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STRIANT is a hormone medicine that contains testosterone. It is used to treat adult men when their bodies do not make any testosterone or not enough testosterone (hypogonadism). STRIANT is a patented delivery method for providing you with a continuous level of the male hormone testosterone. Your doctor prescribed STRIANT because your body is not producing enough testosterone, so replacement therapy is needed. Some of the symptoms of low testosterone may include:
| ■ Inability to have sexual intercourse |
■ Low sexual desire |
| ■ Tiredness or loss of energy |
■ Mood depression |
| ■ Reduced beard or body hair growth |
■ Loss of muscle size and tone |
| ■ Osteoporosis (fragile bones) |
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Men with low testosterone will often experience one or more of these symptoms (but not necessarily all). Testosterone supplementation is prescribed to help restore normal levels of testosterone to the body.
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STRIANT is a unique system for providing testosterone to your body. It is a very small tablet-like product that you put in a comfortable position between your cheek and gum. Once there, STRIANT gradually releases testosterone that is absorbed into your bloodstream through your cheek and gum. This type of medication delivery is called “buccal” (BUCK-al) delivery. STRIANT should not be swallowed because testosterone is broken down by the digestive system and would not be useful to the body.
STRIANT is applied twice daily. This twice-a-day dosing allows it to keep your body’s testosterone at normal levels throughout the day. STRIANT delivers amounts of testosterone to your body that approximate amounts seen in healthy young men.
Placed properly, the buccal system will soften, producing a gel-like form that remains in place over each 12-hour dosing period. STRIANT is designed to stick to the tissue of your gum or cheek as it absorbs moisture. It will stay in place, gradually releasing testosterone that is absorbed through your gum and cheek directly into your bloodstream.
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Top Carefully read the following instructions for “How to use STRIANT,” and if possible, review them with your health care provider. Apply STRIANT to the proper spot on the upper gum twice a day— once in the morning and once in the evening (about 12 hours apart). You may find it convenient to apply the morning dose after brushing your teeth following breakfast, and the evening dose following your evening meal. It is recommended that STRIANT be placed on alternate sides of the mouth with each application.
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Remove the product
Push one STRIANT buccal system out of the backside of the blister card. You will notice that STRIANT is curved on one side and flat on the other side. The flat side has a marking on it.
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Find the right location
Before you apply STRIANT, locate the area on your upper gum, just above either the left or right incisor (see picture at right, below). The incisor is the tooth just to the right or left of your two front teeth.
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Apply STRIANT
Place the flat side of the STRIANT system on your fingertip. Gently push the curved side of STRIANT against your upper gum in the area shown. Push the STRIANT system up as high as it will go on the gum. If you have applied STRIANT correctly, the flat side will be facing your cheek.
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Hold in place for 30 seconds
Using your finger on the outside of your upper lip, hold the STRIANT buccal system in place for 30 seconds (see picture at right). This will make the buccal system stick to your gum or cheek. As the STRIANT buccal system absorbs moisture< from your mouth, it will begin to soften and will mold to the shape of your gum. You should be aware that STRIANT does not dissolve completely, but will remain in place for 12 hours. STRIANT is made to stay in place until you remove it.
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| Click here to see an amination about Striant |
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If it falls off within the first 8 hours: If STRIANT does not stick or falls off within the first 8 hours, remove the original system and apply a new one. This counts as replacing the first dose. Apply the next system about 12 hours after the original buccal system was applied. If it falls off after more than 8 hours: If STRIANT falls off after 8 hours but before 12 hours, replace the original buccal system. This replacement can serve as the second dose for that day. Check to see if STRIANT is in place following tooth brushing, use of mouthwash, and consumption of food or alcoholic/nonalcoholic beverages. If STRIANT does not stick or falls off, follow the abovementioned directions to replace with a new system. If STRIANT sticks to your cheek and not your gum, this is acceptable. Do not replace the buccal system if this should happen.
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If you miss a dose, just begin again with your next scheduled dose.Do not try to make up for your missed dose.
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If placed properly, eating and drinking should not affect STRIANT. Check to see if STRIANT is in place following consumption of food or beverages. If STRIANT does not stick or falls off, follow the previously mentioned directions to replace with a new system.
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Yes. STRIANT is designed to be used and stay in place while you are sleeping. It is necessary that you keep STRIANT in place overnight to get the testosterone you need.
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STRIANT should not be chewed or swallowed. If it happens accidentally, testosterone that is swallowed is not expected to enter your bloodstream in significant amounts because it is quickly broken down by your digestive system. However, if you should experience an adverse effect, please contact your doctor. Replace STRIANT as directed previously in “What if STRIANT falls off before it is time to remove it?”
