Testosterone Buccal

Testosterone buccal systems are used to treat symptoms of low testosterone in adult men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland, (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain lab tests to check your testosterone levels to see if they are low before you begin to use testosterone buccal. Testosterone should not be used treat the symptoms of low testosterone in men who have low testosterone due to aging ('age-related hypogonadism'). Testosterone is in a class of medications called androgenic hormones. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone buccal systems work by replacing testosterone that is normally produced by the body.

Before using testosterone buccal systems,

• tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in testosterone buccal system. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), insulin (Apridra, Humalog, Humulin, others), oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor will probably tell you that you should not use testosterone buccal system.
• tell your doctor if you have or have ever had benign prostate hyperplasia (BPH; an enlarged prostate), sleep apnea (a sleep disorder that causes breathing to stop for short periods during sleep), high levels of calcium in your blood, diabetes, or heart, kidney, liver, or lung disease.
• you should know that testosterone buccal systems are only for use in adult men. Children, teenagers, and women should not use this medication. Testosterone may stop bone growth and cause precocious puberty (early puberty) in children and teenagers. Testosterone may cause deepening of voice, hair growth in unusual places, genital enlargement, decrease in breast size, male-pattern hair loss, and unusual menstrual cycles in women. If testosterone is used by women who are pregnant, may become pregnant, or are breast-feeding, it may harm the baby.
• you should check your gums regularly while you are using this medication. Call your doctor if you notice any changes in your gums.
• you should know that there have been reports of serious side effects in people who use testosterone at higher doses, along with other male sex hormone products, or in ways other than directed by a doctor. These side effects may include a heart attack, heart failure, or other heart problems; stroke and mini-stroke; liver disease; seizures; or mental health changes such as depression, mania (frenzied, abnormally excited mood), aggressive or unfriendly behavior, hallucinations (seeing things or hearing voices that do not exist), or delusions (having strange thoughts or beliefs that have no basis in reality). People who use higher doses of testosterone than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, craving, irritability, restlessness, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop using testosterone buccal. Be sure to use testosterone buccal system exactly as directed by your doctor.

Testosterone buccal systems may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• irritation, redness, pain, tenderness, swelling, toughening, or blistering of gums
• stinging or swelling of lips
• unpleasant or bitter taste in mouth
• difficulty tasting food
• headache
• acne
• breast pain or enlargement

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• lower leg pain, swelling, warmth, or redness
• shortness of breath
• chest pain
• difficulty breathing, especially at night
• swelling of the hands, feet, and ankles
• sudden unexplained weight gain
• slow or difficult speech
• dizziness or faintness
• weakness or numbness of an arm or leg
• erections of the penis that happen too often or do not go away
• difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
• vomiting
• nausea
• extreme tiredness
• yellowing of the skin or eyes
• dark urine

Testosterone buccal systems may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children.

Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of using this medication.

Testosterone buccal systems may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store testosterone buccal systems in a safe place so that no one else can use it accidentally or on purpose. Keep track of how many systems are left so you will know if any are missing.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Your doctor will test the testosterone levels in your blood before you start and while you are using testosterone.

testosterone comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Make sure that you wash your hands with soap and water before and after applying the medicine.

testosterone looks like a tablet, but it sticks to your gum like a patch. To use the patch:

• Keep the patch in the blister pack until you are ready to use it. Do not use damaged blister packs.
• Put the flat side of the patch on your fingertip. Place the patch against your gum and to the left or right of your front teeth. Gently push the it up as high as it will go. Then push on the patch from the outside of your mouth for at least 30 seconds. The patch should stick to your gum.
• Do not chew or swallow the patch.
• Each time you put in a new patch, put it on the side opposite from where you put the last one.
• Keep the patch in your mouth all the time, unless you are changing patches. Check to make sure the patch is still in place after you eat or drink, use mouthwash, or brush your teeth.
• To remove a patch, use your finger to gently loosen it. Then slide it down over your teeth and take it out.
• Use testosterone 2 times a day, once in the morning and once in the evening (about 12 hours apart), unless your doctor tells you differently.

Dosing

The dose of testosterone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of testosterone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For buccal dosage form (tablets):
  • For hormone replacement:
    • Adults—30 milligrams (mg) applied on the upper gums two times a day (about 12 hours apart).
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

If the patch does not stick or falls off within the first 8 hours, take it out and put in a new one. Put in the next patch at the regularly scheduled time. If the patch falls off after more than 8 hours, take it out and put in a new one. This will count as your next dose, and the patch can stay in place for 12 hours.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the medicine in a safe place. Do not give it to anyone else, even if you have the same symptoms.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check for any problems or unwanted effects that may be caused by testosterone. Blood and urine tests will be needed to check for unwanted effects.

testosterone should not be used by women who are pregnant or might become pregnant. Testosterone may cause birth defects if a pregnant woman comes in contact with the medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using testosterone, tell your doctor right away.

testosterone may increase the risk of prostate cancer, especially in older men. Make sure your doctor knows if you have prostate cancer, or if anyone in your family has prostate cancer.

testosterone may cause blood clotting problems. Tell your doctor right away if you have pain, redness, or swelling in the arm or leg, shortness of breath, or trouble breathing.

testosterone may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.

testosterone may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

In some cases, testosterone may decrease the amount of sperm men make and affect their ability to have children. Talk with your doctor before you use testosterone if you plan to have children.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

testosterone may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

testosterone may cause changes in the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to adjust the cholesterol and fats. Talk to your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

You should not use this medicine 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.

This medicine should not be used by a woman or a child.

You should not use this medicine 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 testosterone buccal 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.

This medicine 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.

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

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