Medications to Support Hormonal Health in Men

Patient Drug Information
Medications to Support Hormonal Health in Men
MPG-TESTOSTERONE-PIB-OHAZ01

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

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.

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

• Enclomiphene Citrate is a selective estrogen receptor modulator (SERM) used to increase testicular production of testosterone in men.
  • Enclomiphene’s most common side effects are mood changes, headache, nausea and flushing.
• Tadalafil is a phosphodiesterase-5 (PDE-5) inhibitor used to treat sexual dysfunction in men.
  • Tadalafil’s most common side effects when taken daily are headaches, upset stomach, nasal congestion, nausea, dizziness, back pain, and warmth or redness in your face, neck, arms or upper chest.
  • Serious adverse medical events can occur while taking tadalafil that may have permanent effects. Seek emergency medical care if you develop a painful erection or an erection that lasts longer than 4 hours while taking tadalafil. If this is not treated right away, it may lead to lasting sex problems and you may not regain normal organ function. You should also seek emergency medical care if you notice sudden loss of vision or hearing while taking tadalafil.
• Vitamin B6 (Pyridoxine hydrochloride) is a B 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 

• Take as prescribed by your provider.
• This medication may be prescribed to be taken once daily or every other day. Refer to your prescription label for your prescriber’s directions and recommended dose and frequency.
• Take with or without food at the same time every day

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. Under certain circumstances a prescription drug’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity.
• Keep out of reach of children.

Precautions and contraindications

Tablets containing Enclomiphene:

• Do not take this medication if you are allergic to any of its components or allergic to clomiphene. Signs and symptoms of an allergic reaction may include: rashes; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Do not take this medication if you currently have or have had a hormone-sensitive cancer, such as prostate cancer or breast cancer.
• Do not take this medication if you have a history of blood clots such as deep vein thrombosis (DVT) or a pulmonary embolism (PE).
• Do not take this medication if you have active liver disease or liver dysfunction.
• Prior to starting this medication, talk to your provider if you have:
  • Severe obstructive sleep apnea.
  • Severe liver or kidney disease
  • A history of mental health conditions, such as uncontrolled bipolar disorder or psychosis.
  • Adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.
• Do not take this medication while taking testosterone therapy or anabolic steroids.

  Tablets containing Tadalafil:

• Do not take this medication if you are allergic to any of its components. Signs and symptoms of an allergic reaction may include: rashes; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Seek medical attention right away if you have a sudden decrease or loss of eyesight or hearing.
• 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. Recreational nitrates may be known as “rush” or “poppers” and should also be avoided.
• If the following apply to you, do not take this medication without consulting with your provider:
  • You’re currently using recreational drugs like cocaine or methamphetamine.
  • You’re receiving injections or suppositories for erectile dysfunction (ED) or are taking other forms of ED medications (i.e. Cialis, Viagra)
  • You have had a heart attack in the past 2–8 weeks
  • You have uncontrolled high blood pressure.
  • You have serious heart failure (stage 3 or 4).
  • You have poorly controlled atrial fibrillation.
  • You have severe liver or kidney disease.
  • You have had a stroke in the past 6 months.
  • You have severe bleeding problems.
  • You regularly consume grapefruit or grapefruit juice.
• Taking tadalafil at the same time as medications called alpha-blockers can lower your blood pressure. 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 you have ever experienced hearing or vision loss after taking ED medication or clomiphene in the past.
• 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. 

Tablets containing Vitamin B6, Vitamin B12, L-Arginine and Zinc Sulfate

• Do not take this medication if you are allergic to cyanocobalamin (vitamin B12), Pyridoxine (vitamin B6), L- Arginine, or Zinc Sulfate.  Signs and symptoms of an allergic reaction may include: rashes; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• 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

• Do not flush unused medication down the toilet or pour in the sink or drain.
• Dispose according to local regulations.
• Check with your local pharmacy for assigned safe medication disposal locations.

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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