Striant is used to treat men with low testosterone levels.

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

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

You should not use Striant if you have prostate cancer or male breast cancer.

Misuse of testosterone can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.

Striant should not be used by a woman or a child.

Notify your doctor if you experience nausea; vomiting; swelling of the ankles; changes in skin color; too frequent or prolonged erections; breathing disturbances, including those associated with sleep; yellowing of the skin or eyes; dark colored urine; or problems with urination.

Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Regularly inspect the gum area where the Striant buccal system is applied. Promptly report any changes to your doctor or dentist.

Use Striant exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

To use Striant buccal system:

• Hold one buccal system with the flat side on your fingertip. Place the curved side onto your gum, as high as possible above the left or right incisor tooth. Hold your finger on the outside of your lip over the system for 30 seconds to ensure the system is attached to the gum. If the system sticks to the cheek and not the gum, this is acceptable.

• The Striant buccal system should remain in place for 12 hours. To remove the system, move it slightly toward the back or front of the mouth then slide it toward the teeth from removal. With each new application, rotate to alternate sides of the mouth. This avoids scratching the gum. Check to see that the system is in place after eating, drinking, brushing the teeth, or using mouthwash.

• As the Striant buccal system absorbs moisture from the mouth, it will begin to soften and will mold to the shape of the gum. The system does not dissolve completely, but will remain in place. It will not move until you remove it.

• If a buccal system falls off before 8 hours of use, remove it and replace it with a new system in the same place.

• Change the buccal system and alternate sides of the mouth 12 hours after application of the original system. If a buccal system falls off after 8 hours but before 12 hours of use, remove the system and replace it with a new system above the opposite incisor. This will serve as the second dose for the day.

• Do not chew or swallow Striant.

• Regularly inspect the gum where the Striant buccal system is applied. Promptly report any changes to your doctor or dentist.

Your doctor may want to perform tests to monitor the amount of testosterone in the body, liver function, prostate function, cholesterol levels, or other factors during treatment with Striant.

It is important to use Striant regularly to get the most benefit.

Dispose of all used Striant buccal systems properly, out of the reach of children and pets.

Store Striant at room temperature away from moisture and heat. Keep the tablet in its blister pack until you are ready to take it. Use dry hands to remove the tablet and place it in your mouth.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

You should not use Striant if you have ever had an allergic reaction to a testosterone product, or if you have:

• prostate cancer; or

• male breast cancer.

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

• heart disease, history of heart attack or stroke;

• a history of blood clots;

• sleep apnea (breathing stops during sleep), or risk factors such as chronic lung disease, or being overweight;

• liver or kidney disease;

• urination problems, enlarged prostate; or

• if you use a blood thinner such as warfarin, and you have routine "INR" or prothrombin time tests.

Striant should not be used by a woman. Testosterone could cause birth defects in an unborn baby if the mother uses this medicine during pregnancy. Testosterone can also cause serious side effects in a nursing baby if the mother uses the medicine while breast-feeding.

Striant is not approved for use by anyone younger than 18 years old.

Remove the old tablet and place a new one in your mouth as soon as you remember. Do not use extra medicine to make up the missed dose.

An overdose of Striant is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Striant: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe gum or mouth irritation;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• breathing problems during sleep;

• chest pain or pressure, pain spreading to your jaw or shoulder;

• prostate symptoms - increased urination (especially at night), loss of bladder control, very little urine or a weak stream of urine;

• 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.

Common Striant side effects may include:

• pain, swelling, or tenderness of your gums;

• headache;

• more frequent or prolonged erections;

• altered sense of taste; or

• bitter or unpleasant taste in the mouth.

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.

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

• insulin;

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

• steroid medicine (dexamethasone, 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.