Striant

DRUG DESCRIPTION

Striant® (testosterone buccal system) 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. Insertion of Striant® (testosterone) twice a day, in the morning and in the evening, provides continuous systemic delivery of testosterone.

Striant® (testosterone) is a white to off-white colored, monoconvex, tablet-like, mucoadhesive buccal system. Striant® (testosterone) adheres to the gum tissue above the incisors, with the flat surface facing the cheek mucosa.

The active ingredient in Striant® is testosterone. Each buccal system contains 30 mg of testosterone. Testosterone USP is practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3one.

 STRIANT® (testosterone buccal) Structural Formula Illustration

C19H28O2          M.W.: 288.42

Other pharmacologically inactive ingredients in Striant® (testosterone) 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...

Read All Potential Side Effects and See Pictures of Striant »

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: male breast cancer, prostate cancer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, prostate problems (e.g., enlarged prostate or benign prostatic hyperplasia-BPH), heart problems (e.g., congestive heart failure, coronary artery disease), kidney problems, swelling (edema), ongoing lung...

Read All Potential Precautions of Striant »


Striant Consumer (continued)

SIDE EFFECTS: 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, or trouble sleeping may also occur. If any of these effects persist or worsen, notify 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, anxiety), bleeding gums, mouth sores, trouble breathing (especially while sleeping), breast enlargement/pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: 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.

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.

In the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: male breast cancer, prostate cancer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, prostate problems (e.g., enlarged prostate or benign prostatic hyperplasia-BPH), heart problems (e.g., congestive heart failure, coronary artery disease), kidney problems, swelling (edema), ongoing lung disease, diabetes, high cholesterol level, difficulty breathing during sleep (apnea), obesity, high blood pressure, bone cancer.

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 is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.


Striant Patient Information Including Side Effects

Brand Names: Striant

Generic Name: testosterone buccal system (Pronunciation: tes TOSS ter one)

  • What is testosterone buccal system (Striant)?
  • What are the possible side effects of testosterone buccal system (Striant)?
  • What is the most important information I should know about testosterone buccal system (Striant)?
  • What should I discuss with my healthcare provider before using testosterone buccal system (Striant)?
  • How should I use testosterone buccal system (Striant)?
  • What happens if I miss a dose (Striant)?
  • What happens if I overdose (Striant)?
  • What should I avoid while using testosterone buccal system (Striant)?
  • What other drugs will affect testosterone buccal system (Striant)?
  • Where can I get more information?

What is testosterone buccal system (Striant)?

Testosterone is a naturally occurring "male" sex hormone necessary for many processes in the body.

Testosterone buccal system is used to treat men with low testosterone levels.

Testosterone buccal system may also be used for purposes other than those listed in this medication guide.

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, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue); or
  • dark colored urine or problems with urination.

Other, less serious side effects may be more likely to occur. Continue to use testosterone buccal system and talk to your doctor if you experience

  • irritation or changes in the gum at the system application site;
  • bitter or unusual taste in the mouth;
  • headache;
  • emotional changes;
  • increased blood pressure;
  • decreased interest in sex;
  • changes in blood cholesterol or number of red blood cells (detected by blood tests);
  • prostate changes or difficulty urinating;
  • enlarged, swollen or tender breasts; or
  • acne.

Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about testosterone buccal system (Striant)?

Notify your doctor if you experience nausea; vomiting; swelling of the ankles; changes in skin color; too frequent or prolonged erections; breathing disturbances, including those associated with sleep; yellowing of the skin or eyes; dark colored urine; or problems with urination.

Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

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