Testosterone Combination Injection

(Intramuscular Injection 250mg/1ml)

Description

Each 1 ml. of Testosterone Combination contains Testosterone Propionate 30 mg. Testosterone Phenylpropionate 60 mg. Testosterone Isocaproate 60 mg. Testosterone Decanoate 100 mg. in Oily base. Ethyl oleate quantity sufficient and Benzyl alcohol.

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 Testostero ne 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 tr eatment with Testosterone Combination results in a normalization of pituitary function.

Pharmacokinetics

Testosterone Combination contains a number of esters of testosterone with different durations of action. The esters are hydrolyzed 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 24-48 hrs (tm.. ) 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 metabolized via the normal path ways. Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.

Dosage and Administration

In general, dosage should be adjusted to the individual response 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 less frequent doses may achieve the same response.

Female-ta-male transsexuals

Different specialist centers 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 Hyper sensitivity to the active substance or to any of the excipient.

Warnings

Patients, especially the elderly, with the following conditions should be monitored: ischaemic heart disease, since androgens may produce hypercholesterolaemia. latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions), since androgens may occasionally induce fluid and sodium retention. skeletal metastases, since androgens may induce hypercalcaemia or hypercalciuria in these patients, signs of osteoporosis, changes in lipid profile.

Adverse effects

The following adverse reactions have been associated with androgen therapy in general: In prepubertal boys, precocious sexual development, an increased frequency of erections, phallic enlarge- ment and premature epiphyseal closure; Priapism and other signs of excessive sexual stimulation; Water and sodium retention; Oligospermia and a decreased ejaculatory volume. Treatment should be interrupted until these symptoms have disappeared, after which it should be continued at a lower dosage. Hoarseness of the voice may be the first symptom of vocal change which may lead to irreversible lowering of the voice. If signs of virilisation develop, particularly lowering of the voice, treatment should be discontinued unless the effects are desired treatment outcomes. The following undesirable effects have also been observed: acne, disturbance of liver function, polycythaemia, hypertension, weight gain (in female-to-male transsexuals)

Drug interactions

Enzyme-inducing agents may exert increasing or decreasing effects on testosterone levels. Therefore, adjustment of the dose, and/or intervals between injections may be required. Pregnancy and lactation: On the basis of its pharmacological effect, Testosterone Combination is suspected to cause birth defects and/or other irreversible adverse effects on pregnancy outcome. Therefore, Testosterone Combination is contraindicated during pregnancy and lactation. Dosage and directions for use Total doses above 400 mg per month are not required because of the prolonged action of the preparation. Injections more frequently than every two weeks are rarely indicated. Use of a wet needle or wet syringe may cause the solution to become cloudy; however, this does not affect the potency of the material. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Testosterone Enanthate injection is a clear, colorless to pale yellow solution.

Overdose

The acute intramuscular toxicity of Testosterone Combination is very low. Priapism in men is a symptom of chronic overdose. If this occurs, Testosterone Combination treatment should be interrupted and, after disappearance of the symptom, be resumed at a lower dose.

Storage

Store in cool dry place below 30°C, Protect from light. Keep out of reach of children.

Presentation

10 ml. vial is packed in a carton tray. Each carton tray includes 10 ml. vial and information leaflet.