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testosterone buccal system


Generic Name: testosterone buccal (tes TOS ter one BUK al)
Brand Name: Striant

What is testosterone buccal?

Testosterone is a naturally occurring male sex hormone necessary for many processes in the body.

Testosterone buccal is used to treat men with low testosterone levels.

Testosterone buccal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about testosterone buccal?

You should not use this medicine if you have prostate cancer or male breast cancer.

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This medicine should not be used by a woman or a child.

What should I discuss with my healthcare provider before using testosterone buccal?

You should not use this medicine if you have ever had an allergic reaction to a testosterone product, or if you have:

  • prostate cancer; or

  • male breast cancer.

To make sure testosterone buccal is safe for you, tell your doctor if you have:

  • heart disease, history of heart attack or stroke;

  • a history of blood clots;

  • sleep apnea (breathing stops during sleep), or risk factors such as chronic lung disease, or being overweight;

  • liver or kidney disease;

  • urination problems, enlarged prostate; or

  • if you use a blood thinner such as warfarin, and you have routine "INR" or prothrombin time tests.

This medicine should not be used by a woman. Testosterone could cause birth defects in an unborn baby if the mother uses this medicine during pregnancy. Testosterone can also cause serious side effects in a nursing baby if the mother uses the medicine while breast-feeding.

How should I use testosterone buccal?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You will use this medicine once in the morning and once in the evening (every 12 hours). The buccal tablet is placed above your upper teeth near the center of your mouth.

Carefully follow the application instructions that come with testosterone buccal. Ask your doctor or pharmacist if you have any questions.

One side of the buccal tablet is flat and one side is curved. The curved side fits against your gum, with the flat side facing out.

Use only 1 tablet at a time.

Do not chew or swallow a testosterone buccal tablet. It should stay in place on your gum all 12 hours of wearing time.

Use a different side of your mouth each time you use this medicine. Do not place a tablet on the same side two times in a row.

Check to make sure the tablet is still in place after eating, drinking, or brushing your teeth. If a tablet gets loose or falls out, throw it away and put in a new tablet. Keep this tablet in place for the rest of the 12-hour wearing time. Do not change your dosing schedule.

At the end of the 12-hour wearing time, remove the tablet gently to avoid scraping your gum.

While using testosterone buccal, you may need frequent blood tests.

Use testosterone buccal regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep the tablet in its blister pack until you are ready to take it. Use dry hands to remove the tablet and place it in your mouth.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Remove the old tablet and place a new one in your mouth as soon as you remember. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of testosterone buccal is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

What should I avoid while using testosterone buccal?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Testosterone buccal side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe gum or mouth irritation;

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • breathing problems during sleep;

  • chest pain or pressure, pain spreading to your jaw or shoulder;

  • prostate symptoms--increased urination (especially at night), loss of bladder control, very little urine or a weak stream of urine;

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • pain, swelling, or tenderness of your gums;

  • headache;

  • more frequent or prolonged erections;

  • altered sense of taste; or

  • bitter or unpleasant taste in the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Testosterone buccal system dosing information

Usual Adult Dose for Hypogonadism -- Male:

-Testosterone Undecanoate: 750 mg (3 mL) IM injection followed by 750 mg (3 mL) injected after 4 weeks, then 750 mg (3 mL) every 10 weeks thereafter
-Testosterone Enanthate and Cypionate: 50 to 400 mg IM injection every 2 to 4 weeks

-2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.
-The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate administered parenterally. Thus, implant two 75 mg pellets for each 25 mg testosterone propionate required weekly.

-The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.
-This drug should be used only if the benefits outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.
-Injections more frequently than every two weeks are not recommended.
-Adequate effect of the implants (pellets) continues for three to four months, sometimes as long as six months.

-Mucoadhesive Oral Patch: Apply a 30 mg patch to the gum region twice a day; morning and evening (about 12 hours apart).

-Transdermal Film: 2 to 6 mg applied to the back, abdomen, upper arm, or upper thigh once a day, preferably at night.
-Gel (in tubes, packets or spray): 5 g applied once a day, preferably in the morning. Consult the manufacturer product information for specific dosage and additional instructions of use.
-Transdermal Solution: Initial dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once a day, at the same time each morning. Consult the manufacturer product information for specific dosage and additional instructions of use.

Comments: Prior to initiating therapy with this drug, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days, and that these serum testosterone concentrations are below the normal range.

-Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.
-Hypogonadotropic hypogonadism (congenital or acquired): Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Usual Adult Dose for Breast Cancer--Palliative:

Testosterone Enanthate:
-200 to 400 mg IM injection every 2 to 4 weeks

-Androgen therapy can accelerate the disease. Close monitoring is recommended.
-Report any hoarseness, acne, changes in menstrual periods, or more facial hair.

-This drug may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal.
-Premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.

Usual Pediatric Dose for Delayed Puberty -- Male:

-Testosterone Enanthate: 50 to 200 mg every 2 to 4 weeks for 4 to 6 months

-2 pellets (each pellet contain 75 mg of testosterone) implanted subcutaneously every 3 to 6 months
-Duration of therapy: 4 to 6 months

-The chronological and skeletal ages should be taken into consideration when determining the initial dose and when adjusting the dose.
-An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers.
-Report frequent or persistent erections.
-Androgen therapy should be used very cautiously in children and only by specialists who are aware of the adverse effects on bone maturation.

Use: To stimulate puberty in selected males with clearly delayed puberty

What other drugs will affect testosterone buccal?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with testosterone buccal, especially:

  • insulin;

  • a blood thinner (warfarin, Coumadin, Jantoven); or

  • steroid medicine (dexamethasone, methylprednisolone, prednisone, and others).

This list is not complete. Other drugs may interact with testosterone buccal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about testosterone buccal.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision Date: 2015-06-14, 9:24:48 AM.