Presentation and Status in Health Basket
Sachet: 30 X 25 mg
Sachet: 30 X 50 mg
Adults & elderly men: The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily, at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5g of gel steps. The application should be administrated by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms or abdomen. After opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin. The gel has just to be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least 3-5 minutes before dressing .Wash hands with soap and water after application. Do not apply to the genital areas as the high alcohol content may cause local irritation. Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment by Testomax. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application and from the 3rd day on after starting treatment (one week seems reasonable). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day.
Children: Testomax is not indicated for use in children and has not been evaluated clinically in males under 18 years of age.
Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Not indicated for use in children and has not been evaluated clinically with males under 18 years. Known or suspected breast cancer or prostatic cancer. Known hypersensitivity to testosterone or any other constituents of the gel. Has not been evaluated for women and should thus not be used in women. May have adverse virilizing effects on the fetus.
There are rare reports of hepatocellular carcinoma in patients receiving long-term oral therapy with androgens in high doses. In patients suffering from severe cardiac, hepatic or renal insufficiency, treatment may cause severe complications characterized by edema with or without congestive cardiac failure. In this case, treatment must be stopped immediately. Ischemic heart disease. Hypertension. Should not be used if testosterone insufficiency has not been demonstrated and if other etiology, responsible for the symptoms, has not been excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features. Not a treatment for male sterility or impotence. Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia. Patients suffering from cancer and having a risk of hypercalcaemia (and hypercalciuria) associated, due to bone metastases. Regular monitoring of serum calcium concentration is recommended in these patients. Hematocrit determination should be checked periodically in patients having a long-term androgen treatment. Improved insulin sensitivity may occur. Epilepsy and migraine may be aggravated. There are published reports on an increased risk of sleep apnea in hypogonadal patients treated, especially in those with risk factors such as obesity and chronic respiratory disease. Clinical signs such as irritability, nervousness, weight increase, prolonged or frequent erection may indicate excessive androgen exposure. May produce a positive reaction in anti-doping tests. All patients, and especially elderly patients and exposed risk patients (those with clinical or family factors), must undergo a detailed examination in order to exclude any risk of pre-existing prostatic cancer. Regular monitoring of the prostate gland and breast must be performed. Hemoglobin and hematocrit levels should be checked periodically in patients on long-term androgen therapy. Liver function, prostatic specific antigen, cholesterol, and high-density lipoprotein should be checked periodically. Serum testosterone concentrations should be measured.
Skin reaction at the application area, erythema, acne, dry skin. Headaches, alopecia, gynecomastia, mastodynia, prostatic disorders, diarrhea, dizziness, asthenia, hypertension, mood disorders, changes in laboratory tests (polycythemia, etc.), reduced libido, hyperesthesia, paraesthesia. Other known adverse effects are prostatic changes and progression of sub-clinical prostatic cancer, pruritis, arterial vasodilatation, nausea, cholestatic jaundice, changes in liver function tests and , during high-dose long-term treatment, electrolyte changes (sodium, potassium, calcium, inorganic phosphate and water retention), oligospermia and priapism (frequent or prolonged erection).
For full details see prescribing information.
Oral anticoagulants: Changes in anticoagulant activity (the increased effect of the oral anticoagulant by modification of coagulation factor hepatic synthesis and competitive inhibition of plasma protein binding): Increased monitoring of the prothrombin time and INR determinations are recommended. Patients receiving oral anticoagulants require close monitoring especially when androgens are started or stopped.
Corticosteroids: The concurrent administration of testosterone and ACTH or corticosteroids may increase the risk of developing edema. As a result, these medicinal products should be administered cautiously, particularly in patients suffering from cardiac, renal or hepatic disease.
Interaction with laboratory test: Androgens may decrease levels of thyroxin binding globulin, resulting in decreased T4 serum concentrations and in increased resin uptake of T3 and T4. Free thyroid hormone levels, however, remain unchanged and there is no clinical evidence of thyroid insufficiency.
Pregnancy and Lactation
Testomax is intended for use by men only. Testomax is not indicated in pregnant or breast feeding women. No clinical trials have been conducted with this treatment in women. Pregnant women must avoid any contact with Testomax application sites. This product may have adverse virilizing effects on the foetus. In the event of contact, wash with soap and water as soon as possible.
Only one case of acute testosterone overdose following an injection has been reported in the literature. This was a case of a cerebrovascular accident in a patient with high plasma testosterone concentration of 114ng/ml (395nmol/l). It would be most unlikely that such plasma concentration be achieved using the transdermal route.