Compounded Oral Combination Tablet (ED and Hair Loss)

Patient Drug Information
Compounded Oral Combination Tablet
For the treatment of erectile dysfunction (ED) and hair loss

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
  • Tadalafil is a phosphodiesterase-5 (PDE-5) inhibitor used to treat sexual dysfunction and/or prostate enlargement in men.
    • Tadalafil’s most common side effects when taken daily are headaches, upset stomach and nasal congestion.
  • Finasteride is a 5 alpha-reductase inhibitor used to treat hair loss and prostate enlargement in men.
    • Finasteride is generally well tolerated, but rare side effects include sexual dysfunction, breast tenderness or enlargement, and rash.
  • Minoxidil is a blood pressure medication used off-label orally at low doses to treat hair loss.
    • The most common side effect of low dose oral minoxidil is hypertrichosis, or excessive hair growth on the face or body. Other side effects of low dose oral minoxidil include, but are not limited to, the following: lightheadedness, headaches, palpitations, leg swelling, swelling around the eyes, nausea and vomiting, and rash. Low dose oral minoxidil may cause increased hair shedding with initial use. This is an expected side effect that will improve with continued minoxidil use.
    • Minoxidil may take 6-12 months until the full effect is realized. If taking minoxidil at the prescribed doses does not improve your hair growth, contact your medical provider.
  • Biotin is a B Vitamin used to supplement the diet.
    • Biotin is generally well tolerated, but when taken in excess, side effects may include stomachache, trouble sleeping, excessive thirst, skin rashes, digestive upset, problems with insulin release, and kidney problems. Taking more than 5 milligrams a day can cause false lab results.
  • 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.
  • Vitamin D3 (Cholecalciferol) is a vitamin used to supplement the diet.
    • Vitamin D is generally well tolerated, but when taken in excess, side effects may include weakness, dry mouth, nausea and vomiting.
  • L-theanine is an amino acid used to supplement the diet.
    • L-Theanine is generally well tolerated, but rarely you may experience headaches or feeling drowsy.

• Directions for Use
  • Take one tablet once daily with or without food
  • Chewable tablets: Chew and swallow one tablet by mouth once daily with or without food.
  • Swallowable tablets: Take and swallow one tablet by mouth once daily with or without food.

• 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, tadalafil 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 doctor if you are on an alpha-blocker medication prior to starting tadalafil. These medications include but are not limited to doxazosin, prazosin, terazosin, tamsulosin, alfuzosin ER, silodosin, and phenoxybenzamine.
  • Do not take tadalafil if on guanylate cyclase stimulators such as riociguat.
  • Pregnant women or women of childbearing potential should not handle broken or crushed tablets,  as finasteride may be absorbed through the skin. Finasteride should not be taken by women who are pregnant or breastfeeding. Not for use in females or children.
  • PSA levels (a lab test) may be decreased when taking finasteride which can affect the performance of PSA as a screening test for prostate cancer. If you are undergoing PSA testing as part of prostate cancer screening, inform the provider ordering the PSA test that you are taking finasteride so that they can properly interpret your PSA test.
  • Finasteride may be linked to depression and suicidal thoughts or tendencies in younger patients undergoing treatment for alopecia. If you notice any of these symptoms, reach out to your healthcare provider right away.
  • Be sure to notify all your healthcare providers about any new medications you've been prescribed.
  • Do not take this medication if you have ever experienced hearing or vision loss after taking ED medication in the past.
  • 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.
  • Tell your provider if you have had a recent heart attack or history of cardiovascular conditions before starting this medication.
  • Minoxidil may cause changes to your EKG; tell your doctor prior to an EKG if you are taking oral minoxidil.
  • Minoxidil is contraindicated for patients diagnosed with an adrenal tumor called pheochromocytoma.
  • High amounts of biotin can also create false positives in laboratory tests, including specific tests to aid in the diagnosis of a heart attack. Stop taking this medication and consult with your healthcare provider if you experience chest pain, exertional shortness of breath, or any other of symptoms concerning for a heart problem.
  • Do not take Vitamin D if you have high calcium levels.

• Missed Dose
  • If you miss a dose, 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. Check your prescription label for the correct dose prescribed by your medical provider.

• 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 a registered pharmacist, 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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