Testosterone 50 Mg/5 Gram Pkt Gel In Packet

Females And Males Of Reproductive Potential

Infertility

Testis disorder, testicular atrophy, and oligospermia have been identified during use of Testosterone Gel 1% .

During treatment with large doses of exogenous androgens, including Testosterone Gel 1%, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis . Reduced fertility is ob served in some men taking testosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids . With either type of use, the impact on fertility may be irreversible.

How Supplied/storage And Handling

Testosterone Gel 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively.

NDC 64380-151-02 30 packets

NDC 64380-152-02 30 packets

Storage

Store at 25°C excursions permitted to 15° to 30°C .

Disposal

Used Testosterone Gel 1% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

What Should I Discuss With My Healthcare Provider Before Using Testosterone Topical

You should not use this medicine if you are allergic to testosterone patches or gels, or if you have

• prostate cancer or

Tell your doctor if you have ever had:

• breast cancer or prostate cancer
• enlarged prostate, urination problems
• a heart attack, stroke, or blood clot
• sleep apnea or
• liver or kidney disease.

The testosterone transdermal patch may burn your skin if you wear the patch during an MRI . Remove the patch before undergoing such a test.

Using testosterone may increase your risk of developing prostate cancer. Ask your doctor about this risk.

Testosterone can lower your sperm count and may affect fertility .

This medicine should not be used by a woman. Testosterone may harm an unborn baby. A pregnant woman should avoid coming into contact with testosterone topical patches or gels, or with a man’s skin areas where a patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away.

Do not use testosterone topical on anyone younger than 18 years old.

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What Is Testosterone Topical

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

Testosterone topical is used to treat conditions in men that result from a lack of natural testosterone.

Testosterone will not enhance athletic performance and should not be used for that purpose.

Testosterone topical may also be used for purposes not listed in this medication guide.

Carcinogenesis Mutagenesis Impairement Of Fertility

Carcinogenesis

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 rats, dogs and non-human primates, which was reversible on cessation of the treatment.

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Potential For Secondary Exposure To Testosterone And Steps To Prevent Secondary Exposure

Secondary exposure to testosterone in children and women can occur with the use of Testosterone Gel in men . Cases of secondary exposure to testosterone have been reported in children.

Physicians should advise patients of the reported signs and symptoms of secondary exposure which may include the following:

• In women changes in hair distribution, increase in acne, or other signs of testosterone effects
• The possibility of secondary exposure to Testosterone Gel should be brought to the attention of a healthcare provider
• Testosterone Gel 1% should be promptly discontinued until the cause of virilization is identified

Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone from Testosterone Gel in men :

Indications And Usage For Testosterone Gel

Testosterone Gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

• Primary hypogonadism : testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins above the normal range.
• Hypogonadotropic hypogonadism : gonadotropin or luteinizing hormone-releasing hormone deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.

Limitations of use:

• Safety and efficacy of Testosterone Gel 1% in men with “age-related hypogonadism” have not been established.
• Safety and efficacy of Testosterone Gel 1% in males less than 18 years old have not been established .
• Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure .

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Testosterone Gel Dosage And Administration

Dosage and Administration for Testosterone Gel 1% differs from Testosterone Gel 1.62 %. For dosage and administration of Testosterone Gel 1.62% refer to its full prescribing information.

Prior to initiating Testosterone Gel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Patient Assistance & Copay Programs For Testosterone

Patient assistance programs are usually sponsored by pharmaceutical companies and provide free ordiscounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines.Eligibility requirements vary for each program.

There are currently no Patient Assistance Programs that we know about for this drug.

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How To Use Testosterone Transdermal

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using testosterone gel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

There are many testosterone products available for use on the skin. They may have different amounts of testosterone and may not have the same effects. Read the dosing instructions carefully for each product. Do not change products without asking your doctor or pharmacist.

If you are using the gel pump, learn how to prepare the pump for use. You may pump this medication into the palm of your hand or directly onto the desired application site. If you are not sure how to use the pump, ask your pharmacist.

Apply the medication as directed to clean, dry skin of the shoulders/upper arms once daily in the morning or as directed by your doctor. Apply only to areas that would be covered if you were to wear a short sleeve t-shirt. Certain brands of this medication may also be applied to the stomach area . Check your product’s instructions or ask your pharmacist if your brand may be applied to the abdomen. Avoid applying this medication to broken, irritated skin. Do not apply to the genitals . Do not let others apply this medication to your body.

Dosage is based on your medical condition, laboratory tests, and response to treatment.

This medication is flammable until dry. Let the gel dry before smoking or going near an open flame.

Potential Adverse Reactions With Androgens

Patients should be informed that treatment with androgens may lead to adverse reactions which include:

• Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing 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 and weak urine flow.
• Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
• Nausea, vomiting, changes in skin color, or ankle swelling.

