In the U.S.—

• Androgen

Testosterone ( tes-TOS-te-rone) are male hormones. Some are naturally produced in the body and are responsible for the growth and development of male sex organs

This medicine is available only with your doctor's prescription, in the following dosage forms:

Buccal
• Buccal system (Tablet-like gum patch) (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For testosterone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to testosterone. Also tell your doctor and pharmacist if you are allergic to any other substances, such as [foods, preservatives, or dyes].

Pregnancy—Testosterone should not be used by women during pregnancy. It has been shown to cause serious birth defects and other problems in animals. Be sure you have discussed this with your doctor.

Breast-feeding—Use is not recommended in nursing mothers since androgens may pass into the breast milk and may cause unwanted effects in the nursing baby.

Children—Studies on this medicine have been done only on adult patients, and there is no specific information comparing use of testosterone in children with use in other age groups

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However older men may be at increased risk for development of prostatic hyperplasia and prostatic cancer.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking testosterone, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Insulin (e.g., Humulin, Lente, Novolin )—May lower blood sugar

• Breast cancer (in males) or
• Prostate cancer—Androgens can cause growth of these tumors.

• Diabetes mellitus (sugar diabetes)—Testosterone may decrease blood sugar levels. Careful monitoring of blood glucose should be done.

• Heart disease or
• Kidney disease or
• Liver disease—These conditions can be worsened by the fluid retention (keeping too much water in the body) that can be caused by androgens. Also, liver disease can prevent the body from removing the medicine from the bloodstream as fast as it normally would. This could increase the chance of side effects occurring.

• Sleep apnea—This condition may become worse, especially in patients with risk factors such as obesity or chronic lung disease.

Importance of reading the patient directions carefully before using the buccal system

Proper administration technique

Proper dosing. Use this medicine only as directed.

Proper storage

Dosing—

• For buccal dosage form:
  • For testosterone hormone replacement in men
    • Adults—30 milligrams (mg) applied to your upper gum above the left or right incisor twice a day

Missed dose—

If the buccal system fails to properly adhere to the gum or should fall off during the 12–hour dosing interval, the old one should be removed and a new buccal system applied. If the old one falls out within 4 hours before the next dose, a new system should be applied and it may remain in place until the time of the next regularly scheduled dosing; not doubling doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children and pets.

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits to check your progress during therapy.

For patients with diabetes mellitus (sugar diabetes), this medicine may lower blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Tell your doctor if you have too frequent or persistent erections of the penis.

Tell your doctor if you have any nausea, vomiting, changes in skin color or swelling of the ankles.

Tell your doctor if you experience any breathing problems, including those while you sleep.

Regularly check your gums where the buccal system is applied to check for any abnormalities and report findings to your doctor.

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Blurred vision;  headache;  sudden and severe inability to speak;  seizures;  slurred speech;  temporary blindness;  weakness in arm and/or leg on one side of the body, sudden and severe 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Gum or mouth irritation 
  
  

• Less common
  • Abnormal liver function test;  abnormal renal function;  bad unusual or unpleasant (after) taste;  bleeding gums;  blemishes on the skin, pimples;  blurred vision;  breast enlargement;  breast pain;  buccal inflammation;  change in taste ;  cough;  crying;  depersonalization;  diarrhea;  difficulty breathing;  discouragement ;  dry mouth;  dizziness;  dysphoria;  euphoria;  fear;  feeling sad or empty;  fever or chills;  gum blister;  gum pain;  headache;  hoarseness ;  indigestion;  irritability; ;  itching skin;  loss of appetite;  loss of interest or pleasure;  lower back or side pain;  mental depression ;  mouth ulcers;  nausea;  nervousness;  noisy breathing;  paranoia;  painful or difficult urination ;  passing of gas;  pounding in the ears;  quick to react or overreact emotionally ;  rapidly changing moods;  redness and swelling of gums;  shortness of breath ;  slow or fast heartbeat;  stomach cramps;  stomach pain, fullness or discomfort ;  stinging of lips;  swelling of gums;  swelling or inflammation of the mouth;  swelling of the nose;  taste bitter;  tightness in chest;  tiredness;  toothache;  trouble concentrating;  trouble sleeping;  unusual tiredness or weakness;  vomiting;  wheezing 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.