The chemical name for Testosterone Enanthate, USP is designated chemically as androst-4-en-3-one, 17-[(1-oxoheptyl)-oxy]-, (17β)-.
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Testosterone Enanthate - Clinical Pharmacology
Testosterone - Endogenous Androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement; vocal chord thickening; alterations in body musculature; and fat distribution.
Androgens like Enanthate Testosterone also cause retention of nitrogen, sodium, potassium, and phosphorus, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.
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. In children, exogenous androgens accelerate linear growth rates but may cause a disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietic stimulating factor.
During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens including testosterone injections, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).
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Testosterone Enanthate Pharmacokinetics
Enanthate Injectable Testosterone is a Long Acting esterized Steroid Drug
Testosterone Enanthate is a Long-activating testosterone drug formulation.. Testosterone esters are less polar than free testosterone in the bloodstream. 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.
Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about two percent is free. 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.
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. Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways. There are considerable variations of the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes.
In responsive tissues, the activity of testosterone appears to depend on reduction to dihydrotestosterone (DHT), which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.
Indications and Usage for Testosterone Enanthate
Males and TRT using Injectable Enanthate Testosterone
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. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)
If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
Delayed puberty – Testosterone Enanthate Injection, USP may be used to stimulate puberty in carefully selected males with clearly delayed 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. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. 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.
Females and TRT - Testosterone fro Women
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. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. 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. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.
Why use Enanthate Injections for Male Hormone Replacement?
Testosterone enanthate is an ester of the naturally occurring androgen, testosterone.
In the body, the ester is cleaved by the esterase completely released and the steroid occurring naturally. Since both testosterone enanthate has a very strong androgenic and anabolic effect, it is used by many users who want to build a lot of strength and mass in the shortest time. The optimal injection interval should be specified with 5-6 days.
What is Testosterone Enanthate?
Testosterone enanthate is an ester of the male hormone testosterone.
Testosterone is responsible for male sex characteristics.
Testosterone Enanthate is a widely used androgenic anabolic steroid hormone used for male HRT and considered by many hormone specialists and anti-aging medical doctors as
one of the best choice for injectable testosterones for TRT.
Testosterone is used by men and women for hormone replacment therapy and should not be used as anabolic steroids for bodybuilding or sports athletics enhancement purposes.
Before and After Effects of Testosterone Enanthate
Enanthate Testosterone before and after effects are better mood, stronger bones, increased energy, sex drive, drive, ambition and lean muscle mass.
Improved body composition and bigger muscles escpecially when taken with Human Growth Hormone, even though HGH is not an anabolic steroid.
Estrogen inhibitors and HCG are used to combat excess testosterone which aromatizes to estrogen.
Patients prescribed Enanthate Testosterone will also be prescribed anti-estrogens such as Nolvadex Tamoxifen, Clomid Chlomephine or Anastrazole Arimidex
which helps prevent estrogen from binding to a man's estrogen receptors to avoid estrogenic side effects.
How Testosterone Enanthate Injections Work
Testosterone enanthate is an oil based injectable steroid which forms a hormone depot under the skin to slowly release testosterone from the injection site.
Once the enanthate androgen steroid drug is administered, serum concentrations of the hormone peaks and for several days remains at realtively high levels with a half life of 3 to 4 days on avergae.
While free testosterone levels will stay elevated for approximately five days, it can take up to two full weeks for the active life of this androgen drug to fully diminish.
For Hormone Replacment Therapy purposes, Enanthate is the most widely prescribed testosterone after the Cypionate form of androgen injectable.
Enanthate is prescribed regularly to treat primary and secondary hypogonadism (Low T), Erectile Dysfunction and other male endocrine disorders related to androgen hormone deficiency.
TRT Patients usually self-administer enanthate injections, along with HCG or Human Chorionic Gonaditropin to ensure excess testosterone is properly managed from the aromatase conversion to estrogen.
Enanthate Androgen Therapy is many times used in conjunction with other testosterons such as cypionate and propionate in a multi-blend injectable testosterone solution to treat Low T Symptoms in Men.
While enathat requires a less frequent dosage schedule than propionate, it requires a more frequent administration schedula than undecanoate or cypionates such as Depo-Testosterone due to
its shorter half life.
Does Testosterone Enanthate have Side effects?
