Testosterone Enanthate 250®

Testosterone Enanthate is used in replacement therapy in conditions associated with deficiency of endogenous testosterone. It is an oil based injectable, designed to release testosterone slowly from the injection site. Once administered, serum concentrations of this hormone will rise for several days, and remain markedly elevated for approximately two weeks.

For medical purposes this is the most widely prescribed testosterone used regularly to treat cases of hypogonadism and other disorders related to androgen deficiency. As with all testosterone products it has a strong anabolic activity, with a pronounced androgenic component. Significant gains in strength and muscle tissue as well a noticeable increase in libido.

  • Product Description

    Testosterone Enanthate 250 Injection provides testosterone enanthate, a derivative of the primary endogenous androgen testosterone.

    Chemical:Testosterone Enanathate 250mg/ml

    Molecular Formula: C26H40O3

    Molecular Weight: 400.59.

    Percent Composition: C 77.95%, H 10.06%, O 11.98%

    Melting point: mp 36-37.5°

    Prescription Medicine

  • Indications

    Males

    Testosterone Enanthate Injection is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.

    Primary hypogonadism : Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.

    Hypogonadotropic hypogonadism : Idiopathic gonadotropin or luteinizing hormone – releasing hormone (LHRH) deficiency, or pituitary – hypothalamic injury from tumors, trauma, or radiation.

    Delayed Puberty : Testosterone Enanthate Injection may be used to stimulate puberty in carefully selected males with clearly delayed puberty.

    Females

    Metastatic mammary cancer: Testosterone Enanthate Injection may be used secondarily in women with advancing inoperable metastatic mammary cancer who are one to five years postmenopausal. It has also been used in premenopausal women who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.

  • Precautions

    General: Women should be observed for signs of virilization.

    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.

    All patients : Any nausea, vomiting, changes in skin color or ankle swelling.
    PATIENT MONITORING

    Bone age determinations
    Cholesterol and/or HDL and LDL
    Hemoglobin and Hematocrit determinations
    Hepatic function determinations
    Prostatic acid phosphatase and prostatic specific antigen
    Testosterone, total, serum

    For treatment of breast carcinoma

    Alkaline phosphatase, serum values and physical examination and x-rays of known or suspected metastases
    Calcium

    For gender change androgen therapy

    LH (Luteinizing hormone)
    ALT [SGPT] (Alkaline aminotransferase)

    For pediatrics

    Androgens should be used with caution in children and adolescents who are still growing because of possible premature epiphyseal closure in males and females, precocious sexual development in prepubertal males, or virilization in females. Skeletal maturation should be monitored at 6-month intervals by an x-ray of the hand and wrist.

    For geriatrics

    Treatment of male patients over the age of approximately 50 years with androgens should be preceded by a thorough examination of the prostate and baseline measurement of prostatespecific antigen serum concentration since androgens may cause increased risk of prostatic hypertrophy or may stimulate the growth of occult prostatic carcinoma. Periodic evaluation of prostate function should also be performed during the course of therapy.

  • Dosage and Administration

    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 (see INDICATIONS AND USAGE AND WARNINGS).

    Palliation of inoperable mammary cancer in woman: 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 occassionally appears to accelerate the disease.