⚠️ Important Safety Information for Sildenafil

Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). One Peak Performance gummy can contain either sildenafil 50mg or tadalafil 40mg or both sildenafil 50mg and tadalafil 50mg as a compounded drug.

Compounded drugs are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review.

Who should not use sildenafil?

Do not use sildenafil if:

* You are taking a class of medications called nitric oxide donors, including isosorbide dinitrate (Isordil), isosorbide mononitrate (Monoket), or nitroglycerine (Nitromist, Nitro-Dur, etc.) Combining sildenafil with nitrates can cause dangerously low blood pressure.

* You are taking a class of medications called soluble guanylate cyclase (GC) stimulators, such as riociguat. Sildenafil, when combined with these medications, can cause dangerously low blood pressure. 

* You have a known allergy to the active ingredients (sildenafil and tadalafil) or inactive ingredients in Peak Performance gummies including Brilliant Blue FCF, Yellow Dye No. 5, Red Dye No. 40, or coconut oil.

Do not mix Sildenafil with medications including:

Nitrates, alpha-blockers, and antihypertensives: When these medications are taken with sildenafil, a sudden drop in blood pressure can occur.

CYP3A4 inhibitors, such as ritonavir, ketoconazole, itraconazole, and erythromycin: These medications increase the amount of sildenafil in your blood stream, which can cause a sudden drop in blood pressure as well as a dangerously prolonged erection.

Alcohol: Drinking large amounts of alcohol (>5 units) when using this product can result in a sudden drop in blood pressure.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You should carefully monitor for these side effects, especially at the beginning of treatment.

* Cardiac risk of sexual activity: ED medication should not be used by men for whom sexual activity is not advised because of their underlying cardiovascular status. 

* Combination with other PDE-5 inhibitors: This compounded medication contains two prescription PDE-5 inhibitors, sildenafil and tadalafil. Monitor for signs of severely low blood pressure, such as dizziness, fainting, or prolonged erection. Do not take this medication more than once in any 24-hour period or within 24 hours of taking any other ED medications or products that contain tadalafil or sildenafil.

* Prolonged erections: Seek immediate emergency treatment for an erection lasting more than 4 hours.

* Effects on the eye: Seek medical care and stop medication if you experience a sudden loss of vision in one or both eyes. Sudden loss of vision could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).

* Sudden hearing loss: Stop medication and seek prompt medical attention if you experience a sudden decrease or loss of hearing, which may be accompanied by ringing in the ears.  

* Taking this medication in combination with alpha-blockers or other blood pressure-lowering drugs: If you are taking a medication to lower your blood pressure or taking an alpha-blocker, sildenafil may increase the blood-pressure-lowering effect, leading to a sudden drop in blood pressure. When starting sildenafil, monitor carefully for signs of excessively low blood pressure, including dizziness, lightheadedness, or fainting.

* Taking this medication in combination with ritonavir: If you are taking a medication called ritonavir at the same time as sildenafil, ritonavir can increase the amount of sildenafil in your system. There may be an increased risk of  dangerously low blood pressure, fainting, and prolonged erection.

* Effects on bleeding: Sildenafil has no effect on bleeding time when taken alone or with aspirin; however, there have been reports of bleeding with the use of sildenafil. Tell your provider if you have a history of bleeding disorder or ulcers.

* Alcohol: Drinking large amounts of alcohol (>5 units) with sildenafil can increase the risk of a sudden drop in blood pressure.

* Sexually transmitted infections: Sildenafil does not protect against sexually transmitted diseases. Use safe sex practices.

⚠️ Important Safety Information for Tadalafil

Tadalafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). One Peak Performance gummy can contain either sildenafil 50mg or tadalafil 40mg or both sildenafil 50mg and tadalafil 50mg as a compounded drug.

Compounded drugs are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review.

Who should not use tadalafil?

Do not use tadalafil if:

* You are taking a class of medications called nitric oxide donors, including isosorbide dinitrate (Isordil), isosorbide mononitrate (Monoket), or nitroglycerine (Nitromist, Nitro-Dur, etc.) Combining tadalafil with nitrates can cause dangerously low blood pressure.

* You are taking a class of medications called soluble guanylate cyclase (GC) stimulators, such as riociguat. Tadalafil, when combined with these medications, can cause dangerously low blood pressure. 

* You have a known allergy to the active ingredients (sildenafil and tadalafil) or inactive ingredients in Sparks, including Brilliant Blue FCF, Yellow Dye No. 5, Red Dye No. 40. Do not use Sparks if you have coconut allergy, since coconut oil is used during processing. 

Do not mix Tadalafil with medications including:

Nitrates, alpha-blockers, and antihypertensives: When these medications are taken with sildenafil, a sudden drop in blood pressure can occur.

CYP3A4 inhibitors, such as ritonavir, ketoconazole, itraconazole, and erythromycin: These medications increase the amount of sildenafil in your blood stream, which can cause a sudden drop in blood pressure as well as a dangerously prolonged erection.

Alcohol: Drinking large amounts of alcohol (>5 units) when using this product can result in a sudden drop in blood pressure.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment.

* Cardiac risk of sexual activity: ED medication should not be used by men for whom sexual activity is not advised because of their underlying cardiovascular status. 

* Combination with other PDE-5 inhibitors: This compounded medication contains two prescription PDE-5 inhibitors, sildenafil and tadalafil. Monitor for signs of severely low blood pressure, such as dizziness, fainting, or prolonged erection. Do not take this medication more than once in a 24-hour period or within 24 hours of any other ED medications or products that contain tadalafil or sildenafil.

* Prolonged erections: Seek immediate emergency treatment for an erection lasting more than 4 hours.

* Effects on the eye: Seek medical care and stop medication if you experience a sudden loss of vision in one or both eyes. Sudden loss of vision could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).

* Sudden hearing loss: Stop medication and seek prompt medical attention if you experience a sudden decrease or loss of hearing, which may be accompanied by ringing in the ears.  

* Co-administering with alpha-blockers or other blood pressure-lowering drugs: If you are taking a medication to lower your blood pressure or taking an alpha-blocker, tadalafil may increase the blood-pressure-lowering effect, leading to a sudden drop in blood pressure. When starting tadalafil, monitor carefully for signs of excessively low blood pressure, including dizziness, lightheadedness, or fainting.

* Kidney impairment: Talk to your provider about the appropriate dose of tadalafil if you have kidney impairment. 

* Liver impairment: Talk to your provider about the appropriate dose of tadalafil if you have liver impairment. 

* Alcohol: Drinking large amounts of alcohol (>5 units) with tadalafil can increase the risk of a sudden drop in blood pressure.

* Co-administering with CYP3A4 inhibitors: Talk to your provider about the appropriate dose of tadalafil if you are taking potent inhibitors of CYP3A such as ritonavir, ketoconazole, and itraconazole.

* Effects on bleeding: In studies, tadalafil did not affect bleeding time when taken alone or with aspirin. Tell your provider if you have a bleeding disorder or ulcers.

* Sexually transmitted infections: Tadalafil does not protect against sexually transmitted diseases. Use safe sex practices.