Testosterone (Buccal Route)

Name: Testosterone (Buccal Route)

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of testosterone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of testosterone have not been performed in the geriatric population. However, elderly patients are more likely to have heart or prostate problems (including enlarged prostate), which may require caution in patients receiving this medicine.

Drug Interactions

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Anisindione
  • Bupropion
  • Dasabuvir
  • Dicumarol
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Phenprocoumon
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Licorice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Breast cancer (males) or
  • Prostate cancer, known or suspected—Should not be used in patients with these conditions.
  • Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
  • Diabetes or
  • Drug abuse or dependence, or history of or
  • Enlarged prostate or
  • Heart attack, history of or
  • Hypercalcemia (high calcium in the blood) or
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Liver problems or
  • Sleep apnea (breathing problem) or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases.
  • Heart disease (eg, congestive heart failure) or
  • Kidney disease or
  • Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.

Dosing

The dose of this medicine 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 this medicine. 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.
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