Like other esterized testosterones and anabolic steroid compounds, Enanthate can have side effects. Testosterone is a powerful hormone with notably prominent side effects. Much of which stem from the fact that testosterone exhibits a high tendency to convert into estrogen. Related side effects may therefore become a problem during a cycle. For starters, water retention can become quite noticeable. This can produce a clear loss of muscle definition, as subcutaneous fluids begin to build. The storage of excess body fat may further reduce the visibility of muscle features, another common problem with aromatizing steroids. The excess estrogen level during/after your cycle also has the potential to lead up to gynecomastia. Adding an ancillary drug like Nolvadex and/or Proviron is therefore advisable to those with a known sensitivity to this side effect. The anti-aromatase Arimidex, Femara, or Aromasin are a much better choices though. It is believed that the use of an anti-estrogen can slightly lower the anabolic effect of most androgen cycles (estrogen and water weight are often thought to facilitate strength and muscle gain), so one might want to see if such drugs are actually necessary before committing to use. A little puffiness under the nipple is a sign that gynecomastia is developing. If this is left to further develop into pronounced swelling, soreness and the growth of small lumps under the nipples, some form of action should be taken immediately to treat it (obviously quitting the drug or adding ancillaries like Nolvadex).
Being a testosterone product, all the standard androgenic side effects are also to be expected. Oily skin, acne, aggressiveness, facial/body hair growth and male pattern baldness are all possible. Older or more sensitive individuals might therefore choose to avoid testosterone products, and look toward milder anabolics like DecaDurabolin or Equipoise which produce fewer side effects. Others may opt to add the drug Proscar/Propecia, which will minimize the conversion of testosterone into DHT (dihydrotestosterone). With blood levels of this metabolite notably reduced, the impact of related side effects should also be reduced. With strong bulking drugs however, the user will generally expect to incur strong side effects and will often just tolerate them. Most athletes really do not find the testosterones all that uncomfortable (especially in the face of the end result), as can be seen with the great popularity of such compounds.
Although this particular ester is active for a much longer duration, most prefer to inject it on a weekly or bi-weekly basis in order to keep blood levels stable. The usual dosage would be in the range of 250mg-750mg a week. This level is quite sufficient, and should provide the user a rapid gain of strength and body weight. Above this level estrogenic side effects will no doubt become much more pronounced, possibly outweighing any new muscle gained. Those looking for greater bulk would be better served by adding an oral like Anadrol or Dianabol, combinations which prove to work great. If one wishes to use a testosterone yet retain a level of quality and definition to the physique, an injectable anabolic like DecaDurabolin or Equipoise may prove to be a better choice. Here we can use a lower dosage of enanthate, so as to gain an acceptable amount of muscle but keep the buildup of estrogen to a minimum.
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With the proper administration of ancillary drugs, Nolvadex, Clomid, Arimidex and HCG, during post cycle recovery (PCT), much of the new muscle mass can be retained for a long time after the cycle has been stopped.
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Androgens including Enanthate 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. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. 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. If the patient becomes pregnant while taking androgens, she should be apprised of the potential hazard to the fetus.
This preparation is also contraindicated in patients with a history of hypersensitivity to any of its components.
Testosterone Enanthate Warnings
In patients with breast cancer and in immobilized patients, androgen therapy may cause hypercalcemia by stimulating osteolysis. In patients with cancer, hypercalcemia may indicate progression of bony metastasis. If hypercalcemia occurs, the drug should be discontinued and appropriate measures instituted.
Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma. Peliosis hepatis can be a life-threatening or fatal complication.
If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined. Drug-induced jaundice is reversible when the medication is discontinued.
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. In addition to discontinuation of the drug, diuretic therapy may be required. If the administration of Testosterone Enanthate is restarted, a lower dose should be used.
Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.
Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.
Testosterone Enanthate Drug Precautions
General Precautions of Using Enanthate Testosterone
Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly, and menstrual irregularities). Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Such virilization is usual following androgen use at high doses and is not prevented by concomitant use of estrogens. A decision may be made by the patient and the physician that some virilization will be tolerated during treatment for breast carcinoma.
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. Serial determinations of serum cholesterol should be made and therapy adjusted accordingly. A causal relationship between myocardial infarction and hypercholesterolemia has not been established.
Information for Patients using Testosterone
Male adolescent patients receiving androgens for delayed puberty should have bone development checked every six months.
The physician should instruct patients to report any of the following side effects of androgens:
Adult or adolescent males – too frequent or persistent erections of the penis.
Women – hoarseness, acne, changes in menstrual periods, or more facial hair.
