Fortesta

Generic Name: testosterone topical (tes TOS ter one TOP i kal)
Brand Names: Androderm, AndroGel, Axiron, FIRST-Testosterone, FIRST-Testosterone MC, Fortesta, Testim

What is Fortesta?

Fortesta Gel is a prescription medicine that contains testosterone.

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

Fortesta is used to treat conditions in men that result from a lack of natural testosterone.

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

Important information

Fortesta 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 Fortesta gel has been applied. If contact does occur, wash with soap and water right away. Topical Fortesta testosterone gel 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.

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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.

Before using Fortesta

Do not use Fortesta if you are allergic to testosterone, or if you have prostate cancer or male breast cancer.

To make sure you can safely use Fortesta, tell your doctor if you have any of these other conditions:

  • diabetes;

  • sleep apnea or chronic breathing problems;

  • liver disease or kidney disease; or
  • if you are overweight.

FDA pregnancy category X. Fortesta 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 Fortesta gel, or with a man's skin areas where the gel has been applied. If contact does occur, wash with soap and water right away.

See also: Pregnancy and breastfeeding warnings (in more detail)

Older men who use Fortesta may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk. Fortesta gel should not be used on anyone younger than 18 years old.

How should I use Fortesta?

Use Fortesta exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Fortesta comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Before using a new canister of Fortesta gel for the first time, you will need to prime the pump. To prime the pump, gently push down on the pump 8 times. Do not use any Fortesta gel that comes out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others.

Depress the pump to apply the medicine directly on clean, dry, intact skin of the front and inner part of your thighs. Use one finger to gently rub Fortesta gel evenly onto the front and inner part of each thigh. Let the application site dry completely before putting on shorts or pants. Wash your hands right away with soap and water.

Do not apply Fortesta gel to your penis, scrotum, shoulders or upper arms.

It is best to cover treated skin areas with clothing while using Fortesta gel. 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 Fortesta 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.

Use Fortesta regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store Fortesta at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Do not Fortesta gel to your penis, scrotum, shoulders or upper arms.

Avoid swimming, bathing, or showering for at least 2 hours after applying Fortesta testosterone gel.

Fortesta is flammable until dry. Let the Fortesta gel dry before smoking or going near an open flame.

Fortesta side effects

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

  • problems with urination;

  • swelling of your ankles;

  • frequent, prolonged, or bothersome erections; or

  • 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 Fortesta side effects may include:

  • breast swelling or tenderness;

  • increased acne or hair growth;

  • headache, depressed mood; or

  • 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. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Fortesta?

Tell your doctor about all other medicines you use, especially:

  • insulin;

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

  • a steroid such as methylprednisolone (Medrol), prednisone (Sterapred), and others.

This list is not complete and other drugs may interact with Fortesta. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Fortesta.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fortesta only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 12.02. Revision Date: 2012-04-18, 12:24:52 PM.

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