TESTOSTERONE ENANTHATE (250 MG/ML – 10 ML)

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.