Home SustaTrex®350

SustaTrex®350 10ml vial

Testosterone MIX 350mg/ml, 10 mL Multidose Vial



Therapeutic Class:
Anabolic Agent


Each 1 ml of SUSTATREX350 contains

Testosterone propionate 60 mg/ml

Testosterone phenylpropionate 90 mg/ml

Testosterone isocaproate 90 mg/ml

Testosterone decanoate 110 mg/ml

Ethlyl Oleate q.s.

For Intramuscular Administration

Indication & Dosage:


Male hypogonadism

50-400 mg every 2-3 wk for the testosterone mix
50-400 mg every 2-4 wk for the cypionate;

50-400 mg every 2-4 wk for the enanthate
(or an initial  dose of 250 mg every 2-3 wk followed
by a maintenance dose every 3-6 wk);

up to 50 mg 2-3 times wkly for the propionate.

Inoperable metastatic breast cancer

As test.mix: 200-400 mg every 2-4 wk.
As enanthate: 200-400 mg every 2-4 wk.


Hypercalcaemia or hypercalciuria, males with breast or prostate carcinoma.
Pregnancy and lactation.
    Special Precautions          
Cardiovascular disorders, skeletal metastases, renal or hepatic impairment,
epilepsy, migraine, diabetes or other conditions which may be aggravated by
fluid retention, eg heart failure. Elderly, prepubertal boys. Monitor signs of
virilization (females) and development of priapism or excessive sexual stimulation
(males). Periodic haemoglobin, lipid determinations and rectal prostate examination.
    Adverse Drug Reactions   
Fluid and electrolyte retention; increased vascularity of the skin; hypercalcaemia,
impaired glucose tolerance; increased bone growth and skeletal weight; increase

LDL cholesterol; increase haematocrit and fibrinolytic activity; headache, depression and GI bleeding.
Males: spermatogenesis suppression, priapism, gynaecomastia,

prostatic hyperplasia and accelerate growth of malignant prostate neoplasms.

Females: suppression of lactation, ovarian activity and menstruation; virilization,

clitoris hypertrophy, increased libido, oily skin, acne, hirsutism, male pattern baldness.

Children: Closure of the epiphyses and stop linear growth in early

puberty, symptoms of virilisation. Precocious sexual development, increased

frequency of erection in boys, and clitoral enlargement in girls. IM: urticaria,

inflammation at Inj site, postinjection induration, furunculosis
Potentially Fatal: Peliosis hepatis, liver toxicity, malignant neoplasm.

    Drug Interactions               
Enhance activities of ciclosporine, antidiabetics, thyroxine, anticoagulants.
Long term use of testosterone may cause resistance to effects of neuromuscular
 blockers. Enhance fluid retention from corticosteroids.
    Lab Interference                
May decrease protein bound iodine (PBI) and thyroxine-binding globulin
concentrations. May cause a decrease in excretion of creatinine and creatine
and increase in excretion of 17-ketosteroids.                                                    

    Pregnancy Category
Category X: Studies in animals or human beings have demonstrated foetal

abnormalities or there is evidence of foetal risk based on human experience

or both, and the risk of the use of the drug in pregnant women clearly

outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

    Mechanism of Action         
Testosterone is the principal endogenous androgen responsible for promoting

the growth and development of male sexual organs and maintaining secondary

sex characteristics in androgen-deficient males.

Absorption: Absorbed from GI tract, skin, and oral mucosa

Distribution: 80% bound to sex-hormone binding globulin.
Undergo enterohepatic recirculation.
Half-life of testosterone: 10 to 100 min.

Metabolism: Hepatic to active and inactive metabolites.

Excretion: Excreted via urine as metabolites; and faeces as unchanged drug (6%)

CIMS Class : Androgens & Related Synthetic Drugs

ATC Classification: G03BA03 – testosterone ; Belongs to
the class of 3-oxoandrosten (4) derivative androgens used
in androgenic hormone preparations.


Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Store away from heat, moisture, and light.

Do not store in the bathroom. Keep out of the reach of children and away from pets.

Concentrex Laboratiories N. V., Moerstraat 58, 9031, Gent, Belgium

Reg. No. Licence: 253/55-C9/2010/BE
Manufactured under WHO cGMP guidelines
Date of Preparation : 19 july 2010