Important Safety Information for Triple Powered

What is Triple Powered?

Triple Powered is a compounded medication combining three active ingredients for comprehensive treatment of sexual dysfunction: tadalafil (a long-acting PDE5 inhibitor), sildenafil (a rapid-onset PDE5 inhibitor), and PT-141/bremelanotide (a melanocortin receptor agonist that works on the central nervous system to enhance sexual desire). This combination addresses both the physical and psychological aspects of sexual response. Because this is a combination product, all warnings and precautions for each ingredient apply.

Critical Warnings

Nitrate Contraindication:Do not take Triple Powered if you use any nitrate medications. The combination of PDE5 inhibitors with nitrates can cause dangerous, potentially fatal drops in blood pressure.

Cardiovascular Concerns:Both the PDE5 inhibitor components (tadalafil and sildenafil) and PT-141 can affect blood pressure. PT-141 may cause transient increases in blood pressure, while the PDE5 inhibitors may lower blood pressure. Do not use Triple Powered if you have uncontrolled hypertension or cardiovascular disease.

Who Should Not Use Triple Powered?

Do not use this medication if you:

• Take nitrate medications of any kind
• Use "poppers" (amyl nitrite/nitrate)
• Take riociguat or guanylate cyclase stimulators
• Have uncontrolled high blood pressure
• Have cardiovascular disease, heart failure, or recent heart attack or stroke
• Are allergic to tadalafil, sildenafil, PT-141/bremelanotide, or any component
• Have been advised to avoid sexual activity for medical reasons
• Have retinitis pigmentosa
• Have severe liver or kidney disease
• Are pregnant or breastfeeding (PT-141 component)
• Take other PDE5 inhibitors or sexual enhancement medications

Warnings and Precautions

1. Blood Pressure EffectsThis combination may have complex effects on blood pressure. PT-141 typically causes a mild, temporary increase in blood pressure (approximately 6 mmHg systolic, 3 mmHg diastolic), while the PDE5 inhibitors lower blood pressure. Monitor for symptoms of blood pressure changes including dizziness, lightheadedness, flushing, and headache.

2. Cardiovascular RiskSexual activity itself poses cardiovascular risk. The combination of multiple active ingredients requires that you have been cleared for sexual activity by your healthcare provider. Stop immediately and seek medical care if you experience chest pain, shortness of breath, or severe dizziness during or after use.

3. NauseaPT-141/bremelanotide frequently causes nausea, reported in approximately 40% of users. Nausea is typically most pronounced with initial doses and may decrease with continued use. Your healthcare provider may recommend anti-nausea medication to manage this side effect.

4. Skin Pigmentation ChangesPT-141 may cause darkening of the skin, particularly on the face, gums, or breasts. These changes may be permanent and may be more likely with frequent use (more than 8 doses per month).

5. Vision and HearingThe PDE5 inhibitor components may cause sudden vision loss (NAION) or sudden hearing loss. Stop using Triple Powered and seek immediate medical care if you experience any sudden changes in vision or hearing.

6. Prolonged ErectionThe dual PDE5 inhibitor action may increase the risk of priapism (erection lasting more than 4 hours). This requires immediate medical treatment to prevent permanent damage.

Common Side Effects

Side effects may include those from all three components:

From PDE5 inhibitors (tadalafil/sildenafil):

• Headache
• Flushing
• Indigestion
• Nasal congestion
• Back pain
• Muscle aches
• Visual changes (blue tinge)

From PT-141/bremelanotide:

• Nausea (most common)
• Flushing
• Headache
• Injection site reactions (if injectable form)
• Fatigue
• Hot flashes
• Dizziness
• Skin darkening (with repeated use)

Drug Interactions

Critical interactions:

• Nitrates – Absolutely contraindicated
• Alpha-blockers – Significant hypotension risk
• Other PDE5 inhibitors – Do not combine
• Riociguat – Contraindicated
• Strong CYP3A4 inhibitors – May increase PDE5 inhibitor levels
• Naltrexone – PT-141 may reduce absorption
• Blood pressure medications – May have unpredictable effects
• Grapefruit/grapefruit juice – Avoid

Dosing Limitations

• Do not use more than once in 24 hours
• Do not exceed 8 doses per month (to minimize skin pigmentation risk from PT-141)
• Sexual stimulation is required for the PDE5 inhibitor components to work
• Allow adequate time before sexual activity for all components to take effect

Special Considerations

Pregnancy and Breastfeeding: Triple Powered should not be used by women who are pregnant or may become pregnant. PT-141 may harm an unborn baby. Use effective contraception. Do not use while breastfeeding.

Not for Women: While PT-141 alone is FDA-approved for premenopausal women with HSDD, Triple Powered is formulated for men treating erectile dysfunction.

Storage

Store according to pharmacy instructions. Protect from light and moisture. Keep refrigerated if directed. Keep out of reach of children.

When to Seek Emergency Care

Get immediate medical help for:

• Chest pain or tightness
• An erection lasting more than 4 hours
• Sudden vision loss or severe vision changes
• Sudden hearing loss
• Severe nausea or vomiting
• Severe dizziness or fainting
• Signs of allergic reaction (difficulty breathing, swelling, severe rash)
• Blood pressure symptoms lasting more than 12 hours

This is a compounded medication not FDA-approved. The combination of these ingredients has not been studied in controlled clinical trials. Use only under healthcare provider supervision.