TESTOSTERONE- testosterone gel, metered
Actavis Pharma, Inc.
Testosterone (tes-TOS-te-rone) CIII
Read this Medication Guide before you start using testosterone gel 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 your treatment.
What is the most important information I should know about testosterone gel?
1. Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like testosterone gel.
Signs and symptoms of early puberty in a child may include:
2. Testosterone gel can transfer from your body to others. Women and children should avoid contact with the unwashed or unclothed area where testosterone gel has been applied to your skin.
Stop using testosterone gel 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 testosterone gel.
Signs and symptoms of exposure to testosterone gel in a child may include:
Signs and symptoms of exposure to testosterone gel in women may include:
To lower the risk of transfer of testosterone gel from your body to others, you should follow these important instructions:
What is testosterone gel?
Testosterone gel is a prescription medicine that contains testosterone. Testosterone gel is used to treat adult males who have low or no testosterone due to certain medical conditions.
Your healthcare provider will test your blood before you start taking and while you are taking testosterone gel.
It is not known if testosterone gel is safe or effective to treat men who have low testosterone due to aging.
It is not known if testosterone gel is safe or effective in children younger than 18 years old. Improper use of testosterone gel may affect bone growth in children.
Testosterone gel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your testosterone gel in a safe place to protect it. Never give testosterone gel 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.
Testosterone gel is not meant for use in women.
Who should not use testosterone gel?
Do not use testosterone gel if you:
Women who are pregnant or who may become pregnant should avoid contact with the area of skin where testosterone gel 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 testosterone gel?
Before you use testosterone gel, 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 testosterone gel with certain 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 these 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 testosterone gel?
Applying testosterone gel:
What are the possible side effects of testosterone gel?
See “What is the most important information I should know about testosterone gel?”
Testosterone gel 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 testosterone gel 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 testosterone gel. 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 testosterone gel?
Store testosterone gel at 68° to 77°F (20° to 25°C).
Keep testosterone gel and all medicines out of the reach of children.
General information about testosterone gel
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use testosterone gel for a condition for which it was not prescribed. Do not give testosterone gel 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 testosterone gel. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about testosterone gel that is written for health professionals.
For more information, go to www.actavis.com or call 1-800-272-5525.
What are the ingredients in testosterone topical gel?
Active ingredient: testosterone
Inactive ingredients: carbomer 1382, dehydrated alcohol, isopropyl alcohol, oleic acid, propylene glycol, purified water, trolamine and butylated hydroxytoluene.
This Medication Guide has been approved by the U.S. Food and Drug Administration
Actavis Laboratories UT, Inc.
Salt Lake City, UT 84108 USA
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Rev. A 5/2018