TESTAVIS.P25 is an oil based solution of testosterone
propionate for IM injection designed
to reach peak testosterone serum levels within 24 hours of
IM administration and remain
elevated for 2 to 3 days. TESTAVIS.P25 is suitable for the
treatment of hypogonadism and
other disorders related to androgen deficiency. TESTAVIS.P25
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.
Adult Males: TESTAVIS.P25 Injection is indicated for
replacement therapy in conditions
associated with a deficiency or absence of endogenous
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
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
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,
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
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
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 chiey bound in the serum to sex
(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.
Male: Gynecomastia, excessive frequency and duration of
penile erections, oligospermia.
Skin and Appendages: Hirsutism, male pattern baldness and
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
Other: Serum lipid changes, hypercalcaemia, hypertension,
oedema, priapism, and
potentiation of sleep apnea.
Patients with known hypersensitivity to any ingredients in
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
Products containing testosterone should not be used in women
as they may cause
virilization and fetal harm.
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.
Serum Cholesterol, HDL, LDL, TG. Hemoglobin and Hematocrit,
Hepatic function tests –
Prostatic specific antigen – PSA, Testosterone: total, free,
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: 50 – 100mg injected IM every 2 to 3 days or as
directed by physician.
TESTAVIS.P25 (25mg/ml) 10 ampules of 1ml each.
|Each ml contains: