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Read the Patient Information that comes with Striant [STRI´ ant] before you start using it and each time you get a refill. There may be new information. This information does not take the place of information from your healthcare provider about your medical condition or your treatment.
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 white to off-white tablet-like buccal system that is applied to the upper gum area of the mouth. Striant is not to be chewed or swallowed.
Striant is a controlled substance (CIII) because it contains testosterone. Therefore, you should keep your Striant in a secure place. Do not share or sell your Striant.
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 |
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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.
Use Striant twice a day, once in the morning and once at night (about 12
hours apart). You may find it convenient to apply morning dose after
brushing your teeth following breakfast and evening dose following your
evening meal.
Striant should be applied as follows:
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Tear off individual unit then start at the corner tab and peel off paper backing. Push buccal system through foil from the front. You will notice that
Striant is curved on one side and flat on the other side. The flat side has
a marking on it (company logo).
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Before you apply Striant, locate the area on your upper gum, just above
either the left or right incisor (see picture).
The incisor is the tooth just to the right or
left of your two front teeth. |
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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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Using your finger on the outside of
your upper lip, hold the Striant® buccal
system in place for 30 seconds (see
picture). This will make the buccal system
stick to your gum or cheek. |
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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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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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With each application, you should rotate Striant to alternate sides of your mouth.
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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.
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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.
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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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Check to see if Striant is in place following toothbrushing, use of mouthwash
and consumption of food or alcoholic/nonalcoholic beverages. If Striant does
not stick or falls off, follow the above mentioned directions to replace with a
new system.
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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 bowel movements (stool) turns 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. |
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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.
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 two 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. |
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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.
Keep Striant at a temperature between 68° and 77° F (20-25° C). Protect
from heat and moisture. Do not use a damaged blister package. Keep Striant
and all medicines out of the reach of children. Discarded Striant buccal
systems should be thrown away in a household trash can in a way that prevents
children or pets from accidentally using or taking them.
General information about the safe and effective use of Striant. Medicines
are sometimes prescribed for conditions that are not mentioned in patient
information leaflets. Do not use Striant for a condition for which it was not
prescribed. Do not give Striant to other people, even if they have the same
symptoms you have. It may harm them, and you should be aware that
Striant is a controlled substance.
This leaflet summarizes the most important information about Striant. If
you would like more information, talk with your doctor. You can ask your
doctor or pharmacist for information about Striant that is written for health
professionals.
What are the ingredients of Striant?
Active Ingredient: Testosterone USP (30 mg in each buccal system)
Inactive Ingredients: anhydrous lactose NF, carbomer 934P, hypromellose
USP, magnesium stearate NF, lactose monohydrate NF, polycarbophil USP,
colloidal silicon dioxide NF, starch NF, and talc USP.
Striant is supplied in a transparent blister in a white card. Each card
contains 10 buccal systems. There are a total of 6 blister cards (60 buccal
systems) in each carton.
Rx Only
Manufactured by: Mipharm S.p.A, Milan, Italy
Manufactured for: Columbia Laboratories, Inc., Livingston, NJ 07039
| US Patent Numbers : |
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6,248,358 |
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others pending |
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