Compounded Oral Tablet (ED and/or PE)

Patient Drug Information
Compounded Oral Tablet
For the treatment of erectile dysfunction (ED) and/or premature ejaculation (PE)

About your medication: Written information about this prescription has been provided for you. Please read this information before you take this medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions.

Your compounded medication may not include all of the ingredients below. Your compounded medication’s ingredients were customized to your prescription. Please refer to your medication label to determine which of the following ingredients are contained in your medication. 

This is a compounded prescription product and has not been approved by the FDA. The FDA does not verify the safety, effectiveness, or quality of compounded drugs.

Important Information: 
This should only be taken by the patient whose name appears on the prescription label.

• Active Ingredients and Common Side Effects
  Your tablet may contain one or more of the following active ingredients: Sildenafil, Tadalafil, Vardenafil, Fluoxetine, Rosuvastatin, Atorvastatin,, Vitamin B6, Vitamin B12, L-Arginine, or Zinc.

• Sildenafil (Sildenafil citrate), tadalafil, and vardenafil (vardenafil hydrochloride) are phosphodiesterase-5 (PDE-5) inhibitors used to treat erectile dysfunction in men.
  • Sildenafil’s most common side effects are headaches, flushing and upset stomach. Sildenafil can also sometimes cause mild vision disturbances such as color-tinged or blurred vision with increased light sensitivity.
  • Tadalafil’s most common side effects when taken as needed before sex are headache, upset stomach and back pain.
  • Tadalafil’s most common side effects when taken daily are headaches, upset stomach and nasal congestion.
  • Vardenafil’s most common side effects are headaches, flushing, and stuffy or runny nose.
• Fluoxetine (Fluoxetine hydrochloride) is a selective serotonin reuptake inhibitor used off-label to treat premature ejaculation.
  • Fluoxetine’s most common side effects are dizziness, drowsiness, trouble sleeping, dry mouth, diarrhea, and nausea.
• Rosuvastatin (Rosuvastatin calcium) and atorvastatin (Atorvastatin calcium) are HMG-CoA reductase inhibitors used to reduce bad cholesterol and reduce cardiovascular risk.
  • Rosuvastatin’s most common side effects are muscle pain or weakness, headache, and upset stomach.
  • Atorvastatin’s most common side effects are joint pain, diarrhea, nose or throat irritation.
• Vitamin B6 (Pyridoxine hydrochloride) is a vitamin used to supplement the diet.
  • Vitamin B6 is generally well tolerated, but when taken in excess, side effects may include extreme sensitivity to sunlight, nausea, heartburn, and painful skin patches.
• Vitamin B12 (Cyanocobalamin) is a B vitamin used to supplement the diet.
  • Vitamin B12 is generally well tolerated, with no significant side effects when taken orally.
• L-Arginine is an amino acid used to supplement the diet.
  • L-arginine is generally well tolerated, but when taken in excess, side effects may include abdominal pain, bloating, nausea, diarrhea, headache, insomnia, or flushing.
• Zinc (Zinc sulfate monohydrate) is a mineral used to supplement the diet.
  • Zinc is generally well tolerated, but when taken in excess, side effects may include indigestion, diarrhea, headache, nausea, or throwing up.

• Directions for Use 
  Refer to your prescription label for your prescriber’s directions and recommended dose and frequency.
  • For Chewable tablets or gummies: Chew and swallow, or swallow whole.
  • For Swallowable tablets: Swallow only, do not chew.
  • For Daily: Try to take at the same time each day.
  • For As Needed: Take prior to sexual activity as directed by your treating provider.
    
     

• Storage
  • Store your compounded medication at room temperature between 68°F to 77°F (20°C to 25°C) in the packaging provided by the pharmacy until you need it. Keep out of reach of children.
  • Under certain circumstances a prescription drug’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity.

• Precautions and Contraindications
  • Do not take this medication if you are allergic to any of its components.
  • Due to potential for a dangerous drop in blood pressure, sildenafil, tadalafil, and vardenafil must not be taken with nitrates or nitrate medications. Examples of nitrates include nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate, sodium nitroprusside, amyl nitrate, creatine nitrate, and arginine nitrate. Take extra precautions when consuming pre-workout supplements that may contain beet root extract and other organic nitrates. Before taking a supplement, check with your pharmacist or healthcare provider to ensure the product does not contain nitrates.
  • Tell your prescriber if you are on an alpha-blocker medication prior to starting this medication. These medications include but are not limited to doxazosin, prazosin, terazosin, tamsulosin, alfuzosin ER, silodosin, and phenoxybenzamine.
  • Do not take this medication if on guanylate cyclase stimulators such as riociguat.
  • Do not take compounded medications containing vardenafil if you have a heart condition known as Long QT Syndrome. Vardenafil can cause fatal arrhythmias in patients with Long QT Syndrome.
  • Do not take compounded medications containing rosuvastatin or atorvastatin if you have liver disease or raised liver enzymes.
  • Do not take this medication if your prescriber or other healthcare provider has advised you that the cardiovascular activity of sex is not safe for you.
  • Do not take this medication if you have ever experienced hearing or vision loss after taking ED medication in the past.
  • Taking fluoxetine may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.
  • Drinking alcoholic beverages can increase your chance of headache, dizziness, fast heart rate, low BP and liver problems when taking fluoxetine.

• Taking very high doses of zinc is likely unsafe and might cause stomach pain, vomiting, and many other problems. Do not take this compounded tablet if you are taking other medications or supplements that include zinc.

• Missed Dose
  • If you miss a dose of a daily medication, take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for the missed dose. Do not take more than the maximum allowable dose indicated on your prescription in a 24 hour period. Check your prescription label for the correct dose prescribed by your medical provider. 
     
• Disposal of Medications
  • This medication may contain a hazardous drug. Do not flush unused medication down the toilet or pour in the sink or drain. Dispose according to local regulations.

• Additional Information
  • Our pharmacy may use imprinted codes stamped into your tablet for pill identification purposes. These codes do not align with generic drug imprinting defined by the FDA. If you have questions about your compounded tablet’s unique imprint code, please contact the pharmacy using the number on the label of your prescription product.

Questions
This written information may not cover all possible information. If you have any questions, talk to your pharmacist or medical provider.

A local or a toll-free telephone service is available, staffed by registered pharmacists, to answer questions about your medication. You can find the number for the pharmacy on the label of your prescription product.

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