden hearing loss

• Seizures

• Serious cardiovascular events in individuals with underlying heart disease

Compounded Sildenafil may carry formulation risks due to limited FDA oversight.

Who Should NOT Take Sildenafil

Do not take this medication if you:

• Have a known hypersensitivity or allergy to Sildenafil or any component of the formulation

• Take nitrate medications for chest pain or heart disease

• Use recreational nitrates (“poppers”)

• Have been advised by your provider to avoid sexual activity due to cardiovascular risk

• Have experienced vision loss related to NAION

Before Taking Sildenafil, Tell Your Healthcare Provider if You:

• Have heart disease, arrhythmias, aortic stenosis, heart failure, or history of heart attack

• Have low or uncontrolled high blood pressure

• Have liver disease

• Have kidney disease

• Have a history of vision disorders or optic nerve problems

• Have a history of hearing problems

• Take any prescription, over-the-counter, herbal, or recreational substances

• Smoke, drink alcohol, or use street drugs

Sildenafil is metabolized in the liver (CYP3A4 and CYP2C9 pathways). Liver or kidney disease may increase drug levels and prolong effects.

Possible Side Effects

Common (mild to moderate):

• Headache

• Flushing

• Nasal congestion

• Dizziness

• Indigestion or gastritis

• Visual disturbances (blurred vision, color changes)

Serious (seek medical care immediately):

• Chest pain

• Sudden vision loss

• Sudden hearing loss

• Severe dizziness or fainting

• Signs of severe allergic reaction

• Seizures

• Symptoms of severe hypotension

While Taking Sildenafil

Tell your healthcare provider immediately if you:

• Experience chest pain during sexual activity

• Develop sudden vision or hearing changes

• Feel faint, dizzy, or lightheaded

• Have symptoms that do not improve or worsen

• Experience any unusual or severe side effects

Do not combine with nitrate therapy under any circumstances.

Pregnancy and Use in Women

Sildenafil is classified as Pregnancy Category B. It is not routinely indicated for use in women. Clinical benefit in women has not been clearly established. Use during pregnancy or breastfeeding should only occur under direct medical supervision.

Overdose

Symptoms of overdose may include:

• Severe dizziness or fainting

• Visual or hearing disturbances

• Chest pain

• Severe hypotension

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

Missed Dosage

If you miss a dose:

• Take it when you remember, unless it is near the time of your next scheduled dose

• Do not double the dose

• Contact your provider if you are unsure how to proceed

Sildenafil troches are typically taken as directed prior to anticipated activity.

Storage

• Keep out of reach of children and pets

• Store at room temperature unless otherwise directed

• Protect from moisture and heat

• Follow beyond-use date on your pharmacy label

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication down drains. Consult your pharmacy or local take-back programs for safe disposal options.

Provider Oversight and Order Review

This compounded medication requires review and oversight by a licensed Superior Health & Wellness provider. Dosing and frequency must be individualized based on medical history and cardiovascular risk. Orders may be adjusted based on response, tolerability, or underlying health conditions.

Telemedicine Disclosure

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

Disclaimer

This summary does not include all information about Sildenafil and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information 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.