Testosterone (Buccal route)
- Patch, Extended Release
Uses of This Medicine:
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 male sex organs and maintenance of secondary sex characteristics.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, testosterone is used in certain patients with the following medical conditions:
- Female-to-male transsexualism in patients with gender identity disorder, (person who is born as a woman but adapts to a man's lifestyle, sees herself as a man, and feels like a man instead of a woman).
Before Using This Medicine:
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:
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.
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.
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.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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.
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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.
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:
- 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
- Hypercalcemia (high calcium in the blood) or
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Liver problems or
- Sleep apnea (breathing problem)—Use with caution. May make these conditions worse.
- Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases.
- Heart disease or
- Kidney disease or
- Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.
Proper Use of This Medicine:
This medicine 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.
This medicine 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 this medicine 2 times a day, once in the morning and once in the evening (about 12 hours apart), unless your doctor tells you differently.
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.
- For hormone replacement:
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.
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.
Precautions While Using This Medicine:
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 this medicine. Blood and urine tests will be needed to check for unwanted effects.
This medicine 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 this medicine, tell your doctor right away.
This medicine 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.
This medicine 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.
In some cases, this medicine may decrease the amount of sperm men make and affect their ability to have children. Talk with your doctor before you use this medicine 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.
This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.
This medicine 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.
Side Effects of This Medicine:
- Incidence not known
- Pain, redness, or swelling in the arm or leg
- trouble breathing
- Symptoms of overdose
- Blurred vision
- slurred speech
- sudden and severe inability to speak
- temporary blindness
- weakness in the arm or leg on one side of the body, sudden and severe
- More common
- Gum or mouth irritation
- Less common
- Bad, unusual, or unpleasant (after) taste
- bleeding gums
- blemishes on the skin
- breast pain
- change in taste
- dry mouth
- enlarged breasts
- fear or nervousness
- feeling sad or empty
- gum pain or blisters
- itching skin
- loss of appetite
- loss of interest or pleasure
- lower back or side pain
- mouth ulcers
- noisy breathing
- painful or difficult urination
- passing of gas
- pounding in the ears
- quick to react or overreact emotionally
- rapidly changing moods
- redness and swelling of the gums
- slow or fast heartbeat
- stinging of the lips
- stomach cramps, pain, fullness, or discomfort
- swelling of the gums
- swelling of the nose
- trouble concentrating
- trouble sleeping
- unusual tiredness or weakness
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014