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27.02.2016, admin  
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Testosterone cream is one of many topical testosterone products to help increase testosterone levels. AndroGelA® (testosterone gel) 1.62% is a prescription medicine used to treat adult males who have low or no testosterone. Testosterone Enanthate Injection, USP provides testosterone enanthate, a derivative of the primary endogenous androgen testosterone, for intramuscular administration. Testosterone enanthate is designated chemically as androst-4-en-3-one, 17-[(1-oxoheptyl)-oxy]-, (17?)-. Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Androgens also cause retention of nitrogen, sodium, potassium, and phosphorus, and decreased urinary excretion of calcium. Androgens are responsible for the growth spurt of adolescence and for the eventual termination of linear growth which is brought about by fusion of the epiphyseal growth centers.
During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.
Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about two percent is free.
About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about six percent of a dose is excreted in the feces, mostly in the unconjugated form. In responsive tissues, the activity of testosterone appears to depend on reduction to dihydrotestosterone (DHT), which binds to cytosol receptor proteins. Testosterone Enanthate Injection, USP is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired) - Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) - Idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Delayed puberty - Testosterone Enanthate Injection, USP may be used to stimulate puberty in carefully selected males with clearly delayed puberty. Metastatic mammary cancer - Testosterone Enanthate Injection, USP may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate and in women who are or may become pregnant. This preparation is also contraindicated in patients with a history of hypersensitivity to any of its components.
In patients with breast cancer and in immobilized patients, androgen therapy may cause hypercalcemia by stimulating osteolysis. Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see PRECAUTIONS, Carcinogenesis).
If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma. Due to sodium and water retention, edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.
Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly, and menstrual irregularities).
Because androgens may alter serum cholesterol concentration, caution should be used when administering these drugs to patients with a history of myocardial infarction or coronary artery disease. Male adolescent patients receiving androgens for delayed puberty should have bone development checked every six months. Clinical studies of Testosterone Enanthate Injection, USP did not include sufficient numbers of subjects, aged 65 and older, to determine whether they respond differently from younger subjects. When properly given, injections of Testosterone Enanthate Injection, USP are well tolerated. Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgen therapy (see WARNINGS). Periodic (every six months) X-ray examinations of bone age should be made during treatment of pre-pubertal males to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers. Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of androgens.
Anticoagulants, oral - C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirement. Antidiabetic drugs and insulin - In diabetic patients, the metabolic effects of androgens may decrease blood glucose and insulin requirements.


Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses.
Androgen therapy should be used very cautiously in pediatric patients and only by specialists who are aware of the adverse effects on bone maturation.
Endocrine and Urogenital, Female - The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement. Fluid and Electrolyte Disturbances - Retention of sodium, chloride, water, potassium, calcium (see WARNINGS), and inorganic phosphates.
Gastrointestinal - Nausea, cholestatic jaundice, alterations in liver function tests; rarely, hepatocellular neoplasms, peliosis hepatis (see WARNINGS). Nervous System - Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Testosterone Enanthate Injection, USP is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III. Dosage and duration of therapy with Testosterone Enanthate Injection, USP will depend on age, sex, diagnosis, patient's response to treatment, and appearance of adverse effects. In general, total doses above 400 mg per month are not required because of the prolonged action of the preparation.
Various dosage regimens have been used; some call for lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels.
Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. These drugs are commonly prescribed to men with no or low testosterone to alleviate symptoms of fatigue, depression, decreased muscle mass and low libido. FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. Hair Loss is a common problem that almost everybody faces at least once in his or her life. Read up on testosterone replacement therapies, both prescription and non-prescription in this article. Safe, yet extremely potent, testosterone gel is absorbed through the skin directly into the blood stream.
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Androgens have been reported to increase protein anabolism and decrease protein catabolism. In children, exogenous androgens accelerate linear growth rates but may cause a disproportionate advancement in bone maturation. At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).
Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus testosterone enanthate can be given at intervals of two to four weeks. Generally, the amount of this sex-hormone binding globulin (SHBG) in the plasma will determine the distribution of testosterone between free and bound forms, and the free testosterone concentration will determine its half-life. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.
Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date.
When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Serial determinations of serum cholesterol should be made and therapy adjusted accordingly.
Testosterone replacement is not indicated in geriatric patients who have age-related hypogonadism only ("andropause"), because there is insufficient safety and efficacy information to support such use.
Care should be taken to slowly inject the preparation deeply into the gluteal muscle, being sure to follow the usual precautions for intramuscular administration, such as the avoidance of intravascular injection. Patients receiving oral anticoagulant therapy require close monitoring especially when androgens are started or stopped. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from androgens, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Skeletal maturation must be monitored every six months by an X-ray of the hand and wrist (see INDICATIONS AND USAGE, and WARNINGS).


Other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. Women with metastatic breast carcinoma must be followed closely because androgen therapy occasionally appears to accelerate the disease. Warming and rotating the vial between the palms of the hands will redissolve any crystals that may have formed during storage at low temperatures. Esterification of the 17-beta-hydroxy group increases the duration of action of testosterone; hydrolysis to free testosterone occurs in vivo. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. This virilization includes clitoromegaly, abnormal vaginal development and fusion of genital folds to form a scrotal-like structure. If hypercalcemia occurs, the drug should be discontinued and appropriate measures instituted.
In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth.
Such virilization is usual following androgen use at high doses and is not prevented by concomitant use of estrogens.
A causal relationship between myocardial infarction and hypercholesterolemia has not been established. Current studies do not assess whether testosterone use increases risks of prostate cancer, prostate hyperplasia, and cardiovascular disease in the geriatric population. There have been rare postmarketing reports of transient reactions involving urge to cough, coughing fits, and respiratory distress immediately after the injection of Testosterone Enanthate Injection, USP, an oil-based depot preparation (see DOSAGE AND ADMINISTRATION).
There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma.
When administered to a pregnant woman, androgens cause virilization of the external genitalia of the female fetus. Care should be taken to slowly inject the preparation deeply into the gluteal muscle, being sure to follow the usual precautions for intramuscular administration, such as the avoidance of intravascular injection (see PRECAUTIONS). The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.
Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. Each mL of sterile, colorless to pale yellow solution provides 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol (chloral derivative) as a preservative.
Androgens have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietic stimulating factor. There are considerable variations of the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration.
This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. The degree of masculinization is related to the amount of drug given and the age of the fetus and is most likely to occur in the female fetus when the drugs are given in the first trimester. A decision may be made by the patient and the physician that some virilization will be tolerated during treatment for breast carcinoma.
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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Dosage is within the range of 50 to 200 mg every 2 to 4 weeks for a limited duration, for example, 4 to 6 months.
An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers (see WARNINGS). Judgment concerning androgen therapy should be made by an oncologist with expertise in this field. If the patient becomes pregnant while taking androgens, she should be apprised of the potential hazard to the fetus.
X-rays should be taken at appropriate intervals to determine the amount of bone maturation and skeletal development (see INDICATIONS AND USAGE, and WARNINGS). Both bioidentical and non-bioidentical testosterone drugs are synthesized in this manner.



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