Description Testosterone Enanthate Strength: 250mg/ml Molecular Formula: C28H4003 Molecular Weight: 400.594 g/mol Active Ingredient: Testosterone enanthate CAS number: 315-37-7 Dosage Form: Injectable, oil base sterile solution Route: Injection Market Status: Prescription Company: Hilma Biocare DESCRIPTION Testosterone Enanthate 250 is an oil based solution for IM injection including those of short, intermediate, and long half-lives. Serum testosterone will rapidly increase within 24 hours of IM administration and remain elevated for 7…10 days. Testosterone Enanthate 250 is suitable for the treatment of hypogonadism and other disorders related to androgen deficiency. Testosterone Enanthate 250 has both anabolic and androgenic effects. Testosterone supplementation has been demonstrated to increase strength and growth of new muscle tissue, frequently with increases in libido. INDICATIONS Adult Males: Testosterone Enanthate 250 Injection i 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 hypogona- dism: Idiopathic gönadotropin or LHRH deficiency, or pituitary- hypothalamic injury from tumors. trauma, or radiation. CLINICAL PHARMACOLOGY Testosterone and dihydrotestosterone are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution and have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietin stimulating factor. Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Symptoms associated with male hypogonadism include decreased sexual desire with or without impotence, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics, and osteoporosis. Hypogonadism is a risk factor for osteoporosis in men. 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. During exogenous administration of androgens, endogenous testosterone release may be inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle- stimulating hormone (FSH). Esterification of testosterone at position 17 increases the lipid solubility of the testosterone molecule and prolongs the activity of the molecule by increasing its residence time. Following intramuscular administration in an oily vehicle, testosterone ester is slowly absorbed into the circulation and rapidly hydrolysed in plasma to testosterone. Circulating testosterone is chiety bound in the serum to sex hormone-binding globulin (SHBG) and albumin. Testosterone is metabolized to various 17-ketosteroids through two different pathways. The major active metabolites of testosterone are estradiol and dihydrotestosterone. ADVERSE REACTIONS Male: Gynecomastia, excessive frequency and duration of penile erections, oligospermia. Skin and Appendages: Hirsutism, male pattern baldness and acne, gynecomastia. Fluid/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 hepatitis, hepatic adenomas, and cholestatic hepatitis. Hematologic: Suppression of clotting factors II, V, VII, & X; bleeding in patients on anticoagulant therapy. Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Other: Serum lipid changes, hypercalcaemia, hypertension, oedema, priapism, and potentiation of sleep apnea. CONTRAINDICATIONS Patients with known hypersensitivity to any ingredients in this product. Patients with known or suspected carcinomas of the breast, testis, or prostate. Patients with severe heart disease, liver disease, or kidney disease or with a history of epilepsy. Products containing testosterone should not be used in women as they may cause virilization and fetal harm. PRECAUTIONS 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. Patients on oral anticoagulant therapy require close monitoring when androgens are especially started or stopped. Diabetics: androgens may alter the metabolism of oral hypoglycemic agents or may change insulin sensitivity in patients with diabetes mellitus which may require adjustment of dosage of insulin and other hypoglycemic drugs. PATIENT MONITORING Serum Cholesterol, HDL, LDL, TG. Hemoglobin and Hematocrit, Hepatic function tests – AST/ALT. Prostatic specific antigen – PSA, Testosterone: total, free, and bioavailable. Dihydro- testosterone & Estradiol. Male patients over 40 should undergo a digital rectal examination and evaluate PSA prior to androgen use. Periodic evaluations of the prostate should continue while on androgen therapy, especially in patients with difficulty in urination or with changes in voiding habit. PRESENTATION Testosterone Enanthate 250 mg/ml, 10 ml multiple dose vial. STORAGE Store in a cool dry place between 15 -25°C. Protect from light.