Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

TESTOSTERONE - BUCCAL SUSTAINED RELEASE

(tess-TOSS-ter-own)

COMMON BRAND NAME(S): Striant

Uses

Testosterone is used to treat men with conditions of low testosterone hormone levels (e.g., hypogonadism). This drug should not be used in women.

How To Use

This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. The tablet should be placed in a comfortable area of the gums just above one of your upper front teeth (incisor) usually twice a day, morning and evening (about 12 hours apart), or as directed. You should switch to the opposite side of the mouth with each new tablet that you use. Do not swallow or chew the tablet. Immediately after opening the packet, place the rounded side of the tablet against the gum and press firmly in place with a finger over the lip and against the product for 30 seconds. This will help keep the tablet in place inside your mouth for 12 hours. To remove, simply slide the tablet down towards the tooth to avoid scratching the gum. Discard the old tablet into the trash. If you have any questions about how to use this product, consult your pharmacist. Try to keep the tablet from slipping off of your gum. Always check that the tablet is still on your gum after eating, drinking, brushing teeth, or using mouthwash. If the tablet falls off of your gum, throw away the old tablet and place a new tablet on your gum. Remove this tablet at your next usual change time. If the tablet falls off less than four hours before your next change time, place a new tablet and skip the next usual dose. Then resume your usual dosing schedule.

Side Effects

Gum irritation, pain, tenderness or swelling may occur. If these effects persist or worsen, or if any other changes to your gums occurs, notify your doctor or pharmacist promptly. Nausea, bitter taste or unusual taste, headache, fatigue, hair loss, change in sexual drive, or acne may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: swelling (edema), trouble breathing (including very slow or shallow breathing), trouble urinating. Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness, breast pain or enlargement, mental/mood changes (e.g., anxiety, depression), weight gain, change in size or shape of the testicles. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: stomach pain, yellowing of the eyes or skin, dark urine. In the unlikely event you have a painful, prolonged erection, stop using this drug and seek immediate medical attention or permanent problems could occur. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, severe swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer (males), prostate cancer. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, prostate problems (e.g., enlarged prostate or BPH), heart problems (e.g., congestive heart failure, coronary artery disease), kidney problems, swelling (edema), chronic lung disease, diabetes, high cholesterol level, difficulty breathing during sleep (apnea), obesity, high blood pressure, any allergies (especially to soy). Geriatric men are at higher risk for developing enlarged prostates or prostate cancer when using this medication. Use in children should be undertaken with extreme caution since this drug may have undesirable effects related to the growth of the child. This medication should not be used in women, especially pregnant or breast-feeding women. This drug has been shown to cause fetal harm. It is unknown if this medication passes into breast milk. Because this medication may have serious, harmful effects on a nursing infant, breast-feeding is not recommended. Consult your doctor.

Drug Interactions

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: corticosteroids (e.g., prednisone), insulin, oral diabetes medication (e.g., glyburide, metformin), oxyphenbutazone, "blood thinners" (e.g., warfarin). This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of an overdose may include one-sided weakness, vision problems, or confusion.

Notes

Do not share this medication with others; it is against the law. Laboratory and/or medical tests (e.g., PSA, testosterone levels, red blood cell count, liver function tests, cholesterol) should be performed to monitor your progress or check for side effects. Consult your doctor for more details. Inform all your doctors you use (or have used) this medication.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. See How To Use section for what to do if your tablet falls off of your gum.

Storage

Store at room temperature between 68 and 77 degrees F (20 and 25 degrees C) away from light and moisture. If the blister package is damaged, do not use the tablet. Do not store in bathroom. Keep all medicines away from children and pets.