What is Go Long?

Go Long is a compounded medication combining two active ingredients: paroxetine and tadalafil. It is intended only for men 18 years and older for the treatment of premature ejaculation.

Important: Go Long is a compounded medication. Although its ingredients have been FDA-approved for other uses, Go Long itself is NOT FDA-approved and has not been reviewed by the FDA for safety, effectiveness, or quality for any use.

• Paroxetine is typically used to treat depression and anxiety disorders. In Go Long, it is used "off-label" (meaning for a purpose not officially approved by the FDA) to help with premature ejaculation.
• Tadalafil is FDA-approved to treat erectile dysfunction and enlarged prostate symptoms.

Note: This summary does not contain all possible safety information. It is not a substitute for advice from your healthcare provider. Always talk to your doctor or pharmacist before taking this medication.

Who Should NOT Take Go Long

Do not take Go Long if you:

• Are currently taking or have taken MAO inhibitors (a type of antidepressant) within the last 14 days
• Are taking pimozide or thioridazine (antipsychotic medications)
• Are taking any form of nitrates (often prescribed for chest pain/angina, such as nitroglycerin)
• Have had a serious allergic reaction to paroxetine or tadalafil in the past

Important Warnings

Heart and Blood Pressure Concerns

• Do not take Go Long if sexual activity is risky for your heart. Talk to your doctor if you have heart problems.
• Taking Go Long with alpha-blockers (medications for high blood pressure or prostate issues), blood pressure medications, or more than 5 alcoholic drinks can cause a dangerous drop in blood pressure.

Mental Health Warnings

SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants like paroxetine may increase the risk of suicidal thoughts and behaviors, especially in young adults. Watch for new or worsening depression, unusual mood changes, or thoughts of self-harm. Contact your doctor immediately if you experience these symptoms.

Serotonin Syndrome

Taking Go Long with other medications that affect serotonin (such as other antidepressants, migraine medications called triptans, or certain pain medications) can cause a serious condition called serotonin syndrome. Symptoms include agitation, hallucinations, rapid heartbeat, fever, muscle stiffness, and loss of coordination. Seek medical help immediately if you experience these symptoms.

Vision and Hearing

• Stop taking Go Long and get medical help right away if you experience sudden vision loss in one or both eyes.
• Stop taking Go Long and get medical help right away if you experience sudden hearing loss or ringing in your ears.

Prolonged Erection

• Seek emergency medical care if you have an erection lasting more than 4 hours. This condition (priapism) can cause permanent damage if not treated promptly.

Other Precautions

Talk to your doctor before taking Go Long if you have:

• A history of bipolar disorder or mania
• Seizures or epilepsy
• Glaucoma or eye pressure problems
• A history of priapism (prolonged erections)
• A previous episode of sudden vision loss (NAION)
• Liver or kidney problems
• A bleeding disorder or if you take blood thinners

Cannabis Warning

Avoid concurrent use of cannabis products, as they may slow the breakdown of your
medication and increase side effects

Increased Bleeding Risk

Go Long may increase your risk of bleeding, especially if you also take:

• Aspirin Ibuprofen, naproxen, or other NSAIDs (nonsteroidal anti-inflammatory drugs)
• Blood thinners like warfarin
• Other medications that affect blood clotting

Drug Interactions

Tell your doctor about all medications you take, especially:

Common Side Effects

From Paroxetine:

• Nausea
• Dry mouth
• Drowsiness or fatigue
• Dizziness
• Constipation or diarrhea
• Decreased appetite
• Sweating
• Trouble sleeping
• Nervousness
• Tremor
• Sexual difficulties (changes in desire, difficulty with orgasm)

From Tadalafil:

• Headache
• Indigestion or upset stomach
• Back pain
• Muscle aches
• Stuffy nose
• Flushing (warmth or redness in face/neck)
• Pain in arms or legs

Special Populations

This medication is NOT for:

• Women
• Anyone under 18 years old
• Pregnant or breastfeeding individuals (can cause harm to babies)

Use with caution if you have:

• Liver problems: Dose adjustment may be needed; not recommended for severe liver disease
• Kidney problems: Dose adjustment may be needed; limited use for severe kidney disease

Reporting Side Effects

If you experience any serious or unexpected side effects, report them to the FDA:

• Phone: 1-800-FDA-1088
• Online: www.fda.gov/medwatch