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Testosterone is a prescription medication used to treat low testosterone levels (hypogonadism) in men who do not produce enough natural testosterone. It may also be used to treat delayed puberty in adolescent males. Testosterone may also be administered to women to treat certain types of cancer.

Testosterone is a hormone that is usually produced by the body. It controls the growth, development, and function of male sexual organs and characteristics.

This medication comes in several topical forms for the skin, nose, and mouth that are applied to the body one to three times daily, depending on the dosage form.

This medication is also available in an injectable form to be given directly into a muscle (IM) by a healthcare professional.

Common side effects of testosterone include irritation and redness at the site of application, headache, acne, stomach pain, nervousness, hair loss, changes in mood and behavior, and changes in the ability to taste or smell.

Topical:

Testosterone is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone.

Injectable:

Testosterone is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone. Injectable forms of testosterone may also be used to treat delayed puberty in adolescent males. Testosterone may also be administered to women to treat certain types of cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Actient Pharmaceuticals, LLC.

• Columbia Laboratories, Inc.

Serious side effects have been reported with testosterone. See the “Testosterone Precautions” section.

Topical:

Common side effects of topical testosterone include the following:

• Breast enlargement
• Decreased sexual desire
• Acne
• Hair loss
• Hot flashes
• Depression
• Changes in mood
• Nervousness
• Headache
• Weakness
• Insomnia
• Dry skin
• Changes in the ability to taste or smell
• Skin irritation at the site of application

Injectable:

Common side effects of injectable testosterone include the following:

• Nausea and vomiting
• Changes in skin color
• Ankle swelling
• Increased calcium levels in the blood
• Enlarged breasts
• Enlarged prostate in men
• Deepening of the voice, the appearance of facial hair, and acne in women

This is not a complete list of testosterone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Oral steroids such as dexamethasone (Decadron, Dexone), methylprednisone (Medrol), and prednisone (Deltasone)
• Inhaled steroids such as beclomethasone (QVAR), budesonide (Pulmicort, Rhinocort), flunisolide (AeroBid), fluticasone (Flovent, in Advair), and triamcinolone (Azmacort)
• Topical steroids such as alclometasone (Aclovate), betamethasone (Diprolene, Valisone), clobetasol (Temovate), desonide (DesOwen), Desoximetasone (Topicort), diflorasone (Psorcan, Florone), Fluocinolone (Derma-Smoother, Flurosyn, Synalar), fluocinonide (Lidex), flurandrenolide (Cordran), fluticasone (Cutivate), halcinonide (Halog), halobetasol (Ultravate), hydrocortisone (Cortizone, Westcort), mometasone (Elocon), and triamcinolone (Aristocort)
• Anticoagulants such as warfarin (Coumadin)
• Cosyntropin
• Propanolol (Inderal)
• Insulin

This is not a complete list of testosterone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with topical testosterone including the following:

• Swelling of the hands, feet, ankles, and lower legs
• Breathing problems, especially during sleep
• Excessive frequency or duration of penile erections in males
• Difficulty urinating or changes in urination habits
• Changes in skin color
• Liver dysfunction or liver cancer

Serious side effects have been reported with injectable testosterone including the following:

• Virilization in women, which includes amenorrhea or menstrual irregularities, deepening of the voice, clitoral enlargement
• Sexual changes or dysfunction in males, which includes breast enlargement and excessive frequency or duration of penile erections

Do not take testosterone if you:

• are allergic to testosterone or to any of its ingredients
• are a male with breast or prostate cancer
• are a woman who is or may become pregnant

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of testosterone, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking testosterone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to testosterone or to any of its ingredients
• have or have had prostate cancer or an enlarged prostate
• have or have had breast cancer
• have sleep apnea
• have heart problems
• have diabetes
• have kidney disease
• have lung disease
• have liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Testosterone falls into category X. It has been shown that women taking testosterone during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. Testosterone should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if testosterone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using testosterone.

Take testosterone exactly as prescribed.

Topical:

Testosterone comes in topical forms, including gels and transdermal patches to be applied to the skin, buccal systems to be applied to the upper gum, and gels to be applied into the nose. Testosterone is usually applied one to three times daily, depending on the specific formation.

Injectable:

This medication is available in an injectable form to be given directly into a muscle (IM) by a healthcare professional.

If you miss a dose, apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of testosterone at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age
• your gender

Topical:

The recommended dose of testosterone gel for the treatment of hypogonadism in males is 50 to 100 mg daily applied to the skin. The recommended dose of the nasal formulation of testosterone is 11 mg daily. The recommended dose of the buccal system of testosterone is 30 mg twice daily. The recommended dose of the testosterone transdermal patch is 4 to 6 mg daily.

Injectable:

The recommended dose of testosterone for the treatment of hypogonadism in males is 50 to 400 mg every 2 to 4 weeks.

The recommended dose of testosterone for the treatment of delayed puberty in adolescent males is 50 to 200 mg every 2 to 4 weeks for 4 to 6 months.

If you take too much testosterone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If testosterone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store testosterone at room temperature.

Keep this and all medicines out of the reach of children.

Used pumps, packets, or storage containers for this medication should be disposed of in household trash in a manner that prevents accidental application or ingestion by children or pets.

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

• Virilization has been reported in children who were secondarily exposed to testosterone gel.
• Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
• Healthcare providers should advise patients to strictly adhere to recommended instructions for use.