ANDROGEL - testosterone gel
Physicians Total Care, Inc.
AndroGel® (AN DROW JEL) CIII
(testosterone gel) 1%
Read the Medication Guide that comes with AndroGel before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about AndroGel?
1. Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using AndroGel.
Signs and symptoms of early puberty in a child may include:
AndroGel can transfer from your body to others.
2. Women and children should avoid contact with the unwashed or unclothed area where AndroGel has been applied to your skin.
Stop using AndroGel 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 AndroGel.
Signs and symptoms of exposure to AndroGel in children may include:
Signs and symptoms of exposure to AndroGel in women may include:
To lower the risk of transfer of AndroGel from your body to others, you should follow these important instructions:
What is AndroGel?
AndroGel is a prescription medicine that contains testosterone. AndroGel is used to treat adult males who have low or no testosterone.
It is not known if AndroGel is safe or effective in children younger than 18 years old. Improper use of AndroGel may affect bone growth in children.
AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your AndroGel in a safe place to protect it. Never give your AndroGel to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.
AndroGel is not meant for use in women.
Who should not use AndroGel?
Do not use AndroGel if you:
Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel 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 AndroGel?
Before you use AndroGel, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Using AndroGel with certain other medicines can affect each other.
Especially, tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use AndroGel?
Your healthcare provider will test your blood before you start and while you take AndroGel.
What are the possible side effects of AndroGel?
AndroGel can cause serious side effects including:
See “What is the most important information I should know about AndroGel?”
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of AndroGel 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 AndroGel. 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 AndroGel?
Keep AndroGel and all medicines out of the reach of children.
General information about AndroGel
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AndroGel for a condition for which it was not prescribed. Do not give AndroGel 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 AndroGel. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about AndroGel that is written for health professionals.
For more information, go to www.ANDROGEL.com or call 1-800-241-1643.
What are the ingredients in AndroGel?
Active ingredient: testosterone
Inactive ingredients: carbomer 980, ethyl alcohol 67.0%, isopropyl myristate, purified water and sodium hydroxide.
© 2011 Abbott Laboratories
North Chicago, IL 60064, U.S.A.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued Nov 2011