Testosterone is a buccal route medication system used to treat hypogonadal men whose sex glands produce little or no sex hormones. It is sold in the US under the brand name “Striant.”
Male sex hormones belong to a class known as “testosterone.” Impotence and decreased sexual desire are among the symptoms of hypogonadism. These hormones are responsible for the growth and development of male sex organs and secondary sex characteristics, such as facial hair.
Testosterone replacement therapy becomes necessary to regularize testosterone levels and functions in the body. The medicine is made up of anabolic–androgenic steroids, which are man-made variations of naturally-occurring testosterone.
Its use is restricted in women, children, older men, and men at risk of developing prostate cancer.
Testosterone is available in the US by doctor’s prescription only. Dosage is administered through the buccal cavity, using an extended release patch. It is applied, usually twice a day, and works by continuously releasing testosterone into the blood through the tissues in the mouth.
Testosterone therapy is recommended primarily when hypogonadism presents symptoms, such as impotence and “low” sex drive. The benefits of treatment include improved sex drive, mood, and energy levels. Muscle mass, bone density, and red blood cell production are also improved.
Extensive trials are still ongoing to assess the use and safety of testosterone in men. Because this medicine may cause many side effects, some of which may not yet be known, it is critical to have detailed pre-treatment discussions with your doctor. Thorough pre-screenings should be carried out as well.
Keep all appointments with your doctor and the laboratory before and during your treatment. Routine lab tests may be ordered to check your body's response to testosterone buccal systems.
As with many medications, testosterone (Striant) buccal system has a list of side effects, some of which can be severe.
These usually occur at the location where the medicine patch is placed and generally wears off within one to eight days.
Gum pain or blisters, change in taste, bad, unusual, or unpleasant (after) taste, swelling and pain in the breasts, and dizziness are side effects that are less common. Other less common side effects are:
These side effects may go away during treatment as your body adjusts to the medicine. If they do persist or worsen, or if there is any other unusual feelings or symptoms, tell your doctor right away.
While some side effects may not require medical attention, allow your doctor to determine this. Your doctor may also give you helpful advice on how to prevent or reduce some of the side effects.
Stop using testosterone buccal treatment and call your doctor immediately or seek emergency medical care if any of the following occurs:
Heart or blood vessel problems: Patients sometimes experience a heart attack or stroke during treatment. 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.
Blood clotting problems: Blood clots in the veins could cause life-threatening clots to occur in the lungs. Immediately report any pain, redness, or swelling in the arm or leg, shortness of breath, or trouble breathing.
Serious liver problems: 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 signs of serious liver problems.
Prostate symptoms: If you notice increased urination (especially at night), loss of bladder control, very little urine or a weak stream of urine, contact your doctor immediately.
Some patients may also experience a drop in the level of sperm production. This can sometimes cause fertility issues.
Also call your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.
Side effects may also be reported to the FDA at 1-800-FDA-1088.
The use of testosterone is prohibited in women, children, older men (geriatrics), men with enlarged prostate, and men at risk of developing prostate cancer. Studies do show positive evidence of fetal abnormalities in animals and pregnant women.
Older men are believed to be at a higher risk for experiencing heart problems or an enlarged prostate or developing prostate cancer.
Each testosterone (Striant buccal system) contains 30 mg of testosterone. It is white to off-white in color with a flat edge on one side and a convex surface on the other. It is supplied in transparent blister packs containing 10 doses. The medicine looks like a tablet, but it sticks to the gum like a patch.
Adults: Before administering the medicine, confirm the diagnosis of hypogonadism. Do this by measuring the serum testosterone concentrations on at least two separate days to confirm that the concentrations are below the normal range.
Carefully follow all directions on the prescription label or doctor’s advice. Use the recommended dosage which is usually one 30 mg Striant patch. Apply it to the gum region twice daily (mornings and evenings), every 12 hours. If your dose is different, do not change it unless your doctor tells you to do so.
To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured at four to 12 weeks after initiation of therapy to ensure proper serum testosterone concentrations are achieved.
Administer the patch as follows:
Children, women, and geriatrics: Use not recommended
If you miss a dose, remove the old tablet and place a new one in your mouth as soon as you remember.
If the patch falls out of position within the first eight hours of dosing, replace with a new one and continue for a total of 12 hours, counting from the placement of the first system.
If the system falls out of position after eight hours of dosing, a new buccal system should be applied. Leave it in place for 12 hours then continue with the next regularly scheduled dosing.
Do not use extra medicine to make up the missed dose.
If unsure, call your doctor or pharmacist for additional instructions.
Seek emergency care right away if you experience blurred vision, headache, seizures, slurred speech, sudden and severe inability to speak, temporary blindness, or weakness in the arm or leg on one side of the body that is sudden and severe.
Call the Poison Help line at 1-800-222-1222 if you or anyone accidentally swallows the medication.
Certain medicines should not be used together at all, as they may interact adversely. Tell your doctor if you are using the following medicines. Their use together with testosterone is not usually recommended, but may be required in some cases.
Using testosterone with any of the listed medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Drugs other than those listed here, including insulin used by diabetic patients, may also interact with testosterone.
The medicine should also not be used with licorice, but if required your doctor may determine use and dosage.
The medicine may interact adversely with diseases or medical conditions such as enlarged prostate, prostate cancer, liver or kidney disease, sleep apnea, heart disease, diabetes, breast cancer, blood disorder, and stroke.
Discuss with your doctor or healthcare professional the use of your medicine with food, alcohol, or tobacco to be aware of any possible interactions.
In addition to the precautions before using testosterone, follow all directions given by your doctor and prescription label. Pay close attention to the following warnings before and during treatment:
Store at 20-25°C (68-77°F). Protect from heat and moisture. Protect from freezing.
Do not store in the bathroom.
Store in a safe place where no one else can access and use it accidentally or on purpose. Always check to see if the correct number of systems remain and that none is missing.
Damaged blister packages should not be used.
Do not give the medication to anyone else, even if you have the same symptoms.
Keep out of the reach of children. To protect young children from poisoning, always lock safety caps and immediately place the medication out of their sight and reach.
Do not keep outdated medicine or medicine that is no longer needed. Safely discard used medicine in household trash in a manner that prevents accidental ingestion by other adults, children or pets.
Do not flush it down the toilet.
Check with your healthcare professional prior to disposal for additional information on safe disposal.
Consider using the medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community.
The use of testosterone (Striant) buccal therapy to treat the condition hypogonadism in men is established and proven effective. Nevertheless, due to a risk of some serious side effects, male hypogonadism must be properly diagnosed.
The patient’s health must also be carefully and thoroughly assessed to determine whether this medication should be used.
Despite the individualized positive results that have been seen, the non-exhaustive list of side effects, both mild and severe, may be a daunting factor for many patients. The risk of adverse reaction is always imminent. This is because side effects and results vary from patient to patient and may only be accurately determined once treatment begins.
The potential for testosterone to adversely interact with other medicines, diseases, medical conditions, and food cannot be overlooked. The medication can affect a female sexual partner, such as one who is pregnant, possibly resulting in birth defects. This further indicates the far-reaching effects of testosterone.
It, therefore, becomes critical for patients considering testosterone buccal system therapy to determine whether the benefits outweigh the risks. Intensive discussion with a doctor or medical professional is highly recommended before beginning the treatment.
With the help of their doctor, patients can make an informed decision. Pre-therapy lab testing of the patient’s body and health may help the decision-making process.
Even though the safety of use and effectiveness of the medicine are established for treating male hypogonadism, experts have cautioned that the full gamut of benefits and risks of long-term testosterone therapy are yet to be determined.