Product Information

Testosterone topical

What is this medicine?

Generic AndroGel (testosterone) is a topical hormone gel. It works by replacing or supplementing the testosterone that is naturally made in the body. Testosterone is a naturally occurring male hormone necessary for many processes in the body. Testosterone is used to treat conditions in men that result from a lack of natural testosterone. Testosterone may also be used for other purposes not listed in this medication guide.

Important information about Testosterone

Testosterone 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, or with a man's skin areas where Testosterone has been applied. If contact does occur, wash with soap and water right away. Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with the medication. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

What should my health care professional know before I take this medicine?

Do not use Testosterone if you are allergic to testosterone patches or gels, or if you have prostate cancer or male breast cancer. To make sure you can safely use Testosterone, tell your doctor if you have any of these other conditions:

• diabetes
• sleep apnea
• chronic breathing problems
• liver disease
• kidney disease
• if you are overweight.

FDA pregnancy category X. Testosterone 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, or with a man's skin areas where the gel has been applied. If contact does occur, wash with soap and water right away. Older men who use AndroGel may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk. Do not use Testosterone on a boy younger than 18 years old.

How should I take this medicine?

Use Testosterone exactly as it was prescribed by your doctor. Do not use in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Testosterone comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Apply the Gel at the same time each day (preferably in the morning) to clean, dry, unbroken skin on the shoulders or upper arms. Open the gel pouch, and squeeze the entire contents onto the palm of your hand. Apply the gel right away and allow it to dry for at least 5 minutes before you dress. Wash your hands with soap and water after applying the gel. Do not apply Testosterone to your penis or your scrotum. It is best to cover treated skin areas with clothing while using AndroGel. This will help prevent getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water. To be sure this medicine is helping your condition, your blood will need to be tested often. Your prostate or liver function may also need to be tested. Visit your doctor regularly. It is important to use Testosterone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the gel as soon as you remember. If it is almost time to apply your next dose, skip the missed dose and apply the medicine at your next regularly scheduled time. Do not use extra gel to make up the missed dose.

What happens if I overdose?

An overdose of AndroGel applied to the skin is not expected to produce life-threatening symptoms. What should I avoid while using AndroGel? Do not apply AndroGel to your penis or your scrotum. Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel. Testosterone gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

What side effects may I notice from this medicine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using AndroGel and call your doctor at once if you have any of these serious side effects:

• problems with urination;
• swelling of your ankles;
• frequent, prolonged;
• bothersome erections;
• nausea;
• stomach pain
• low fever;
• loss of appetite;
• dark urine;
• clay-colored stools;
• jaundice (yellowing of the skin or eyes).

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics. Less serious AndroGel side effects may include:

• breast swelling or tenderness;
• increased acne or hair growth;
• headache, depressed mood;
• changes in your sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What may interact with this medicine?

Before using AndroGel, tell your doctor if you are using any of the following drugs:

• insulin;
• a blood thinner (warfarin, Coumadin, Jantoven);
• a corticosteroid such as methylprednisolone (Medrol), prednisone (Sterapred), and others.

This list is not complete and there may be other drugs that can interact with AndroGel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.