All patients – any nausea, vomiting, changes in skin color, or ankle swelling.
Clinical studies of Testosterone Enanthate did not include sufficient numbers of subjects, aged 65 and older, to determine whether they respond differently from younger subjects. 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. Current studies do not assess whether testosterone use increases risks of prostate cancer, prostate hyperplasia, and cardiovascular disease in the geriatric population.
Intramuscular Administration of Testosterone Enanthate
When properly given, injections of Testosterone Enanthate are well tolerated. 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. There have been rare post-marketing reports of transient reactions involving urge to cough, coughing fits, and respiratory distress immediately after the injection of Testosterone Enanthate, an oil-based depot preparation.
Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgen therapy.
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.
Testosterone Drug Interactions
When administered concurrently, the following drugs may interact with Enanthate androgens:
Anticoagulants, oral – C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirement. Patients receiving oral anticoagulant therapy require close monitoring especially when androgens are started or stopped.
Antidiabetic drugs and insulin – In diabetic patients, the metabolic effects of androgens may decrease blood glucose and insulin requirements.
ACTH and corticosteroids – Enhanced tendency toward edema. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease.
Oxyphenbutazone – Elevated serum levels of oxyphenbutazone may result.
Drug Laboratory Test Interferences of Enanthate
Enanthate Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, 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.
There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
Pregnancy: Teratogenic Effects of Testosterone Therapy
It is not known whether androgens are excreted in human milk. 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.
Adverse Reactions of Testosterone Injections
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. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens cause virilization of the external genitalia of the female fetus.
Male – Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.
Skin and Appendages – Hirsutism, male pattern baldness, and acne.
Fluid and Electrolyte Disturbances – Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Gastrointestinal – Nausea, cholestatic jaundice, alterations in liver function tests; rarely, hepatocellular neoplasms, peliosis hepatis .
Hematologic – Suppression of clotting factors II, V, VII, and X; bleeding in patients on concomitant anticoagulant therapy; polycythemia.
Nervous System – Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Metabolic – Increased serum cholesterol.
Miscellaneous – Rarely, anaphylactoid reactions; inflammation and pain at injection site.
Drug Abuse and Dependence on Testosterone
Testosterone Enanthate is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III.
There have been no reports of acute overdosage with Enanthate androgens.
Testosterone Enanthate Dosage and Administration
Dosage and duration of therapy with Testosterone Enanthate injection will depend on age, sex, diagnosis, patient’s response to treatment, and appearance of adverse effects. When properly given, injections of Testosterone Enanthate, are well tolerated. 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.
In general, total doses above 400 mg per month are not required because of the prolonged action of the preparation. Injections more frequently than every two weeks are rarely indicated. NOTE: Use of a wet needle or wet syringe may cause the solution to become cloudy; however this does not affect the potency of the material. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Testosterone Enanthate injection is a clear, colorless to pale yellow solution.
Male hypogonadism: As replacement testosterone therapy, i.e., Andropause, impotence therapy or for eunuchism, the suggested dosage is 50 to 400 mg every week.
In males with delayed puberty: 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. Other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. 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. X-rays should be taken at appropriate intervals to determine the amount of bone maturation and skeletal development.
ENANTHATE TESTOSTERONE INDICATIONS AND USAGE & WARNINGS
Palliation of inoperable mammary cancer in women: A dosage of 200 to 400 mg every 2 to 4 weeks is recommended. Women with metastatic breast carcinoma must be followed closely because androgen therapy occasionally appears to accelerate the disease.
How is Testosterone Enanthate Supplied
Testosterone Enanthate Injection, USP 200 mg/mL is available as:
5 mL Multiple Dose vial, Cartons of 1 vial NDC 0143-9750-01
TESTOSTERONE ENANTHATE STORAGE
Testosterone Enanthate Injection should be stored at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
Warming and rotating the vial between the palms of the hands will redissolve any crystals that may have formed during storage at low temperatures.
Testosterone Enanthate injection, solution
|Testosterone Product Information
||HUMAN PRESCRIPTION DRUG LABEL
||Item Code (Source)
|Route of Administration
|Active Ingredient/Active Moiety
||Basis of Strength
|Testosterone Enanthate (TESTOSTERONE)
||200 mg in 1 mL
||5 mg in 1 mL
||5 mL in 1 VIAL, MULTI-DOSE
||Application Number or Monograph Citation
||Marketing Start Date
||Marketing End Date
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