TESTOSTERONE Combination

Description

Testosterone Combination is clear, colourless oily liquid of Testosterone Esters for Intramuscular use. Each ml contains Testosterone Propionate 30 mg, Testosterone Phenylpropionale 60 mg, Testosterone Isocaproate 60 mg and Testosterone Decanoate 100 mg.

Pharmacodynamics
Testosterone is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life testosterone is essential for the functioning of the testes and accessory structures, and for the maintenance of libido, sense of well-being, erectile potency, prostate and seminal vesicle function. Treatment of hypogonadal males with Testosterone Combination results in a clinically significant rise of plasma, concentrations of testosterone,dihydrotestosterone and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). In the males with primary (hypergonadotropic) hypogonadism treatment with Testosterone Combination results in a normalisation of pituitary function.

Pharmacokinetic
Testosterone Combination contains a number of esters of testosterone with different durations of action. The esters are hydrolysed into the natural hormone testosterone, as soon as they enter the general circulation. A single dose of Testosterone Combination in males leads to an increase of total plasma testosterone, with peak level reached approximately 24-48hrs (tmax) after administration. Plasma testosterone levels return to the lower limit of the normal range in males after approximately 21 days. In female-to-male transsexuals, a single dose of Testosterone Combination repeated every two weeks resulted in mean trough testosterone levels towards the upper end of the normal male range at 2,4 and 12 months. Testosterone is metabolised via the normal pathways. Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.

Dosage and Administration
In general, dosageshouldbe adjustedto the individualresponse of the patient. Adults: Usually, one injection of 1ml per three weeks is adequate. Elderly: It should be noted that smaller and less frequent doses may achieve the same response. Children: It should be noted that smaller and lessirequent doses may achieve the same response. Female-to-male transsexuals: Different specialist centres have used doses varying from one injection of 1ml every two weeks to one injection of 1ml every four weeks. Administration Deep intramuscular injection

Contraindications
Known or suspected prostatic or mammary carcinoma; Pregnancy Breast-feeding Hypersensitivity to the active substance or to any of the excipients.