Testosterone

Testosterone is a sex hormone medication taken orally. It works by replacing deficient sex hormones in men diagnosed with hypogonadism.

Overview

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.

Conditions treated:

  • Hypogonadism

Type of medicine:

  • Androgen

Benefits

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.

Before using testosterone

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.

Be sure to tell your doctor about the following:

  • Prescription and over-the-counter (OTC) medicines, herbal treatments or vitamin supplements you take
  • Any allergies to foods, dyes, preservatives, or animals
  • Present medical problems or conditions (or family history of) or drug abuse (or history of) so your doctor can better determine if testosterone is right for you
  • Use of insulin or any kind of steroid medications (Testosterone may adversely interact with insulin and steroids such as corticotropin and cortisone.)
  • Plans to have children (The medicine may affect your ability to have children.)
  • Pregnancy of any sexual partner, so you can discuss any possible issues relating to your use of testosterone

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.

Side Effects:

As with many medications, testosterone (Striant) buccal system has a list of side effects, some of which can be severe.

Common side effects

  • Irritation of the gum or mouth

These usually occur at the location where the medicine patch is placed and generally wears off within one to eight days.

Less common side effects

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:

  • Bleeding gums
  • Blemishes on the skin
  • Cough
  • Crying
  • Depersonalization
  • Diarrhea
  • Discouragement
  • Dry mouth
  • Dysphoria
  • Enlarged breasts
  • Euphoria
  • Fear or nervousness
  • Feeling sad or empty
  • Hoarseness
  • Indigestion
  • Irritability
  • Itching skin
  • Loss of appetite
  • Loss of interest or pleasure
  • Lower back or side pain
  • Mouth ulcers
  • Nausea
  • Noisy breathing
  • Painful or difficult urination
  • Paranoia
  • 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
  • Tiredness
  • Toothache
  • Trouble concentrating
  • Trouble sleeping
  • Unusual tiredness or weakness
  • Vomiting

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.

Serious side effects

Stop using testosterone buccal treatment and call your doctor immediately or seek emergency medical care if any of the following occurs:

  • An allergic reaction (difficulty breathing; closing of the throat; swelling of the face, lips, or tongue; or hives)
  • Nausea or vomiting
  • Changes in skin color
  • Swelling of the ankles or legs
  • Breathing disturbances, including those associated with sleep
  • Too frequent or prolonged erections
  • Liver damage (yellowing of the skin or eyes)

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.

Limitations on use

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.

Dosage:

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:

  • Keep the patch in the blister pack until you are ready to use it.
  • 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 patch 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.
  • Each time you put in a new patch, put it on the side opposite from where you put the last one. This will help reduce irritation of the gum.
  • 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.

Children, women, and geriatrics: Use not recommended

Missed dose

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.

Overdose

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.

Interactions:

With other drugs

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.

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

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.

With medical conditions

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.

Interactions with food/tobacco/alcohol

Discuss with your doctor or healthcare professional the use of your medicine with food, alcohol, or tobacco to be aware of any possible interactions.

Warnings:

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:

  • Use the medication by mouth only. Do not chew or swallow.
  • Do not use damaged blister packs.
  • Do not take with other medicines unless directed by your doctor. These include prescription or OTC medicines, herbal treatments, and vitamin supplements.
  • The undissolved medication must be removed from your mouth after 12 hours. Immediately insert a new patch to begin the next dosage.
  • Ensure the patch stays in place by frequently checking, especially after eating or drinking.
  • Remove before routine morning and evening oral care is performed. Follow by applying a new buccal system.
  • Discontinue testosterone treatment if serum testosterone concentrations are consistently outside of the normal range (300 to 1050 ng/dL) despite the use of one buccal system applied twice daily.
  • This medicine should not be used by women, children or older men.
  • You should not use testosterone if you have enlarged prostate or are at risk for prostate cancer.
  • Do not use if you have prostate cancer or male breast cancer.

Storage

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.

Summary:

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.

https://www.harvardprostateknowledge.org/a-harvard-expert-shares-his-thoughts-on-testosterone-replacement-therapy

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Last Reviewed:
December 24, 2017
Last Updated:
December 22, 2017
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