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13.10.2013, admin  
Category: Testosterone Supplements For Men

Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-14 en-3-one. Topical administration of testosterone 5 g, 7.5 g, or 10 g contains 50 mg, 75 mg, or 100 mg of testosterone, respectively, is to be applied daily to the skin’s surface.
Inactive ingredients in testosterone are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. Testosterone gel: Testosterone gel is a clear, colorless hydroalcoholic gel containing testosterone.
Inactive ingredients in testosterone gel are carbomer 980, ethanol 67.0%, isostearic acid, purified water, and sodium hydroxide. To ensure proper dosing, serum testosterone concentrations should be measured at intervals.
The application site and dose of testosterone gel 1% are not interchangeable with other topical testosterone products.
The patient should be advised to avoid swimming or showering for at least 5 hours after the application of testosterone gel 1%.
The entire contents should be squeezed into the palm of the hand and immediately applied to the application sites.
The dose can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations). The application site and dose of testosterone gel (ANDROGEL) 1.62% are not interchangeable with other topical testosterone products.
Testosterone gel (ANDROGEL) 1.62% should be applied to clean, dry, intact skin of the upper arms and shoulders. The prescribed daily dose of testosterone gel (ANDROGEL) 1.62% should be applied to the right and left upper arms and shoulders as shown in the shaded areas in Figure 1. The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application.
The recommended starting dose of testosterone gel is 40 mg of testosterone (4 pump actuations) applied once daily to the thighs in the morning. The application site and dose of FORTESTA are not interchangeable with other topical testosterone products. Testosterone gel should be applied directly to clean, dry, intact skin of the front and inner thighs. In order to prevent transfer to another person, clothing should be worn to cover the application sites. In order to maintain serum testosterone levels in the normal range, the sites of application should not be washed for at least two hours after application of testosterone. Secondary exposure to testosterone in children and women can occur with testosterone gel use in men. Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone.
Due to lack of controlled evaluations in women and potential virilizing effects, testosterone gel is not indicated for use in women [see Use in Specific Populations]. At large doses of exogenous androgens, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count. Gynecomastia may develop and may persist in patients being treated with androgens, including testosterone gel, for hypogonadism. The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases [see Adverse Reactions]. Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Androgens, including testosterone gel, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Androgens, including testosterone gel, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4.
Alcohol based products, including testosterone gel, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the testosterone gel has dried. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 8 shows the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with testosterone gel and reported by >1% of patients in a 180 Day, Phase 3 study.
Other less common adverse reactions, reported in fewer than 1% of patients included: amnesia, anxiety, discolored hair, dizziness, dry skin, hirsutism, hostility, impaired urination, paresthesia, penis disorder, peripheral edema, sweating, and vasodilation.
In this 180 day clinical trial, skin reactions at the site of application were reported with testosterone gel, but none was severe enough to require treatment or discontinuation of drug. Six patients (4%) in this trial had adverse events that led to discontinuation of testosterone gel. In a separate uncontrolled pharmacokinetic study of 10 patients, two had adverse events associated with testosterone gel 1%; these were asthenia and depression in one patient and increased libido and hyperkinesia in the other.
In a 3 year, flexible dose, extension study, the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with testosterone gel 1% and reported by > 1% of patients is shown in Table 9. Two patients reported serious adverse events considered possibly related to treatment: deep vein thrombosis (DVT) and prostate disorder requiring a transurethral resection of the prostate (TURP). Discontinuation for adverse events in this study included: two patients with application site reactions, one with kidney failure, and five with prostate disorders (including increase in serum PSA in 4 patients, and increase in PSA with prostate enlargement in a fifth patient). The following adverse reactions have been identified during post approval use of testosterone gel 1%. Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance.
Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
The concurrent use of testosterone with ACTH or corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease. Testosterone gel 1% is contraindicated during pregnancy or in women who may become pregnant. Although it is not known how much testosterone transfers into human milk, testosterone gel 1% is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. The safety and efficacy of testosterone gel 1% in pediatric patients less than 18 years old has not been established.
There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel 1% to determine whether efficacy in those over 65 years of age differs from younger subjects. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH. Testosterone is a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.
Oral ingestion of testosterone gel will not result in clinically significant serum testosterone concentrations due to extensive first-pass metabolism. Although drug dependence is not documented in individuals using therapeutic doses of anabolic steroids for approved indications, dependence is observed in some individuals abusing high doses of anabolic steroids.


Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.
Testosterone gel is a hydroalcoholic formulation that dries quickly when applied to the skin surface. When testosterone gel treatment is discontinued after achieving steady state, serum testosterone levels remain in the normal range for 24 to 48 hours but return to their pretreatment levels by the fifth day after the last application. Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin. There is considerable variation in the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes.
DHT concentrations increased in parallel with testosterone concentrations during testosterone gel treatment. About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6% of a dose is excreted in the feces, mostly in the unconjugated form. AndroGel 1% is supplied in non-aerosol, metered-dose pumps that deliver 12.5 mg of testosterone per complete pump actuation. FORTESTA is supplied in 60 g canisters with a metered dose pump that delivers10 mg of testosterone per complete pump actuation.
FORTESTA is available in packages of 1, 2 and 3 canisters (NDC 63481-183-16, NDC 63481-183-17 and NDC 63481-183-18, respectively). Used AndroGel pumps or used AndroGel packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets. Used FORTESTA canisters should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets. Testosterone gel (by Perrigo Israel) is supplied in non-aerosol, metered-dose pumps that deliver 12.5 mg of testosterone per complete pump actuation. Vogelxo is supplied in unit-dose tubes in cartons of 30 and unit-dose packets in cartons of 30.
Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days.
Inj site reactions, peliosis hepatis, premature epiphyseal closure in adolescents, edema, hepatic carcinoma, prostatic hypertrophy or carcinoma, gynecomastia, priapism, oligospermia, nausea, jaundice, hirsutism, virilization, male pattern baldness, acne, polycythemia, headache, anxiety, depression, paresthesias, altered libido, fluid and electrolyte disturbances, suppression of clotting factors, increased serum cholesterol.
These statements have not been evaluated by the Food and Drug Administration, and individual results may vary. This product should be taken as part of a healthy lifestyle and is not intended to diagnose, treat, cure or prevent any disease. Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period. Each pump actuation provides 10 mg of testosterone and each container is capable of dispensing 120 pump actuations. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. If the serum testosterone concentration is below the normal range, the daily testosterone gel 1% dose may be increased from 50 mg to 75 mg and from 75 mg to 100 mg for adult males as instructed by the physician (see Table 1, Dosing Information for Testosterone gel 1%). Area of application should be limited to the area that will be covered by the patient’s short sleeve T-shirt.
To do so, with the canister in the upright position, slowly and fully depress the actuator three times. Alternately, patients may squeeze a portion of the gel from the packet into the palm of the hand and apply to application sites. To ensure proper dosing, the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment. Do not apply testosterone gel 1.62% to any other parts of the body, including the abdomen or genitals.
Avoid fire, flames or smoking until the gel has dried since alcohol based products, including testosterone gel 1.62%, are flammable. Testosterone gel 1.62% should be delivered directly into the palm of the hand and then applied to the application sites. The area of application should be limited to the area that will be covered by a short sleeve t-shirt. The dose can be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone. To do so, with the canister in the upright position, slowly and fully depress the actuator eight times. Morning serum testosterone levels should then be measured approximately 14 days after initiation of therapy to ensure proper serum testosterone levels are achieved. If direct skin-to-skin contact with another person is anticipated, the application sites must be washed thoroughly with soap and water.
Evaluation of the patient for prostate cancer prior to initiating and during treatment with androgens is appropriate [see Warnings and Precaution, and Adverse Reactions]. Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Testosterone gel should be promptly discontinued until the cause of virilization has been identified. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions].
Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. These events included: cerebral hemorrhage, convulsion (neither of which were considered related to testosterone gel administration), depression, sadness, memory loss, elevated prostate specific antigen, and hypertension.
Serum PSA was measured every 6 months thereafter in the 162 hypogonadal men on testosterone gel 1% in the 3-year extension study.
Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 10).
Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
More frequent monitoring of INR and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
Testosterone and other androgens may adversely affect lactation [see Contraindications (4)]. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer.
The skin serves as a reservoir for the sustained release of testosterone into the systemic circulation.
Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins. After 180 days of treatment in adult males, mean DHT concentrations were within the normal range with 5 g testosterone gel and were about 7% above the normal range after a 10 g dose.


