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testosterone buccal system

Pronunciation

Generic Name: testosterone buccal system (tes TOSS ter one)
Brand Name: Striant

What is testosterone buccal system?

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

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

Testosterone buccal system may also be used for purposes other than those listed in this medication guide.

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

Notify your doctor if you experience nausea; vomiting; swelling of the ankles; changes in skin color; too frequent or prolonged erections; breathing disturbances, including those associated with sleep; yellowing of the skin or eyes; dark colored urine; or problems with urination.

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Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

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

Do not use testosterone buccal system if you have cancer of the breast or prostate. Testosterone may worsen some cancers of these types.

Before using testosterone buccal system, tell your doctor if you have

  • had a previous allergic reaction to testosterone;

  • diabetes;

  • sleep apnea (brief periods of not breathing during sleep) or if you have risk factors for sleep apnea (e.g., obesity, chronic lung disease);

  • difficulty with urination due to enlargement of the prostate;

  • heart disease; or

  • liver disease or kidney disease.

You may not be able to use testosterone buccal system, or you may need a dosage adjustment or special monitoring if you have any of the conditions listed above.

Testosterone buccal system is not approved for use by women and must not be used by women. Testosterone buccal system is in the FDA pregnancy category X. This means that testosterone is known to cause birth defects in an unborn baby. Do not use testosterone buccal system if you are pregnant or could become pregnant during treatment.

Testosterone buccal system is not approved for use by women and must not be used by women. It is not known whether testosterone from the buccal system will pass into breast milk. Do not use testosterone buccal system if you are breast-feeding a baby.

Men over 65 years of age that use testosterone buccal system may be at increased risk for the development of prostatic enlargement or cancer. You may not be able to use buccal system testosterone, or you may require a lower dose or special monitoring.

How should I use testosterone buccal system?

Use testosterone buccal system exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To use the testosterone buccal system (Striant):

  • Hold one buccal system with the flat side on your fingertip. Place the curved side onto your gum, as high as possible above the left or right incisor tooth. Hold your finger on the outside of your lip over the system for 30 seconds to ensure the system is attached to the gum. If the system sticks to the cheek and not the gum, this is acceptable.

  • The buccal system should remain in place for 12 hours. To remove the system, move it slightly toward the back or front of the mouth then slide it toward the teeth from removal. With each new application, rotate to alternate sides of the mouth. This avoids scratching the gum. Check to see that the system is in place after eating, drinking, brushing the teeth, or using mouthwash.

  • As the buccal system absorbs moisture from the mouth, it will begin to soften and will mold to the shape of the gum. The system does not dissolve completely, but will remain in place. It will not move until you remove it.

  • If a buccal system falls off before 8 hours of use, remove it and replace it with a new system in the same place.

  • Change the buccal system and alternate sides of the mouth 12 hours after application of the original system. If a buccal system falls off after 8 hours but before 12 hours of use, remove the system and replace it with a new system above the opposite incisor. This will serve as the second dose for the day.

  • Do not chew or swallow the testosterone buccal system.

  • Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Your doctor may want to perform tests to monitor the amount of testosterone in the body, liver function, prostate function, cholesterol levels, or other factors during treatment with testosterone buccal system.

It is important to use testosterone buccal system regularly to get the most benefit.

Dispose of all used systems properly, out of the reach of children and pets.

Store testosterone buccal system at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the next system as soon as you remember. Do not use two doses simultaneously, unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of testosterone buccal system is not likely to threaten life. If you do suspect an overdose, or if a system has been ingested, call an emergency room or poison control center for advice.

What should I avoid while using testosterone buccal system?

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Testosterone buccal system side effects

If you experience any of the following serious side effects, stop using testosterone buccal system and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; 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, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue); or

  • dark colored urine or problems with urination.

Other, less serious side effects may be more likely to occur. Continue to use testosterone buccal system and talk to your doctor if you experience

  • irritation or changes in the gum at the system application site;

  • bitter or unusual taste in the mouth;

  • headache;

  • emotional changes;

  • increased blood pressure;

  • decreased interest in sex;

  • changes in blood cholesterol or number of red blood cells (detected by blood tests);

  • prostate changes or difficulty urinating;

  • enlarged, swollen or tender breasts; or

  • acne.

Notify 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 other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. 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:

Parenteral: Short-acting (testosterone solution and propionate): 25 mg to 50 mg IM 2 to 3 times a week.
Long-acting (enanthate and cypionate): 50 to 400 mg IM every 2 to 4 weeks.
Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.

