Testosterone Combination
(Intramuscular Injection 250mg/ml)
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.
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 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. 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.
Preservation
Keep out of the reach and sight of children. Do not store above 30°C. Keep in the original package or container supplied. Do not use this product after the expiry date that is stated in the outer package. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Presentation
5 ampoules are packed in a plastic tray. 2 such trays are packed in carton box. All pack sizes may not be marketed.