Testosterone

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Testosterone


Generic Name: Testosterone Buccal System (tes-TOS-ter-ohn)
Brand Name: Striant

Testosterone is used for:

Treating symptoms of low testosterone in adult men when their bodies do not make any testosterone or not enough testosterone (hypogonadism). It may be used for certain conditions as determined by your doctor.

Testosterone is a male sex hormone. It works by replacing or supplementing the testosterone that is naturally made in the body.

Do NOT use Testosterone if:

  • you are allergic to any ingredient in Testosterone
  • you are female
  • you are pregnant or breast-feeding
  • you have breast cancer or known or suspected prostate cancer

Contact your doctor or health care provider right away if any of these apply to you.

Before using Testosterone :

Some medical conditions may interact with Testosterone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you plan to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart disease, heart failure, coronary artery disease, angina (chest pain), high cholesterol levels, swelling (edema), lung disease, or sleep apnea (long pauses in breathing while you sleep)
  • if you have diabetes, an enlarged prostate, kidney or liver disease, high blood calcium levels, or obesity

Some MEDICINES MAY INTERACT with Testosterone . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbamazepine or macrolide immunosuppressants (eg, tacrolimus) because actions and side effects may be increased by Testosterone
  • Oral anticoagulants (eg, warfarin) because side effects, including risk of bleeding, may be increased by Testosterone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Testosterone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Testosterone :

Use Testosterone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Testosterone comes with an additional patient leaflet. Read it carefully and reread it each time you get Testosterone refilled.
  • Do not remove the medicine from the blister until you are ready to take Testosterone . Make sure that your hands are dry when you open Testosterone . Use the medicine immediately after opening the blister pack. Do not store the removed tablet for future use.
  • Use Testosterone twice a day, once in the morning and once in the evening (about 12 hours apart) unless otherwise instructed by your health care provider. You may find it convenient to apply the morning dose after brushing your teeth following breakfast and the evening dose following your evening meal.
  • Do not chew or swallow the system.
  • Tear off an individual unit and peel off the paper backing. Push the system through foil from the front.
  • Place the flat side of the system on your fingertip. Gently push the curved side of the system just above the incisor tooth (on either side of the mouth). Each time you apply a new system, apply it to the opposite side of your mouth.
  • Hold the system firmly in place with a finger on the outside of your upper lip for 30 seconds to make sure it sticks. The system is designed to stay in place until it is removed.
  • If the system sticks to your cheek and not your gum, there is no need to replace the system.
  • Do not remove the system until it is time for the next dose.
  • To remove the system, gently slide it downward from the gum towards the tooth to avoid scratching the gum.
  • Check to see if the system is in place after brushing your teeth, using mouthwash, eating food, or drinking beverages. If the system does not stick or falls off, follow the directions below.
  • If the system does not stick or falls off within the first 8 hours, remove the original system and apply a new one. Apply the next system about 12 hours after the original system that you applied first.
  • If the system falls off after 8 hours but before 12 hours, replace the original system. This replacement will serve as the second dose for the day.
  • After removing the used medicine, discard the system out of reach of children and pets.
  • If you miss a dose of Testosterone , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Testosterone .

Important safety information:

  • Regularly inspect your gums where you apply the system. Gum side effects (redness, irritation, swelling, or pain) are usually temporary. Most only last for a few days, but some may last up to 2 weeks. Contact your health care provider at once if you have any unusual side effects.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Testosterone .
  • Additional monitoring of your dose or condition may be needed if you are taking corticosteroids (eg, prednisone), insulin, oral diabetic medicines (eg, glyburide, metformin), or oxyphenbutazone.
  • Diabetes patients - Testosterone may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • Testosterone can affect the results of certain LAB TESTS. Make sure lab technicians and your doctors know you use Testosterone .
  • LAB TESTS, including liver function, blood counts, blood cholesterol, prostatic specific antigen, and blood testosterone, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Testosterone may increase the risk of an enlarged prostate or prostate cancer in ELDERLY patients.
  • Testosterone is not recommended for use in CHILDREN or adolescents younger than 18 years of age; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Testosterone is not for use in women, especially women who are pregnant, planning to become pregnant, or breast-feeding. Testosterone has been shown to cause harm to the fetus. Testosterone may have serious, harmful effects on a breast-feeding infant. Do not breast-feed while using Testosterone .

When used for long periods of time, some people develop a need to continue taking Testosterone . This is known as DEPENDENCE or "addiction." Testosterone has a potential for abuse that may lead to moderate or low physical DEPENDENCE or high psychological DEPENDENCE.

Possible side effects of Testosterone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; bitter or strange taste in mouth; change in sex drive; fatigue; gum or mouth irritation; gum pain; gum tenderness or swelling; hair loss; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast growth or pain; change in the size or shape of the testicles; dark urine or light-colored bowel movements; depression or mood changes; dizziness; gingivitis; interrupted breathing while sleeping; loss of appetite; nausea; painful or prolonged erection; stomach pain; swelling of the ankles or legs; urination problems; weight gain; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; one-sided weakness; vision problems.

Proper storage of Testosterone :

Store Testosterone at room temperature between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Do not use a damaged blister package. Throw Testosterone away in a household trash can in a way that prevents children or pets from accidentally using or taking them.

Keep Testosterone out of the reach of children and away from pets.

General information:

  • If you have any questions about Testosterone , please talk with your doctor, pharmacist, or other health care provider.
  • Testosterone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Testosterone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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