Topical:
Transdermal Film: 2.5 to 5 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 daily, preferably in the morning. May increase as needed to a maximum of 10 g once a day.

Buccal: 30 mg patch to the gum region twice daily; morning and evening (about 12 hours apart). Patch should be placed just above the incisor tooth. With each application, the patch should be rotated to alternate sided of the mouth.

Testosterone 30 mg/1.5 mL transdermal solution:
Starting dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once daily, at the same time each morning. The dose of testosterone may be decreased from 60 mg (2 pump actuations) to 30 mg (1 pump actuation) or increased from 60 mg to 90 mg (3 pump actuations) or from 90 mg to 120 mg (4 pump actuations) based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying the solution and at least 14 days after starting treatment or following dose adjustment.

Testosterone 10 mg/0.5 g transdermal gel:
Starting dose is 40 mg of testosterone (4 pump actuations of 30 mg to clean, dry intact skin of the front and inner thighs), applied once daily, at the same time each morning. Let application site dry before putting on pants or shorts. The dose can be adjusted between a minimum of 10 mg of testosterone (1 pump actuation) and a maximum of 70 mg of testosterone (7 pump actuations) on the basis of total serum testosterone concentrations 2 hours post application. The dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying and at approximately 14 days and 35 days after starting treatment or following dose adjustment. In addition, serum testosterone concentration should be assessed periodically thereafter.

Testosterone 20.25 mg/1.25 g transdermal gel:
Starting dose 40.5 mg of testosterone (2 pump actuations), applied topically to the shoulders and upper arms once daily in the morning. The dose can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations). The dose should be titrated based on the pre dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment. Additionally, serum testosterone concentration should be assessed periodically thereafter.

Usual Adult Dose for Breast Cancer--Palliative:

Parenteral: Short-acting (testosterone solution and propionate): 50 mg to 100 mg IM 2 to 3 times a week.
Long-acting (enanthate and cypionate): 200 to 400 mg IM every 2 to 4 weeks.
Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months

Testosterone is approved by the FDA for the palliation of androgen responsive metastatic breast cancer in women who are 1 to 5 years postmenopausal or who are proven to have a hormone-dependent tumor noted by previous beneficial response to castration.

Female patients should be observed for signs of virilization. Women should be instructed to report any hoarseness, acne, changes in menstrual periods, or increases in facial hair. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made by the patient and the physician that some virilization will be tolerated during the treatment for malignant disease.

Usual Adult Dose for Postpartum Breast Pain:

Parenteral: Short-acting (testosterone solution and propionate): 25 mg to 50 mg IM for 3 to 4 days, starting at the time of delivery.

Usual Pediatric Dose for Delayed Puberty -- Male:

Parenteral:
Initiation of pubertal growth: Long-acting (enanthate and cypionate): 40 to 50 mg/square meter IM monthly until the growth rate falls to prepubertal levels.
Terminal growth phase: Long-acting (enanthate and cypionate): 100 mg/square meter IM monthly until the growth ceases.
Maintenance virilizing dose: Long-acting (enanthate and cypionate): 100 mg/square meter intramuscular twice monthly.

Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.

Dosages used to treat delayed puberty are generally started at the lower end of the dosing range and titrated according to patient response and tolerance. The duration of therapy should be limited to 4 to 6 months. Serum concentrations of testosterone should be determined following 3 to 4 weeks of daily use. If desired results have not been achieved at 6 to 8 weeks an alternative testosterone regimen should be considered.

Wrist and hand bone age should be assessed prior to initiation of testosterone therapy and every 6 months to monitor bone maturation. Exogenous androgen therapy can accelerate bone maturation without producing a compensatory gain in linear growth. Use over long periods can result in fusion of the epiphyseal growth centers and termination of the growth process.

What other drugs will affect testosterone buccal system?

Before using testosterone buccal system, tell your doctor if you are taking any of the following medicines:

  • warfarin (Coumadin);

  • insulin or an oral diabetes medication such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), repaglinide (Prandin), rosiglitazone (Avandia), pioglitazone (Actos), and others;

  • propranolol (Inderal, Inderal LA, others); or

  • a corticosteroid such as hydrocortisone (Cortef, Hydrocortone, Solu-Cortef), dexamethasone (Decadron, Hexadrol others), methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisolone (Prelone, Pediapred), prednisone (Deltasone, Orasone, others), and others.

You may not be able to use testosterone buccal system, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with testosterone buccal system. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

  • Your pharmacist has additional information about testosterone buccal system written for health professionals that you may read.
  • 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: 3.04. Revision Date: 2012-06-16, 8:26:57 PM.

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