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Detailed instructions on how to use testosterone

Descriptions

Testosterone is used for the treatment of men whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics. This medicine is not for use in women.

This medicine is available only with your doctor’s prescription.

Possible risks

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

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.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using 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.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

  • Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases (blood clots).
  • 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, or history of or
  • Heart or blood vessel disease or
  • Hypercalcemia (high calcium in the blood) or
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Hypertension (high blood pressure) or
  • Liver disease or
  • Sleep apnea (breathing problem) or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Breast cancer (in males) or
  • Hypogonadism, age-related or
  • Prostate cancer, known or suspected—Should not be used in patients with these conditions.
  • 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.
  • Lung disease, chronic or
  • Obesity—Use with caution. May increase risk for more side effects.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food.

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 low testosterone levels:

Adults

Dose is based on the testosterone concentration level in your blood and must be determined by your doctor. At fisrst, the dose is 237 milligrams (mg) taken 2 times a day, in the morning and in the evening. Your doctor may adjust your dose as needed. However, the dose is not more than 396 mg per day.

Children

Use and dose must be determined by your doctor.

For oral dosage form

Adults

Dose is based on the testosterone concentration level in your blood and must be determined by your doctor. The usual dose is 225 milligrams (mg) 2 times a day, in the morning and in the evening.

Children

Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

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