Fortesta Gel

Generic Name: testosterone topical (tes TOS ter one TOP i kal)
Brand Names: Androderm, AndroGel 2.5 g/packet, AndroGel 5 g/packet, AndroGel Packets, AndroGel Pump 1.25 g/actuation, Axiron, FIRST-Testosterone, FIRST-Testosterone MC, Fortesta, Testim, Vogelxo

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

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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 Fortesta. 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 this medicine

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

  • prostate cancer; or

  • male breast cancer.

To make sure Fortesta is safe for you, tell your doctor if you have:

  • a history of cancer;

  • enlarged prostate, urination problems;

  • sleep apnea (breathing stops during sleep);

  • heart disease;

  • a history of blood clots;

  • diabetes;

  • liver disease or kidney disease.

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.

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

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

Do not use Androderm on a boy younger than 15 years old. Do not use AndroGel on a boy younger than 18 years old. Testim should not be used on anyone younger than 18 years old.

How should I use Fortesta?

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

This medicine 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 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. Your pump is now ready to use.

  • 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 the gel evenly onto the front and inner part of each thigh.

  • Apply Fortesta gel in the morning. If you shower or bathe, the gel should be applied afterwards.

  • Apply the gel only to areas that will be covered by shorts or pants.

  • Let the application site dry completely before putting on shorts or pants.

  • Wash your hands right away with soap and water.

Avoid swimming, showering, or bathing for at least 2 hours after you apply the gel.

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

Cover treated skin areas with clothing to keep from 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.

While using Fortesta, you may need frequent blood tests.

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

Store 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.

What happens if I overdose?

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

What should I avoid while using Fortesta?

Do not apply this medicine to your penis or your scrotum.

Avoid swimming, bathing, or showering for 2 to 5 hours after applying Fortesta gel. Follow the directions provided with your specific brand.

Fortesta gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Fortesta side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Fortesta gel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Fortesta and call your doctor at once if you have:

  • increased urination (many times per day), loss of bladder control;

  • painful or difficult urination;

  • breast pain or swelling;

  • painful or bothersome erections;

  • swelling, rapid weight gain, shortness of breath during sleep;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

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.

Common Fortesta side effects may include:

  • headache, mood changes;

  • increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);

  • vomiting, diarrhea;

  • strange dreams;

  • frequent or prolonged erections; or

  • high blood pressure--severe headache, blurred vision, pounding in your neck or ears.

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 medicines you use, and those you start or stop using during your treatment with Fortesta, especially:

  • insulin;

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

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

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

Where can I get more information?

  • Your pharmacist can provide more information about Fortesta gel.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fortesta gel only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 13.01. Revision Date: 2014-09-02, 11:01:43 AM.

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