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 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 USES: 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.
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.
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, and trouble sleeping may also occur. If any of these effects persist or worsen, tell 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 right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), bleeding gums, mouth sores, very slow/shallow/difficult breathing (possibly while sleeping), breast enlargement/pain, 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, fast/irregular heartbeat.
Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.
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.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, male breast cancer, prostate problems (such as prostate cancer, enlarged prostate or benign prostatic hyperplasia-BPH), heart problems (such as congestive heart failure, coronary artery disease, heart attack), stroke, kidney problems, swelling (edema), ongoing lung disease, diabetes, high cholesterol level, difficulty breathing during sleep (apnea), obesity, high blood pressure, bone cancer, blood clots (such as in the leg, lungs).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
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 should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: "blood thinners" (such as warfarin).
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.
If overdose is suspected, contact a poison control center or emergency room right away. 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.
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.
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.
Store at room temperature away from light and moisture. If the blister package is damaged, do not use the tablet. Do not store in bathroom. Keep all medications 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.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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