Striant

Name: Striant

What happens if i miss a dose (striant)?

Apply the next system as soon as you remember. Do not use two doses simultaneously, unless otherwise directed by your doctor.

Manufacturer

  • Actient Pharmaceuticals, LLC.

  • Columbia Laboratories, Inc.

Side Effects of Striant

Serious side effects have been reported with testosterone. See the “Testosterone Precautions” section.

Topical:

Common side effects of topical testosterone include the following:

  • Breast enlargement
  • Decreased sexual desire
  • Acne
  • Hair loss
  • Hot flashes
  • Depression
  • Changes in mood
  • Nervousness
  • Headache
  • Weakness
  • Insomnia
  • Dry skin
  • Changes in the ability to taste or smell
  • Skin irritation at the site of application

Injectable:

Common side effects of injectable testosterone include the following:

  • Nausea and vomiting
  • Changes in skin color
  • Ankle swelling
  • Increased calcium levels in the blood
  • Enlarged breasts
  • Enlarged prostate in men
  • Deepening of the voice, the appearance of facial hair, and acne in women

This is not a complete list of testosterone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Inform MD

Before taking testosterone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to testosterone or to any of its ingredients
  • have or have had prostate cancer or an enlarged prostate
  • have or have had breast cancer
  • have sleep apnea
  • have heart problems
  • have diabetes
  • have kidney disease
  • have lung disease
  • have liver disease
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Striant Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your age
  • your gender

Topical:

The recommended dose of testosterone gel for the treatment of hypogonadism in males is 50 to 100 mg daily applied to the skin. The recommended dose of the nasal formulation of testosterone is 11 mg daily. The recommended dose of the buccal system of testosterone is 30 mg twice daily. The recommended dose of the testosterone transdermal patch is 4 to 6 mg daily.

Injectable:

The recommended dose of testosterone for the treatment of hypogonadism in males is 50 to 400 mg every 2 to 4 weeks.

The recommended dose of testosterone for the treatment of delayed puberty in adolescent males is 50 to 200 mg every 2 to 4 weeks for 4 to 6 months.

 

Striant Overdose

If you take too much testosterone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If testosterone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

How is this medicine (Striant) best taken?

Use Striant as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Striant.
  • Wash your hands before and after use.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not take this medicine out of the blister pack until you are ready to take it. Take Striant (testosterone buccal system) right away after opening the blister pack. Do not store the removed drug for future use.
  • Dry your hands and place the tablet in your mouth above the incisor tooth between the upper cheek and gum. Let it melt during the day.
  • Do not chew or swallow.
  • Change the side of mouth with each dose.
  • Do not take out until it is time for your next dose.
  • Make sure drug is still in place after eating, drinking, brushing your teeth, or using mouthwash.
  • If the drug does not stick or falls out, follow what your doctor has told you or read the package insert. If you are not sure what to do, talk with your doctor.
  • To remove tablet, gently slide it down from the gum toward the tooth to keep from scratching the gum.

What do I do if I miss a dose?

  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses or extra doses.

What are some other side effects of Striant?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Pimples (acne).
  • Loose stools (diarrhea).
  • Emotional ups and downs.
  • Change in sex interest.
  • Change in sex ability.
  • Feeling tired or weak.
  • Not able to sleep.
  • Irritation where Striant is used.
  • Change in taste.
  • Bad taste in your mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Contraindications

  • Striant is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
  • Striant is contraindicated in women who are or may become pregnant, or who are breastfeeding. Striant may cause fetal harm when administered to a pregnant woman. Striant may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization [see Use in Specific Populations (8.1, 8.3)].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.

Mutagenesis

Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.

Impairment of Fertility

The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non human primates, which was reversible on cessation of the treatment.

Clinical Studies

Clinical Trials in Adult Hypogonadal Males

Striant was evaluated in a multicenter, open-label Phase 3 trial in 98 hypogonadal men. In this study, 30 mg of Striant was administered buccally twice daily for 12 weeks. The mean age was 53.6 years (range 20 to 75 years). Overall, 69% of patients were Caucasian, 9% were African-American, 15% were Hispanic, 4% were Asian, and 2% were of another ethnic origin. At baseline, 10% of patients reported current use of tobacco and 42% drank alcohol.

