DESCRIPTION

TESTAVIS.E200 is an oil based solution of testosterone
enanthate for IM injection designed

to release testosterone slowly from the injection site.
Testosterone serum concentrations

remain elevated for 7 – 10 days after IM administration.
TESTAVIS.E200 is suitable for the

treatment of hypogonadism and other disorders related to
androgen deficiency.

TESTAVIS.E200 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: TESTAVIS.E200 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
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 erythropoietic 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 repor ted 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.

In a study of healthy males, a single injection of 200 mg of
testosterone cypionate increased

mean serum testosterone concentrations sharply to 3 times
the basal levels (approximately

1350 ng/dl) at 24 hours and declined gradually to basal
levels (approximately 500 ng/dl) by

day 10.

Circulating testosterone is chiey bound in the serum to sex
hormone-binding globulin

(SHBG) and albumin. Testosterone is metabolized to various
17-keto steroids through two

different pathways. The major active metabolites of
testosterone are estradiol and

dihydrotestosterone. Testosterone is metabolized to DHT by
steroid 5-alpha reductase

located in the skin, liver, and the urogenital tract of the
male. DHT binds with greater affinity to

SHBG than does testosterone.

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 especially when androgens

are 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.

Dihydrotestosterone & 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 habits.

DOSAGE AND ADMINISTRATION

Adult Male: 150 – 300mg injected IM every 1 to 2 weeks or as
directed by physician.

PRESENTATION

TESTAVIS.E200(200mg/ml) in 10 ampules of 1ml each.