ConcenTrex PROPITREX 10ml 150mg/ml

Description

Manufacturer: ConcenTrex

Composition:

Each 1 ml of PROPITREX150 contains:

- 150 mg Testosterone Propionate

- Ethyl Oleate q.s.

For Intramuscular Administration

Indication & Dosage:

Intramuscular

**Male Hypogonadism:**

Adult: 

- 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 weekly for the propionate.

**Inoperable Metastatic Breast Cancer:**

Adult: 

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

Contraindications:

- Hypercalcaemia or hypercalciuria.

- Males with breast or prostate carcinoma.

- Pregnancy and lactation.

Special Precautions:

Exercise caution in patients with cardiovascular disorders, skeletal metastases, renal or hepatic impairment, epilepsy, migraine, diabetes, or other conditions aggravated by fluid retention (e.g., heart failure). Monitor signs of virilization in females and development of priapism or excessive sexual stimulation in males. Conduct periodic haemoglobin, lipid determinations, and rectal prostate examinations.

Adverse Drug Reactions:

- Fluid and electrolyte retention.

- Increased vascularity of the skin.

- Hypercalcaemia.

- Impaired glucose tolerance.

- Increased bone growth and skeletal weight.

- Increased LDL cholesterol.

- Increase haematocrit and fibrinolytic activity.

- Headache, depression, and GI bleeding.

Males may experience spermatogenesis suppression, priapism, gynaecomastia, prostatic hyperplasia, and accelerated growth of malignant prostate neoplasms. Females may experience suppression of lactation, ovarian activity, and menstruation, as well as virilization, clitoris hypertrophy, increased libido, oily skin, acne, hirsutism, and male pattern baldness. Children may experience closure of the epiphyses and cessation of linear growth in early puberty, symptoms of virilization, precocious sexual development, increased frequency of erection in boys, and clitoral enlargement in girls. Injection site reactions include urticaria, inflammation, post-injection induration, and furunculosis. Potentially fatal reactions include peliosis hepatis, liver toxicity, and malignant neoplasms.

Drug Interactions:

Testosterone may enhance the activities of ciclosporine, antidiabetics, thyroxine, anticoagulants, and corticosteroids. Long-term use of testosterone may cause resistance to neuromuscular blockers.

Lab Interference:

Testosterone may decrease protein-bound iodine (PBI) and thyroxine-binding globulin concentrations, and cause a decrease in excretion of creatinine and creatine, and an increase in excretion of 17-ketosteroids.

Pregnancy Category:

Category X: Testosterone is contraindicated in pregnant women due to the risk of fetal abnormalities.

Mechanism of Action:

Testosterone promotes the growth and development of male sexual organs and maintains secondary sex characteristics in androgen-deficient males. It is absorbed from the GI tract, skin, and oral mucosa, with 80% bound to sex-hormone binding globulin. Testosterone undergoes enterohepatic recirculation, with a half-life of 10 to 100 minutes. It is metabolized hepatically to active and inactive metabolites, and excreted via urine as metabolites and feces as unchanged drug (6%).

Storage:

Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Keep away from heat, moisture, and light. Avoid storing in the bathroom, and keep out of the reach of children and pets.