Important Safety Information for Double Powered

What is Double Powered?

Double Powered is a compounded medication containing two PDE5 inhibitors—tadalafil and sildenafil—combined at lower doses to provide both rapid onset and extended duration of action for erectile dysfunction. This combination approach aims to deliver the quick-acting benefits of sildenafil with the longer-lasting effects of tadalafil. Because this is a combination product, all warnings and precautions for both medications apply.

Critical Warning: Nitrate Interaction

Do not take Double Powered if you use any form of nitrate medication. Both tadalafil and sildenafil can cause severe, potentially fatal blood pressure drops when combined with nitrates.

Avoid all forms of nitrates including:

• Nitroglycerin in any form (tablets, sprays, patches, ointments)
• Isosorbide dinitrate or isosorbide mononitrate
• Amyl nitrite or amyl nitrate ("poppers")
• Any medication containing organic nitrates

If you have taken Double Powered and require emergency medical treatment, inform medical personnel immediately so they know to avoid nitrate administration.

Who Should Not Use Double Powered?

Do not use this medication if you:

• Take nitrate medications in any form
• Use recreational "poppers"
• Take riociguat (Adempas) or other guanylate cyclase stimulators
• Are allergic to tadalafil, sildenafil, or any component of this medication
• Have been told by a doctor that sexual activity could be dangerous for your heart
• Have had a heart attack within the past 90 days
• Have unstable angina or chest pain during sexual activity
• Have severe heart failure
• Have uncontrolled high or low blood pressure
• Have had a stroke within the past 6 months
• Have severe liver or kidney disease
• Have retinitis pigmentosa or other hereditary eye conditions
• Take other PDE5 inhibitors

Warnings and Precautions

1. Enhanced Cardiovascular EffectsBecause Double Powered contains two PDE5 inhibitors, cardiovascular effects may be enhanced compared to single-agent therapy. Ensure you have been evaluated for cardiovascular fitness for sexual activity before using this medication. Stop sexual activity and seek immediate medical care if you experience chest pain, shortness of breath, or dizziness.

2. Blood Pressure ConsiderationsThe combination of two PDE5 inhibitors may have a greater effect on blood pressure than either agent alone. Use extreme caution if you take blood pressure medications, particularly alpha-blockers. Report any episodes of dizziness, lightheadedness, or fainting to your healthcare provider.

3. Sudden Vision LossBoth sildenafil and tadalafil have been associated with non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden, permanent vision loss. Stop using Double Powered immediately and seek emergency care if you experience sudden vision loss or changes in vision.

4. Sudden Hearing LossSudden decrease or loss of hearing has been reported with PDE5 inhibitors. Discontinue use and contact your healthcare provider immediately if you experience any hearing changes.

5. Prolonged Erection (Priapism)An erection lasting more than 4 hours is a medical emergency requiring immediate treatment. The risk of priapism may be increased with combination therapy. If you have conditions that predispose you to priapism (sickle cell disease, multiple myeloma, leukemia), discuss the risks with your provider before using Double Powered.

6. Visual DisturbancesSildenafil may cause temporary changes in color vision, including a blue tinge to vision or difficulty distinguishing between blue and green colors. This is usually temporary but should be reported to your healthcare provider.

Common Side Effects

Side effects may include those associated with both sildenafil and tadalafil:

• Headache
• Flushing
• Indigestion or heartburn
• Nasal congestion
• Back pain
• Muscle aches
• Dizziness
• Nausea
• Visual changes (blue tinge, increased brightness)

Drug Interactions

Avoid or use with extreme caution:

• Nitrates – Absolutely contraindicated
• Alpha-blockers – Significant hypotension risk; may require dose adjustments and careful timing
• Other PDE5 inhibitors – Do not combine
• Riociguat – Contraindicated
• Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) – May significantly increase medication levels
• Blood pressure medications – Additive blood pressure lowering effects
• Grapefruit/grapefruit juice – Avoid

Dosing

Take as directed by your healthcare provider. Do not exceed the prescribed dose. Do not take more than once in a 24-hour period. Sexual stimulation is required for the medication to work.

Storage

Store at room temperature. Protect from moisture and light. Keep out of reach of children.

When to Seek Emergency Care

Seek immediate medical attention for:

• Chest pain or pressure during or after sexual activity
• An erection lasting more than 4 hours
• Sudden vision loss or changes
• Sudden hearing loss or ringing in ears
• Severe dizziness or fainting
• Signs of allergic reaction

This is a compounded medication not FDA-approved. Consult your healthcare provider for complete safety information.