TM-250

DESCRIPTION

TM-250 is clear, colorless 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 TM-250 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 TM-250 results in a normalization of pituitary function.

Pharmacokinetics
TM-250 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 TM-250 in males leads to an increase of total plasma testosterone, with peak level reached approximately 24-48 hrs after administration. Plasma testosterone levels return to the lower limit of the normal range in males after approximately 21 days.

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 requent doses may achieve the same response.

Contraindications
Known or suspected prostatic or mammary carcinoma;
Pregnancy Breast-feeding
Hypersensitivity to the active substance or to any of the excipients
Warnings
Patients, especially the elderly, with the following conditions should be monitored:
– ischemic 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,

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 enlargement 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.

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.
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.

How is Supplied
TM-250 (Testosterone Mix) Injection, 250 mg per ml is available in vials of 1 ml, in cartons of 10. Store at 20° to 25°C (68° to 77°F). PROTECT FROM LIGHT. Store in carton until contents are used.