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STRIANT is a solid tablet-like product that slowly absorbs moisture from the outside in. As this happens, STRIANT will begin to soften and will mold to the shape of your gum. You should be aware that STRIANT does not dissolve completely, but will remain in place for 12 hours. When it’s time for a new dose, simply remove any leftover product. You can use a toothbrush to clean away the residue or remove STRIANT by gently sliding it to the front or back of your mouth to loosen it. Then slide it downwards from your gum to your tooth. This will avoid scratching the gum.
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You should discuss your STRIANT therapy with your dental professional.
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STRIANT should not get in the way of kissing or intimate activities.
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Yes. It is important to take STRIANT continuously, as prescribed by your doctor, twice a day. This ensures that you are getting the levels of testosterone you need.
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No. You should take STRIANT as directed, one STRIANT, two times a day.
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Do not use STRIANT if you:
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Have breast cancer (rare in men) |
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Have prostate cancer |
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Are a woman (especially if you are pregnant or breast-feeding). STRIANT may harm the babies of pregnant and breast-feeding women |
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Are allergic to STRIANT. The active ingredient in STRIANT is testosterone USP. See the end of this leaflet for a list of all ingredients in STRIANT |
Tell your doctor if you have or had:
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Problems urinating due to an enlarged prostate |
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Liver problems |
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Kidney problems |
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Heart problems |
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Lung problems |
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Diabetes |
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Weight problems (obesity) |
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may cause serious side effects if taken while you also take STRIANT. Some medicines may affect how STRIANT works, or STRIANT may affect how your other medicines work. Be sure to tell your doctor if you use insulin for diabetes. Your dose of insulin may need to be adjusted if you use STRIANT.
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Inform your doctor immediately if any of the following symptoms appear while using STRIANT.
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Liver problems. Tell your doctor if: |
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— Your skin or white part of your eyes turns yellow (jaundice) |
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— Your urine turns dark |
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— Your bowel movements (stool) turn light in color |
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— You don’t feel like eating for several days or longer |
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— You feel sick to your stomach (nausea) |
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— You have lower abdominal pain (stomach) |
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Problems urinating—tell your doctor if you develop problems urinating while using STRIANT. Older patients who use testosterone replacement therapies may have an increased chance of developing prostate enlargement or prostate cancer |
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Extra fluid in the body (edema)—edema can be dangerous if you have heart, kidney, or liver problems. Tell your doctor if your ankles and legs swell or if you put on weight quickly |
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Breathing problems, including a sleep problem called “sleep apnea”—sleep apnea is when you stop breathing for short times while you are sleeping. This happens more in patients who are overweight or who have lung disease. Tell your doctor if you have breathing problems or if you or your partner notice changes in your breathing when you are sleeping |
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Penile erections that are painful, that occur too frequently, or that last for too long a duration |
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Breast enlargement—which sometimes does not go away |
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Emotional changes—such as depression Your doctor may do blood tests to check your red blood cells, liver function, cholesterol levels, testosterone levels, and prostate (PSA) while you are using STRIANT to see how STRIANT is affecting your body. |
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STRIANT may also cause these side effects:
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Redness, irritation, swelling, and pain at the gum application site |
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Gum infection (gingivitis)—gum side effects are usually temporary and should resolve within several days. However, some gum side effects may last up to 2 weeks. If you should have gum side effects, they usually resolve while taking STRIANT. Any abnormal finding should be brought to the attention of your physician |
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A change in how food tastes to you, a bitter taste in your mouth, or an unusual taste in your mouth |
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Headache These are not all the possible side effects of STRIANT. For more information, ask your doctor or pharmacist.You should regularly examine your gums where STRIANT is applied. Any abnormal finding should be brought to the attention of your physician. |
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STRIANT is a white to off-white tablet-like product that is curved on one side and flat on the other. The company logo  is on the flat side.
STRIANT buccal system comes in transparent white blister cards containing 10 buccal systems, and there are 6 blister cards in each carton. Therefore each carton contains 60 buccal systems. Taken twice a day, this represents a 30-day supply. Store STRIANT at room temperature (68°F–77°F). Protect from heat and moisture. Damaged blister packs should not be used. The product should not be taken after the expiration date. The active ingredient in STRIANT is testosterone USP (30 mg in each buccal system). The inactive ingredients are: anhydrous lactose NF, carbomer 934P, hypromellose USP, magnesium stearate NF, lactose monohydrate NF, polycarbophil USP, colloidal silicon dioxide NF, starch NF, and talc USP.
Keep STRIANT and all medicines out of the reach of children.
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STRIANT is available by prescription only. STRIANT is a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. This means that testosterone has a potential for abuse that may lead to moderate or low physical dependence or high psychological dependence. Do not give STRIANT to other people, even if they have the same symptoms as you do.
Discarded product should be thrown away in a household trash can in a way that prevents children or pets from accidentally using or taking the product.
Please talk with your doctor regarding any questions or concerns you may have. This starter kit cannot take the place of a patient-physician discussion. The enclosed Patient Leaflet lists some symptoms to watch out for, and you should contact your physician immediately if they occur. Call 1-866-STRIANT (787-4268).
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