Testosterone Propionate 100®

Testosterone Propionate is a short acting oil-based injectable formulation of testosterone. Testosterone inhibits gonadotropin secretion from the pituitary gland and ablates estrogen production in the ovaries, thereby decreasing endogenous estrogen levels. In addition, this agent promotes the maintenance of male sex characteristics and is indicated for testosterone replacement in hypogonadal males. (NCI04)

  • Product Description

    Chemical: Testosterone Propionate 100mg/ml

    Molecular Formula: C26H40O3

    Molecular Weight:344.495 g/mol

    Melting point:120 °C

    Prescription Medicine

  • Indications

    Males: Androgen Replacement Therapy:

    Test Prop is indicated for androgen replacement therapy in conditions associated with deficiency or absence of endogenous testosterone.

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

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

    Delayed puberty: Test Prop Injection may be used to stimulate puberty in carefully selected males with clearly delayed puberty that is not secondary to other pathological disorders.

    Females: Metastatic mammary cancer: Test Prop Injection may be used secondarily in women with advancing inoperable metastatic mammary cancer who are one to five years post-menopausal. It has also been used in pre-menopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone­-responsive tumor.

    Postpartum Breast Engorgement: as recommended by qualified physician.

  • Precautions

    Any nausea, vomiting, changes in skin color or ankle swelling should be monitored by a qualified physician, particularly in patients with a history of severe heart, liver, and kidney disease.

    Androgen therapy patients receiving concurrent warfarin treatment may present with unexpected increases in the INR and/or pro-thrombin time (PT). When administered to these patients, the dosing of warfarin may need to be reduced significantly to maintain the desired INR level and reduce the risk of serious bleeding.

    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.

    Androgens may reduce clotting factors II, V, VII, and X, and may increase pro-thrombin time (PT). Patients should be instructed to report any use of warfarin and any irregular bleeding.

    For Women: Women on androgen therapy should be observed for signs of virilization which may include the deepening of the voice, hirsutism, or clitoromegaly. Therapy should be discontinued upon signs of virilism to reduce the risk of irreversible virilization. Some virilizing effects may be irreversible after cessation of therapy even with concurrent administration of estrogens. Menstrual irregularities may also occur.

    For Children:

    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 pre-pubertal males, or virilization in females. Skeletal maturation should be monitored at 6-month intervals by 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 serum prostate-specific antigen (PSA) concentration, since androgens may cause increased risk of prostate hypertrophy or may stimulate the growth of occult prostatic carcinoma. Periodic evaluation of prostate functions should also be performed during the course of therapy.

  • Dosage and Administration

    Male Androgen Replacement Therapy: Generally 25 to 50 mg injected intramuscularly (IM) 2 to 3 times per week. Titrate to desired serum levels.

    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 change in maintenance levels. Other regimens call for higher dosages to induce pubertal changes and lower dosages 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 generally within the lower ranges and only 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 WARNINGS).

    Palliation of Mammary Cancer in Women: Generally a dosage of 50 to 100 mg is administered intramuscularly (IM) 3 times per week. Some physicians prefer short acting testosterone esters for treatment of breast carcinoma during the initiation of therapy for ease of titration and to better assess patient tolerance of the medication. Women with metastatic breast carcinoma must be followed closely because androgen therapy has been reported in rare instances to accelerate the disease.

    Postpartum Breast Engorgement:

    Generally 25 to 50 mg administered intramuscularly (IM) for 3 to 4 days beginning therapy at the time of delivery.