In addition, any discarded gel should be thoroughly rinsed down the sink or discarded in the household trash in a manner that prevents accidental application or ingestion by children or pets. Monitor liver function, hemoglobin, hematocrit, prostate specific antigen (PSA), cholesterol, bone age. If the serum testosterone concentration exceeds the normal range, the daily testosterone gel 1% dose may be decreased. Do not apply testosterone gel 1% to any other part of the body including the genitals, chest or back. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including testosterone gel 1%, are flammable. Area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt. To ensure proper dosing, the dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying testosterone gel and at approximately 14 days and 35 days after starting treatment or following dose adjustment. Patients should be instructed to use one finger to gently rub testosterone gel evenly onto the front and inner area of each thigh as directed in Table 5.
If the serum testosterone concentration is below the normal range, or if the desired clinical response is not achieved, the daily testosterone dose may be increased from 5 g (one tube) to 10 g (two tubes) as instructed by the physician.
Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. There was no additional statistically significant increase observed in mean PSA from 6 months through 36 months. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure.
It would be most unlikely that such plasma testosterone concentrations be achieved using the transdermal route.
Testosterone and DHT are necessary for the normal development of secondary sex characteristics. Approximately 10% of the testosterone dose applied on the skin surface from testosterone gel is absorbed into systemic circulation. It is also used to treat certain types of breast cancer in women.Testosterone Enanthate is a male sex hormone.
If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 50 mg, testosterone gel 1% therapy should be discontinued. Patients should be instructed to use the palm of the hand to apply testosterone gel 1.62% and spread across the maximum surface area as directed in Table 3 and in Figure 1. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including testosterone gel, are flammable. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. However, there were increases in serum PSA observed in approximately 18% of individual patients. In a few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greater than chronological age. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Therefore, 5 g and 10 g of testosterone gel systemically deliver approximately 5 mg and 10 mg of testosterone, respectively. It works by replacing or supplementing the testosterone that is naturally made in the body. After the priming procedure, patients should completely depress the pump one time actuation for every 12.5 mg of testosterone required to achieve the daily prescribed dosage.
Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with testosterone [see Warnings and Precautions and Use in Specific Populations]. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age.
In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. Symptoms associated with male hypogonadism include impotence and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis. In a study with 10 g of testosterone gel, all patients showed an increase in serum testosterone within 30 minutes, and eight of nine patients had a serum testosterone concentration within normal range by 4 hours after the initial application. The product should be delivered directly into the palm of the hand and then applied to the desired application sites.
The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of testosterone gel. Absorption of testosterone into the blood continues for the entire 24-hour dosing interval. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:if you are pregnant, planning to become pregnant, or are breast-feedingif you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplementif you have allergies to medicines, foods, or other substances (especially sesame oil)if you have heart disease, heart failure, coronary artery disease, angina (chest pain), high cholesterol levels, swelling (edema), lung disease, or sleep apnea (long pauses in breathing while you sleep)if you have diabetes, an enlarged prostate, kidney or liver disease, high blood calcium levels, or obesitySome MEDICINES MAY INTERACT with Testosterone Enanthate .
Serum concentrations approximate the steady-state level by the end of the first 24 hours and are at steady state by the second or third day of dosing. Tell your health care provider if you are taking any other medicines, especially any of the following:Carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because their actions and the risk of their side effects may be increased by Testosterone Enanthate Anticoagulants (eg, warfarin), insulin, or oral hypoglycemics (eg, glyburide) because their side effects, including risk of bleeding, may be increased by Testosterone Enanthate Propranolol because its effectiveness may be decreased by Testosterone Enanthate This may not be a complete list of all interactions that may occur.
Ask your health care provider if Testosterone Enanthate may interact with other medicines that you take. Check the label on the medicine for exact dosing instructions.Testosterone Enanthate is usually given as an injection at your doctor's office, hospital, or clinic.
If you will be using Testosterone Enanthate at home, a health care provider will teach you how to use it.
Follow all local rules for disposal.If you miss a dose of Testosterone Enanthate , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Ask your doctor before you change the dose of your diabetes medicine.Testosterone Enanthate may interfere with certain lab tests.
Be sure your doctor and lab personnel know you are using Testosterone Enanthate .Lab tests, including liver function, blood cell counts, blood cholesterol, prostatic specific antigen, bone growth, and blood testosterone, may be performed while you use Testosterone Enanthate .



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