"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
(testosterone buccal system) Mucoadhesive
Striant (testosterone buccal system) mucoadhesive is for buccal administration only. It contains testosterone, an androgen.
Striant is designed to adhere to the gum or inner cheek. It provides a controlled and sustained release of testosterone through the buccal mucosa as the buccal system gradually hydrates. Application of Striant twice a day, in the morning and in the evening, provides continuous systemic delivery of testosterone.
Striant is a white to off-white colored, monoconvex, tablet-like, mucoadhesive buccal system. Striant adheres to the gum tissue above the incisors, with the flat surface facing the cheek mucosa.
The active ingredient in Striant is testosterone (see Figure 1). Each buccal system contains 30 mg of testosterone. Testosterone USP is practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3one.
Figure 1: Chemical Structure of Testosterone
Other pharmacologically inactive ingredients in Striant 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.
What are the possible side effects of testosterone buccal system (Striant)?
If you experience any of the following serious side effects, stop using testosterone buccal system and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- nausea or vomiting;
- changes in skin color;
- swelling of the ankles or legs;
- breathing disturbances, including those associated with sleep;
- too frequent or prolonged erections;
- liver damage (yellowing of the skin or eyes, nausea,...
What are the precautions when taking testosterone (Striant)?
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,...
Last reviewed on RxList: 11/9/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Striant Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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