Striant - Consumer Medicine Information
|Manufacture:||Endo Pharmaceuticals Inc.|
|Class:||Androgens and anabolic steroids|
|Form:||Skin patch (transdermal)|
|Ingredients:||testosterone,anhydrous lactose NF, carbomer 934P, hypromellose USP, magnesium stearate NF, lactose monohydrate NF, polycarbophil USP, colloidal silicon dioxide NF, starch NF, and talc USP.|
(testosterone buccal system)
What is Striant
Striant is prescription medicine that contains testosterone. Striant is used to treat adult males who have low or no testosterone due to certain medical conditions.
Your healthcare provider will test your blood for testosterone before you start and while you are using Striant.
It is not known if Striant is safe or effective to treat men who have low testosterone due to aging.
It is not known if Striant is safe and effective in children younger than 18 years old. Improper use of testosterone may affect bone growth in children.
Striant is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Striant in a safe place to protect it. Never give your Striant to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.
Striant is not meant for use by women.
Who Should not use Striant
Do not use Striant if you:
- are a man who has breast cancer
- have or might have prostate cancer
- are pregnant or may become pregnant or are breastfeeding. Striant may harm your unborn or breastfeeding baby.
Talk to your healthcare provider before using this medicine if you have any of the above conditions.
What Should I Tell my Healthcare Provider Before Using Striant
Before you use Striant, tell your healthcare provider if you:
- have breast cancer
- have or might have prostate cancer
- have problems urinating due to an enlarged prostate
- have heart problems
- have kidney or liver problems
- have problems breathing while you sleep (sleep apnea)
- have diabetes
- have any other medical conditions
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Using Striant with other medicines can affect each other. Especially tell your healthcare provider if you take:
- medicines that decrease blood clotting
Know the medicines you take. Ask your healthcare provider or pharmacist for a list of all your medicines if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How Should I use Striant
- Apply Striant exactly as your healthcare provider tells you to.
- Striant is applied 1 time in the morning (after your routine oral care) and 1 time in the evening (about 12 hours apart).
- Change (rotate) your application site to the other side of your mouth with each application.
- Striant should stay on the application site until you take it off. If your Striant becomes loose or falls off, throw it away and put on a new one.
- Check to make sure that Striant is still in place after you brush your teeth, use mouthwash, or have anything to eat or drink.
- Do not chew or swallow Striant.
- 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.
- Striant is to be applied to your upper gum, just above either the left or right incisor tooth. The incisor is the tooth just to the right or left of your 2 front teeth.
- Remove your Striant from the package. Tear off 1 Striant. Start at the corner tab and peel off paper backing (See Figure A).
- Push Striant through the foil from the front (See Figure B).
- Check Striant. Striant is curved on one side and flat on the other side. The flat side has the letter “A” marked on it (See Figure C).
- Apply Striant. Place the flat side of the Striant on your fingertip (See Figure D).
- Gently place the curved side of Striant against your upper gum, then push Striant up as high as it will go on your gum (See Figure E).
- The flat side of Striant should be facing your cheek.
- Hold Striant in place for 30 seconds. Using your finger, push down on the outside of your upper lip over the application site for 30 seconds (See Figure F). This will help Striant to stick to the application site.
What are the Possible Side Effects of Striant
Striant can cause serious side effects including:
- Gum problems. Striant can cause severe gum irritation. You should check your gums often and tell your healthcare provider right away if you notice any signs of gum problems.
- If you already have an enlargement of your prostate gland, your signs and symptoms may get worse while using Striant. This can include:
- increased urination at night
- trouble starting your urine stream
- having to pass urine many times during the day
- having an urge that you have to go to the bathroom right away
- having a urine accident
- being unable to pass urine or weak urine flow
- Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or other prostate problems before you start and while you use Striant.
- Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
- Possible increased risk of heart attack or stroke.
- In large doses Striant may lower your sperm count.
- Swelling of your ankles, feet or body, with or without heart failure
- Enlarged or painful breasts
- Problems breathing while you sleep (sleep apnea).
Tell your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of Striant include:
- a change in how food tastes to you or an unusual or bitter taste in your mouth
- gum pain, tenderness, or swelling
Other side effects include more erections than are normal for you or erections that last a long time.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Striant. For more information, ask your healthcare provider or pharmacist.
How Should I Store Striant
- Keep Striant at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep Striant dry and away from heat.
- Do not use a damaged blister package. If your Striant blister package is damaged, throw it away and get a new one.
- Safely throw away your used Striant in the household trash.
Keep Striant and all medicines out of the reach of children and pets.
General Information About the Safe and Effective use of Striant.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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.
This Patient Information leaflet summarizes the most important information about Striant. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Striant that is written for health professionals.
For more information go to www.striant.com or call 1-877-663-0412
What are the Ingredients in Striant
Active Ingredient: testosterone
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.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured by: Mipharm S.p.A, Milan, Italy
Manufactured for: Actient Pharmaceuticals LLC, Malvern, PA 19355 US Patent No. 6,248,358