AXIRON  - testosterone  solution 
Physicians Total Care, Inc.

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Medication Guide

AXIRON® (AXE-e-RON) CIII

(testosterone) topical solution

Read this Medication Guide before you start using AXIRON and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about AXIRON?

AXIRON can transfer from your body to others. This can happen if other people come into contact with the area where the AXIRON was applied.

Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through skin to skin contact with men using topical testosterone products like AXIRON.

Stop using AXIRON and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to AXIRON:

Signs and symptoms in children may include:

Signs and symptoms in women may include:

What is AXIRON?

AXIRON is a prescription medicine that contains testosterone. AXIRON is used to treat adult males who have low or no testosterone.

Your healthcare provider will test your blood before you start and while you are taking AXIRON.

It is not known if AXIRON is safe and effective in children younger than 18 years old. Improper use of AXIRON may affect bone growth in children.

AXIRON is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your AXIRON in a safe place to protect it. Never give AXIRON to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.

AXIRON is not meant for use in women.

Who should not use AXIRON?

Do not use AXIRON if you:

Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AXIRON has been applied.

Talk to your healthcare provider before taking this medicine if you have any of the above conditions.

What should I tell my healthcare provider before using AXIRON?

Before you use AXIRON, tell your healthcare provider if you:

Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using AXIRON with other medicines can affect each other.

Especially tell your healthcare provider if you take:

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of all of your medicines if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use AXIRON?

Applying Axiron
Figure 1

AXIRON Figure 1

  • Before using a new bottle of AXIRON for the first time, you will need to prime the pump. To prime the AXIRON pump gently push down on the pump 3 times. Do not use any AXIRON that came out while priming. Wash it down the sink to avoid accidental exposure to others. Your AXIRON pump is now ready to use.
  • Use AXIRON exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you the dose of AXIRON that is right for you. Apply your dose correctly by following the application instructions in the table below.
Find Your Dose as Prescribed by Your Doctor Each application equals 1 depression of the pump.
30 mg Apply 1 application once to one armpit only (left OR right).
60 mg Apply 2 applications: one to the left armpit and then one to the right armpit.
90 mg Apply 3 applications: one to the left and one to the right armpit, wait for the product to dry, and then apply again one to the left OR right armpit.
120 mg Apply 4 applications: one to the left and one to the right armpit, wait for the product to dry, and then apply again one to the left AND one to the right armpit.
Figure 2

Figure 2

  • Remove the cap and the applicator cup from the pump. Then, position the nozzle over the applicator cup and depress the pump gently (see Figure 2).
Figure 3

Figure 3

  • To apply the AXIRON solution, keep the applicator upright, place it up into the armpit application site and wipe steadily down and up (see Figure 3).
  • If AXIRON drips or runs, wipe it back up with the applicator cup. Do not rub in the solution with your fingers or hand once it has been applied.

What are the possible side effects of AXIRON?

See also “What is the most important information I should know about AXIRON?”

AXIRON can cause serious side effects including:

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of AXIRON include:

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of AXIRON. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store AXIRON?

Store AXIRON at 15°C to 30°C (59°F to 86°F)

When it is time to throw away the bottle, safely throw away all parts of the AXIRON dispenser including bottle applicator cup and cap. Be careful to prevent accidental exposure of children or pets.

Keep AXIRON away from fire.

General information about AXIRON

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AXIRON for a condition for which it was not prescribed. Do not give AXIRON to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about AXIRON. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about AXIRON that is written for health professionals.

For more information, go to www.axiron.com or call 1-800-545-5979.

What are the ingredients in AXIRON?

Active ingredient: testosterone.

Inactive ingredients: ethanol, isopropyl alcohol, octisalate, and povidone.

The bottle or applicator cup does not contain latex.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Literature issued November 2010

Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA

PV 8161 AMP

Revised: 11/2013
 
Physicians Total Care, Inc.