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Clinical Trials In Adult Hypogonadal Males

Testosterone Gel 1% was evaluated in a multi-center, randomized, parallel-group, active-controlled, 180-day trial in 227 hypogonadal men. The study was conducted in 2 phases. During the Initial Treatment Period , 73 patients were randomized to Testosterone Gel 1% 50 mg daily, 78 patients to Testosterone Gel 1% 100 mg daily, and 76 patients to a non-scrotal testosterone transdermal system. The study was double-blind for dose of Testosterone Gel 1% but open-label for active control. Patients who were originally randomized to Testosterone Gel 1% and who had single-sample serum testosterone concentrations above or below the normal range on Day 60 were titrated to 75 mg daily on Day 91. During the Extended Treatment Period , 51 patients continued on Testosterone Gel 1% 50 mg daily, 52 patients continued on Testosterone Gel 1% 100 mg daily, 41 patients continued on a non-scrotal testosterone transdermal system , and 40 patients received Testosterone Gel 1% 75 mg daily. Upon completion of the initial study, 163 enrolled and 162 patients received treatment in an open-label extension study of Testosterone Gel 1% for an additional period of up to 3 years.

Figure2: Mean Steady-State Testosterone Concentrations in Patients with Once-Daily Testosterone Gel 1% Therapy

Table 4: Mean Steady-State Serum Testosterone Concentrations During Therapy

Testosterone 50 Mg/5 Gram Pkt

• TESTOSTERONE 50 MG/5 GRAM PKT

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What Should I Avoid While Using Testosterone Topical

Avoid swimming, bathing, or showering for at least 2 hours after applying testosterone gel. Follow the directions provided with your specific brand.

Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.

Avoid using an ointment form of any steroid skin medicine your doctor recommends to treat skin irritation caused by wearing a testosterone skin patch. This includes over-the-counter hydrocortisone.

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Testosterone 1 % Transdermal Gel Packet

The photos shown are samples onlyNot all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.close popup

Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. If this occurs, the child may have unwanted side effects due to testosterone gel. Children should avoid contact with the unwashed or unclothed area where the medication has been applied. Tell both of your doctors right away if you notice unexpected signs of puberty in a child such as unusual increase in size of genitals , early development of pubic hair, increased erections or sex drive, or aggressive behavior. To decrease this risk, carefully follow all directions for the proper use of this drug.

This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone . This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels.

Testosterone helps the body to develop and maintain the male sexual characteristics , such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.

This drug should not be used by women.

Dosage is based on your medical condition, laboratory tests, and response to treatment.

Tell your doctor if your condition does not improve or if it worsens.

Abuse Of Testosterone And Monitoring Of Serum Testosterone Concentrations

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions .

If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

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See Full Prescribing Information For Complete Boxed Warning

What Is The Most Important Information I Should Know About Testosterone Topical

You should not use this medicine if you have prostate cancer or male breast cancer.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Testosterone can harm an unborn baby. A pregnant woman should avoid coming into contact with this medicine, or with a man’s skin where the medicine has been applied.

Misuse of testosterone can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.

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Warning: Secondary Exposure To Testosterone

• Virilization has been reported in children who were secondarily exposed to Testosterone Gel .
• Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Gel .
• Healthcare providers should advise patients to strictly adhere to recommended instructions for use .

What Happens If I Miss A Dose

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

If a skin patch falls off in the morning, reapply it. If it does not stick well, apply a new patch. If the patch falls off in the afternoon and cannot be reapplied, wait until your regular patch replacement time in the evening before putting on a new patch.

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Worsening Of Benign Prostatic Hyperplasia And Potential Risk Of Prostate Cancer

• Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
• Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens .

Patients Should Be Advised Of The Following Instructions For Use:

• Read the Medication Guide before starting testosterone gel 1% therapy and to reread it each time the prescription is renewed
• Testosterone gel 1% should be applied and used appropriately to maximize the benefits and to minimize the risk of secondary exposure in children and women
• Keep testosterone gel 1% out of the reach of children
• Testosterone gel 1% is an alcohol based product and is flammable therefore avoid fire, flame or smoking until the gel has dried
• It is important to adhere to all recommended monitoring
• Report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood
• Testosterone gel 1% is prescribed to meet the patients specific needs therefore, the patient should never share testosterone gel 1% with anyone.
• Wait 5 hours before swimming or washing following application of testosterone gel 1%. This will ensure that the greatest amount of testosterone gel 1% is absorbed into their system.

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What Are The Possible Side Effects Of Testosterone Topical

Get emergency medical help if you have signs of an allergic reaction: hives difficulty breathing swelling of your face, lips, tongue, or throat.

Stop using testosterone topical and call your doctor at once if you have:

• increased urination , loss of bladder control
• painful or difficult urination
• swelling, rapid weight gain, shortness of breath during sleep
• chest pain or pressure, pain spreading to your jaw or shoulder
• liver problems–nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice
• signs of a blood clot in the lung–chest pain, sudden cough, wheezing, rapid breathing, coughing up blood or
• signs of a blood clot deep in the body–swelling, warmth, or redness in an arm or leg.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Common side effects may include:

• redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn
• increased red blood cells
• increased prostate-specific antigen