AndroGel Packets

Name: AndroGel Packets

What Is Androgel (Topical Testosterone)?

Androgel is the brand name of a testosterone treatment that's available as a topical gel.

It's used to treat men who have low levels of the hormone testosterone due to medical conditions such as hypogonadism.

Androgel works by restoring normal levels of the hormone testosterone in the body.

Low testosterone levels (low T) can affect muscle mass, strength, sex drive, and mood.

Androgel is used on the upper arms, shoulders, or stomach area. (Another topical testosterone medicine, Axiron, is applied to the armpit area.)

Some men with sensitive skin may tolerate Androgel better because they can rotate the area of application.

Androgel was the first testosterone gel product. It became available in the United States as a prescription medicine in 2000.

According to the manufacturer, a clinical study found that testosterone levels of 82 percent of men who used Androgel for 16 weeks returned to normal, compared with 37 percent of men who used a placebo.

The Food and Drug Administration (FDA) first approved testosterone treatment in 1953. Androgel is marketed by AbbVie Inc.

Androgel Warnings

Androgel includes a black-box warning because its ingredients can transfer to other people.

This can happen if others come in contact with the application area. Women and children, in particular, should avoid contact with Androgel.

The medicine is absorbed through the skin and can cause male physical traits in those who are exposed to it.

Call a doctor right away if a child is exposed to Androgel and experiences:

  • An enlarged penis or clitoris
  • Early development of pubic hair
  • Increased erections or sex drive
  • Aggressive behavior
  • Male pattern baldness

Call a doctor right away if a woman is exposed to Androgel and experiences:

  • Changes in body hair
  • Irregular menstrual periods
  • Acne

Follow the instructions on your product label carefully when using Androgel to avoid accidental contact with others.

Wash the application site well if you think another person will have direct skin-to-skin contact with that area.

Don't use Androgel if you have male breast cancer or prostate cancer.

Older men who use this medicine may have a greater chance of developing an enlarged prostate or cancer. Talk to your doctor if this is a concern.

This drug shouldn't be given to anyone younger than 18.

Androgel may increase your risk of developing a dangerous blood clot, which can lead to a heart attack or stroke. Talk to your doctor about this risk.

Keep all appointments with your healthcare provider and laboratory when using Androgel. Your doctor will want to perform regular blood tests to monitor your body's response to the drug.

Testosterone medicines such as Androgel are considered controlled drugs.

They should be kept in a secure location away from other people. Never share this drug with another person.

Before using Androgel, tell your doctor if you have, or have ever had:

  • Cancer
  • An enlarged prostate or problems with urination
  • Diabetes
  • Heart disease or a heart attack
  • A stroke
  • Blood clots
  • Kidney or liver disease
  • Sleep apnea (a condition in which breathing stops during sleep)

Androgel may be flammable. Don't smoke or go near an open flame until the medicine is completely dry on your body.

Pregnancy and Androgel

Androgel can cause birth defects. Pregnant women shouldn't use this medicine and all women should avoid any contact with Androgel.

If contact does occur, wash the affected area immediately with soap and water.

Androgel can also pass into breast milk and harm a breastfeeding baby.

Androgel Interactions

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

  • A blood thinner such as Coumadin (warfarin)
  • A steroid such as Medrol (methylprednisolone), Sterapred (prednisone), or others
  • Insulin

What is AndroGel Packets (testosterone topical)?

Testosterone is a naturally occurring male hormone necessary for many processes in the body.

Testosterone topical (for the skin) is used to treat conditions in men that result from a lack of natural testosterone.

Testosterone will not enhance athletic performance and should not be used for that purpose.

Testosterone topical may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using AndroGel Packets (testosterone topical)?

You should not use this medicine if you are allergic to testosterone patches or gels, or if you have;

  • prostate cancer; or

  • male breast cancer.

To make sure testosterone is safe for you, tell your doctor if you have ever had:

  • cancer;

  • enlarged prostate, urination problems;

  • sleep apnea (breathing stops during sleep);

  • heart disease, heart attack, or stroke;

  • a blood clot;

  • diabetes; or

  • liver disease or kidney disease.

Older men who use testosterone topical may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk.

This medicine should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone topical patches or gels, or with a man's skin areas where a patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away.

Do not use testosterone topical on anyone younger than 18 years old.

The testosterone transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

What happens if I miss a dose?

Apply the gel or skin patch as soon as you remember. Skip the missed dose if it is almost time to apply your next dose. Do not use extra patches or gel to make up the missed dose.

If a skin patch falls off in the morning, reapply it. If it does not stick well, apply a new patch. If the patch falls off in the afternoon and cannot be reapplied, wait until your regular patch replacement time in the evening before putting on a new patch.

What other drugs will affect AndroGel Packets (testosterone topical)?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • insulin;

  • a blood thinner (warfarin, Coumadin, Jantoven); or

  • steroid medicine (methylprednisolone, prednisone, and others.)

This list is not complete. Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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