Safety & Prescribing Information

Important Safety Information for Sildenafil-, Tadalafil-, and Combination-Based Therapies

Sildenafil and Tadalafil are prescription medications approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED).

Some of our personalized compounded formulations may contain Sildenafil and/or Tadalafil in combination with other prescription ingredients such as Oxytocin, Testosterone, Sermorelin, or Bremelanotide (PT-141).

All medications are prescription-only and must be used under the supervision of a licensed healthcare provider.

Compounded combination medications are not FDA-approved as combination products. They are prepared by licensed 503A compounding pharmacies pursuant to a valid prescription.

What These Medications Do

Sildenafil and Tadalafil belong to a class of drugs called PDE5 inhibitors. They work by increasing blood flow to the penis during sexual stimulation.

They:

  • Do not cause automatic erections
  • Do not increase penis size
  • Do not increase sexual desire on their own

 
When included in compounded formulations, they may be combined with other agents that act on hormonal or neurological pathways.

1. INDICATIONS AND USAGE

Sildenafil (Generic for Viagra®)

Sildenafil is indicated for the treatment of erectile dysfunction (ED) in adult males.

Tadalafil (Generic for Cialis®)

Tadalafil is indicated for the treatment of erectile dysfunction (ED) in adult males.
Tadalafil may be prescribed as needed or once daily, as determined by a healthcare provider.

Compounded Combination Therapies

Certain patients may be prescribed compounded medications that contain Sildenafil and/or Tadalafil in combination with other active ingredients, including but not limited to:

  • Oxytocin
  • Testosterone
  • Sermorelin
  • Bremelanotide (PT-141)

 
These compounded preparations are customized pursuant to a valid prescription and are prepared by licensed 503A compounding pharmacies.

Compounded combination products are not FDA-approved and have not undergone FDA review for safety or efficacy as combination formulations.

2. DOSAGE AND ADMINISTRATION

Dosage must be individualized based on patient health status, concomitant medications, and treatment goals.

Sildenafil

Typical starting dose: 25 mg, 50 mg, or 100 mg
Administration: Approximately 30–60 minutes prior to sexual activity
Maximum frequency: Once daily

Tadalafil (As Needed)

Typical dose: 5 mg, 10 mg, or 20 mg
Maximum frequency: Once daily

Tadalafil (Daily Use)

Typical dose: 2.5 mg or 5 mg once daily

Compounded Formulations

Compounded medications may be dispensed as:

  • Sublingual troches
  • Orally disintegrating tablets
  • Capsules
  • Topical or injectable hormonal preparations (if prescribed separately)

Dosing varies by formulation and must not be altered without medical supervision.

3. CONTRAINDICATIONS

Sildenafil, Tadalafil, and compounded formulations containing these agents are contraindicated in patients who:

  • Use organic nitrates in any form (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
  • Use guanylate cyclase stimulators (e.g., riociguat)
  • Have known hypersensitivity to any PDE5 inhibitor

 
Concomitant use with nitrates may result in severe hypotension.

4. WARNINGS AND PRECAUTIONS

Cardiovascular Risk

Sexual activity carries inherent cardiovascular risk. Patients with underlying cardiovascular disease should be evaluated prior to treatment. Use caution in patients with:
  • Recent myocardial infarction or stroke
  • Uncontrolled hypertension
  • Severe hypotension
  • Unstable angina
  • Advanced heart failure

Hypotension

PDE5 inhibitors may cause systemic vasodilation and blood pressure reduction. Caution is advised when co-administered with:

  • Alpha-blockers
  • Antihypertensives
  • Alcohol

Priapism

Prolonged erections greater than 4 hours may occur. Immediate medical intervention is required to prevent permanent injury.

Visual and Auditory Disturbances

Sudden vision loss (NAION) and sudden hearing loss have been reported rarely.

Discontinue use and seek immediate medical attention if these occur.

5. ADDITIONAL PRECAUTIONS FOR COMPOUNDED COMPONENTS

Testosterone (If Prescribed)

Testosterone therapy may increase the risk of:

  • Polycythemia 
  • Prostate enlargement 
  • Worsening sleep apnea 
  • Cardiovascular events (in certain populations) 

 
Requires laboratory monitoring.

Bremelanotide (PT-141)

May cause:

  • Transient increases in blood pressure
  • Nausea
  • Flushing

Contraindicated in uncontrolled hypertension or severe cardiovascular disease.

Sermorelin

May affect growth hormone pathways and requires periodic clinical evaluation.

Oxytocin

May cause headache, flushing, or blood pressure changes.

6. ADVERSE REACTIONS

Common Adverse Reactions (PDE5 Inhibitors)

  • Headache 
  • Flushing 
  • Nasal congestion 
  • Dyspepsia 
  • Dizziness 
  • Back pain (more common with Tadalafil) 
  • Myalgia 

Additional Possible Reactions (Combination Therapy)

  • Nausea 
  • Transient blood pressure changes 
  • Hormonal fluctuations (with TRT) 
  Adverse reactions may vary based on individual formulation.

7. DRUG INTERACTIONS

Use caution when administered with:

  • Nitrates (contraindicated)
  • Alpha-blockers
  • Antihypertensives
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
  • Other erectile dysfunction medications

Patients must disclose all prescription, over-the-counter, and recreational drug use.

8. USE IN SPECIFIC POPULATIONS

Not indicated for use in: 

  • Women (unless specifically prescribed compounded therapy under provider supervision) 
  • Pediatric patients 

Caution in patients with: 

  • Severe hepatic impairment 
  • Severe renal impairment 

Dose adjustments may be required. 

9. OVERDOSAGE

In case of suspected overdose, seek immediate medical attention.

10. TELEHEALTH DISCLOSURE

All prescriptions are issued by licensed U.S. healthcare providers following review of patient medical history and, when appropriate, laboratory testing.

Not all patients are candidates for therapy.

Compounded medications are prepared pursuant to Section 503A of the Federal Food, Drug, and Cosmetic Act.

This document does not replace individualized medical advice.