Of 82 patients who completed the trial and had sufficient data for full analysis, 86.6% had mean serum testosterone concentration (Cavg(0-24)) values within the physiologic range (300-1050 ng/dL).

The mean (±SD) time-averaged steady-state daily testosterone concentration (Cavg(0-24)) at Day 84 was 520 (±205) ng/dL compared with a mean of 149 (±99) ng/dL at Baseline. The mean (±SD) maximum testosterone concentration (Cmax) at Day 84 was 970 (±442) ng/dL. At Day 84, the mean percentage of time over the 24-hour sampling period that total testosterone concentrations remained within the normal range of 300-1050 ng/dL was 76%.

Figure 3 shows the mean total testosterone serum concentration versus time curves on Day 84 (after 12 weeks of Striant treatment).

Figure 3. Mean (SD) total testosterone concentration-time curves on Day 84 (after 12 weeks of Striant treatment, n=82)

Mean DHT concentrations increased in parallel with testosterone concentrations, with the total testosterone/DHT ratio (9-12) indicating no alteration in metabolism of testosterone to DHT in testosterone deficient men treated with Striant.

During continuous treatment there was no accumulation of testosterone, and mean total testosterone, free testosterone, and DHT were maintained within their physiologic ranges.

Before taking this medicine

You should not use Striant if you have ever had an allergic reaction to a testosterone product, or if you have:

  • prostate cancer; or

  • male breast cancer.

To make sure Striant is safe for you, tell your doctor if you have:

  • heart disease, history of heart attack or stroke;

  • a history of blood clots;

  • sleep apnea (breathing stops during sleep), or risk factors such as chronic lung disease, or being overweight;

  • liver or kidney disease;

  • urination problems, enlarged prostate; or

  • if you use a blood thinner such as warfarin, and you have routine "INR" or prothrombin time tests.

Striant should not be used by a woman. Testosterone could cause birth defects in an unborn baby if the mother uses this medicine during pregnancy. Testosterone can also cause serious side effects in a nursing baby if the mother uses the medicine while breast-feeding.

Striant is not approved for use by anyone younger than 18 years old.

For the Consumer

Applies to testosterone: buccal patch extended release

Other dosage forms:

  • intramuscular injectable, intramuscular oil, intramuscular solution, intramuscular suspension
  • nasal gel/jelly
  • transdermal patch extended release

Along with its needed effects, testosterone (the active ingredient contained in Striant) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking testosterone:

Incidence not known
  • Pain, redness, or swelling in the arm or leg
  • trouble breathing

Get emergency help immediately if any of the following symptoms of overdose occur while taking testosterone:

Symptoms of overdose
  • Blurred vision
  • headache
  • seizures
  • slurred speech
  • sudden and severe inability to speak
  • temporary blindness
  • weakness in the arm or leg on one side of the body, sudden and severe

Some side effects of testosterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Gum or mouth irritation
Less common
  • Bad, unusual, or unpleasant (after) taste
  • bleeding gums
  • blemishes on the skin
  • breast pain
  • change in taste
  • cough
  • crying
  • depersonalization
  • diarrhea
  • discouragement
  • dizziness
  • dry mouth
  • dysphoria
  • enlarged breasts
  • euphoria
  • fear or nervousness
  • feeling sad or empty
  • gum pain or blisters
  • hoarseness
  • indigestion
  • irritability
  • itching skin
  • loss of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • mouth ulcers
  • nausea
  • noisy breathing
  • painful or difficult urination
  • paranoia
  • passing of gas
  • pounding in the ears
  • quick to react or overreact emotionally
  • rapidly changing moods
  • redness and swelling of the gums
  • slow or fast heartbeat
  • stinging of the lips
  • stomach cramps, pain, fullness, or discomfort
  • swelling of the gums
  • swelling of the nose
  • tiredness
  • toothache
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

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