Presentation and Status in Health Basket
30 X 40 mg
Adults: The initial dosage required will usually be120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.
Children: Safety and efficacy have not been adequately determined in children. Method of administration: To ensure absorption, Androxon Testocaps must be taken with a meal, if necessary with a little fluid and swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. In general, the dose should be adjusted according to the response of the individual patient.
Testosteronic replacement therapy in male hydrogonadal disorders.
History or presence of prostatic cancer or breast cancer; Hypersensitivity to the active substance or to any of the excipients.
Physicians should consider subjects receiving Androxon Testocaps for monitoring before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters: digital rectal examination (DRE) of the prostate and PSA, hematocrit and hemoglobin to exclude polycythemia. In patients with preexisting cardiac, renal or hepatic disease androgen treatment may cause complications characterized by edema with or without congestive heart failure. Androgens in general and Androxon Testocaps can improve the glucose tolerance and the anticoagulant action. There is insufficient evidence for a recommendation regarding the safety of treatment with testosterone esters in men with sleep apnea. Good clinical judgment and caution should be employed in subjects with risk factors such as adiposity or chronic lung diseases. In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Androxon Testocaps in high dosages may accelerate epihyseal closure and sexual maturation. If androgen associated adverse reactions occur, treatment with Androxon Testocaps should be discontinued and /or resumed with a lower dose.
Neoplasms benign, malignant and unspecified (incl. cysts and polyps): Prostatic cancer.
Blood and lymphatic system disorders: Polycythaemia.
Metabolism and nutrition disorders: Fluid retention Psychiatric disorders Depression, nervousness, mood disturbances, libido increased, libido decreased Musculoskeletal and connective tissue disorders: Myalgia.
Vascular disorders: Hypertension.
Gastrointestinal disorders: Nausea.
Skin and subcutaneous tissue disorders: Pruritus, acne.
Reproductive system and breast disorders: Gynaecomastia, oligozoospermia, priapism, prostatic disorder.
Investigations: Hepatic function test abnormal, lipids abnormal3, PSA increased.
Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may Increase testosterone levels. Therefore adjustment of the dose of Androxon Testocaps may be required. Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines Androgens may enhance the anticoagulant action of coumarine type agents allowing a reduction of the dose of these agents. Androxon Testocaps must be taken with a meal to ensure absorption.
The acute toxicity of testosterone low. An overdose of Androxon Testocaps may cause gastrointestinal complaints due to castor oil. Treatment consist of supportive measures.