| Category Name | Content |
| Name | Compounded & Branded Erectile Dysfunction Treatment Protocol |
| Uses | Treatment of erectile dysfunction (ED) using FDA-approved medications such as Viagra (Sildenafil), Cialis (Tadalafil), Levitra (Vardenafil), Spedra (Avanafil), and compounded alternatives. These medications improve blood flow to the penis, enhancing erectile function. |
| Route Of Administration | Oral tablets, taken as needed or daily (Tadalafil). |
| Frequency Of Use | As needed before sexual activity or once daily (for Tadalafil 5mg daily therapy). |
| Concentration(s) | Sildenafil: 25mg, 50mg, 100mg. Tadalafil: 10mg, 20mg (as-needed) or 5mg (daily). Vardenafil: 10mg, 20mg. Avanafil: 100mg, 200mg. |
| Maximum Dosage (Day, Wk) | Maximum of one dose per day for all medications. Patients should not take multiple PDE5 inhibitors concurrently. |
| Contraindications | Do not use in patients with severe cardiovascular disease, recent stroke or heart attack, uncontrolled hypertension, hypotension, severe liver disease, or active retinal disorders. Absolute contraindication with nitrates or riociguat (Adempas). |
| Possible Side Effects | Common: Headache, flushing, nasal congestion, upset stomach, dizziness. Rare: Priapism (erection >4 hours), vision changes, hearing loss, severe hypotension, heart attack (in at-risk patients). |
| Compatibility With Other Treatments/Drugs | Do not use with nitrates (e.g., nitroglycerin), guanylate cyclase stimulators (riociguat), or significant alpha-blockers. Use caution with antihypertensives and CYP3A4 inhibitors. |
| Allergies | Ensure no known allergy to PDE-5 inhibitors or excipients in medications. |
| Administration Time | Sildenafil: 1 hour before sexual activity. Tadalafil: 30-60 minutes before sexual activity (as needed) or once daily. Vardenafil: 1 hour before. Avanafil: 15-30 minutes before. |
| Dosing/Settings | - Sildenafil: 50mg initially, adjust to 25mg or 100mg based on response. - Tadalafil: 10mg initially, adjust to 20mg based on response. Daily dose: 5mg. - Vardenafil: 10mg initially, adjust as needed. - Avanafil: 100mg initially, adjust to 200mg if needed. |
| Pre-Treatment Guidelines | Patients should be assessed for cardiovascular risk before starting PDE5 inhibitors. Patients with unexplained fainting, priapism history, or severe erectile dysfunction should consult a specialist. |
| Provider Clearance Guidelines | Defer treatment in patients with uncontrolled cardiovascular disease, severe liver impairment, or those on contraindicated medications. Ensure normal genital/prostate exam within the past 3 years. |
| Pre-Treatment Screening Workflow | 1. History of heart disease, uncontrolled BP, or recent stroke? If YES, defer. 2. Taking nitrates or Adempas? If YES, defer. 3. History of priapism? If YES, defer. 4. SHIM score 21 or lower? If YES, candidate for ED treatment. |
| What To Do If Adverse Reaction Occurs | For mild side effects (headache, flushing), recommend dose reduction. For priapism (erection >4 hours), refer to emergency care immediately. |
| Clinic Implementation Guidelines | Confirm patient consent. Review medical history for contraindications. Educate patients on proper use and when to seek medical attention. |
| Photographic Documentation Protocol | Not required for this treatment. |
| Post-Treatment Care | Monitor for side effects, adjust dosage as needed. Advise lifestyle modifications to improve ED symptoms. |
| Additional Documentation Requirements | Signed informed consent, SHIM score assessment, cardiovascular risk evaluation, and medication logs. |