GENERIC NAME: TESTOSTERONE SUSTAINED-RELEASE - BUCCAL (tess-TOSS-ter-own)
BRAND NAME(S): Striant
USES: This medication contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). This medication is absorbed through your gums, enters your bloodstream, and helps your body reach normal testosterone levels.Testosterone helps the body to produce sperm and to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss and is necessary for natural sexual ability/interest.This drug should not be used by women.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug, but may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used in boys to bring on puberty.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using testosterone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is absorbed into your body through your gums. Do not swallow or chew the tablet. Immediately after opening the packet, place the rounded side of the tablet in a comfortable area of the gum as high as it will go above the tooth (incisor) next to your front tooth. Hold the tablet in place for 30 seconds by pressing through your upper lip. This will help the tablet stick to your cheek/gum for 12 hours. Over time, the tablet will mold to your mouth. To remove, gently move the tablet back and forth until it loosens, then slide it down your tooth to avoid scratching your gums. Throw away the used tablet into the trash out of reach of children and pets. If you have any questions about how to use this product, consult your pharmacist.The tablet is usually changed twice a day, about every 12 hours. You should switch to the opposite side of your mouth each time you change the tablet. Inspect your gums regularly, and tell your doctor if anything looks abnormal.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day, usually after brushing your teeth in the morning and evening. Always check that the tablet is still stuck to your gum or cheek after eating, drinking, brushing teeth, or using mouthwash.If the tablet falls off, throw away the old tablet and place a new one. If it is more than 4 hours before your next scheduled dose, place a new tablet, and then change at your usual time. If it is less than 4 hours until you usually change tablets, place a new tablet and skip the next change time. Then resume your usual dosing schedule.If this tablet is accidentally swallowed, it is unlikely to cause problems because stomach acid will destroy most of the testosterone in this tablet. In case of swallowing, contact the doctor if there are any side effects.Inform your doctor if your condition persists or worsens.Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.
SIDE EFFECTS: Side effects in the mouth and gums may occur, including redness, irritation, pain, tenderness, swelling, and bitter/strange/change in taste. These effects usually go away within several days but may last up to 2 weeks. Headache, nausea, acne, change in sexual interest, hair loss, toothache, or trouble sleeping may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, anxiety), bleeding gums, mouth sores, trouble breathing (especially while sleeping), breast enlargement/pain.Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea/vomiting, dark urine, yellowing of eyes/skin, stomach/abdominal pain, swelling of ankles/feet, sudden weight gain, trouble urinating, painful ejaculation, bloody semen, frequent pain/stiffness in lower back/hips/thighs, testicle pain/tenderness, change in size/shape of the testicles.In patients with diabetes, especially those taking insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Symptoms of low blood sugar include shakiness, nervousness, fast heartbeat, and sweating. If you are experiencing these symptoms, consult your doctor. Your doctor may need to adjust your diabetes medications.In the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: male breast cancer, 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 benign prostatic hyperplasia-BPH), heart problems (e.g., congestive heart failure, coronary artery disease), kidney problems, swelling (edema), ongoing lung disease, diabetes, high cholesterol level, difficulty breathing during sleep (apnea), obesity, high blood pressure, bone cancer.Some men, particularly the elderly, are at a higher risk for developing enlarged prostates or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.Use extreme caution if using this drug in children because it might stunt the growth of the child. Monitor the child's growth rate carefully.This medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), corticosteroids (e.g., prednisone), oxyphenbutazone, propranolol, sodium fusidate.This medication may interfere with certain laboratory tests (including thyroid tests, creatinine levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of an overdose may include weakness on one side of the body, slurred speech, vision problems, confusion.
NOTES: Do not share this medication with others. It is against the law.Laboratory and/or medical tests (e.g., PSA, cholesterol, hematocrit, hemoglobin, testosterone blood levels, liver function tests, prostate exams) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.This medication has been prescribed for your current condition only. Do not use it later for another problem unless told to do so by your doctor. A different medication may be necessary in those cases.Inform all your doctors that you are using 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 your gum.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 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.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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