MEDICATION GUIDE

Testosterone (tes-TOS-te-rone) Topical Solution

for topical use CIII

What is the most important information I should know about testosterone topical solution?

1.      Testosterone topical solution can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where testosterone topical solution has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used testosterone topical solution.

                                                                                                                

 

Children

Signs and symptoms of early puberty in a child when they come in direct contact with testosterone topical solution may include:

Abnormal sexual changes:

•   enlarged penis or clitoris.
•   early growth of hair near the vagina or around the penis (pubic hair).
•   erections or acting out sexual urges (sex drive).

Behavior problems:

•   acting aggressively, behaving in an angry or violent way.

Women 

Signs and symptoms in women when they come in direct contact with testosterone topical solution may include:

•   changes in body hair.
•   an abnormal increase in pimples (acne).

Stop using testosterone topical solution and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have applied testosterone topical solution:

2.       To lower the risk of transfer of testosterone topical solution from your body to others, follow these important instructions:

• Apply testosterone topical solution only to your armpits.
• Wash your hands right away with soap and water after applying testosterone topical solution.
• After the solution has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
• If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
• If a child or woman touches the area where you have applied testosterone topical solution, that area on the child or woman should be washed well with soap and water right away

What is testosterone topical solution?

• Testosterone topical solution is a prescription medicine that contains testosterone. Testosterone topical solution 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 and while you are using testosterone topical solution.
  • It is not known if testosterone topical solution is safe or effective to treat men who have low testosterone due to aging.
  • It is not known if testosterone topical solution is safe and effective in children younger than 18 years old. Improper use of testosterone topical solution may affect bone growth in children.

•   Testosterone topical solution is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your testosterone topical solution in a safe place to protect it. Never give testosterone topical solution 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.
•   Testosterone topical solution is not meant for use in women.

Do not use testosterone topical solution if you:

• have breast cancer.
• have or might have prostate cancer.
• are pregnant or may become pregnant or are breastfeeding. Testosterone topical solution may harm your unborn or breastfeeding baby.

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

Before using testosterone topical solution, tell your healthcare provider about all of your medical conditions, including if you:

• have breast cancer.
• have or might have prostate cancer.
• have urinary problems due to an enlarged prostate.
• have heart problems.
• have kidney or liver problems.
• have problems breathing while you sleep (sleep apnea).

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

Using testosterone topical solution with other medicines can affect each other.

Especially tell your healthcare provider if you take:

• insulin
• medicines that decrease blood clotting (blood thinners)
• corticosteroids

How should I use testosterone topical solution?

•   See the detailed Instructions for Use for information about how to use testosterone topical solution at the end of this Medication Guide.
•   Testosterone topical solution comes in a metered-dose pump or twist actuated dispenser. Make sure you have the right pump or dispenser that is prescribed for you.
•   It is important that you apply testosterone topical solution exactly as your healthcare provider tells you to.
•   Your healthcare provider may change your testosterone topical solution dose. Do not change your testosterone topical solution dose without talking to your healthcare provider.
•   Apply testosterone topical solution at about the same time each morning. Testosterone topical solution should be applied after showering or bathing.

What are the possible side effects of testosterone topical solution?

Testosterone topical solution can cause serious side effects including:

See also "What is the most important information I should know about testosterone topical solution?"

• If you already have an enlarged prostate, your symptoms can get worse while using testosterone topical solution. This can include:
  • increased urination at night.
  • trouble starting your urine stream.
  • having to pass urine many times during the day.
  • having an urge to go to the bathroom right away.
  • having a urine accident.
  • being unable to pass urine or weak urine flow.
• Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use testosterone topical solution.
• Blood clots in the legs or lungs . Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Possible increased risk of heart attack or stroke.
• In large doses testosterone topical solution may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure.
• Enlarged or painful breasts.
• Have problems breathing while you sleep (sleep apnea).

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

The most common side effects of testosterone topical solution include:

• skin redness or irritation where testosterone topical solution is applied
• increased red blood cell count
• headache
• diarrhea
• vomiting
• increase in blood level of Prostate Specific Antigen (a test used to screen for prostate cancer)

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 topical solution. 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.

General information about the safe and effective use of testosterone topical solution

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

You can ask your pharmacist or healthcare provider for information about testosterone topical solution that is written for health professionals.

What are the ingredients in testosterone topical solution?

Active ingredient: testosterone, USP.

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

The bottle and the applicator cup are not made with natural rubber latex.

For more information call 1-866-604-3268.

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

Manufactured by:

Cipla Limited,

Verna Goa, India.

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Revised: 2/2020