COMPOSITION Each capsule contains 40 mg testosterone undecanoate dissolved in oleic acid.
PHARMACOLOGICAL CLASSIFICATION A 21.7 Male sex hormones
PHARMACOLOGICAL ACTION The active substance is testosterone undecanoate, a fatty acid ester of the natural androgen testosterone.
Testosterone undecanoate is able to bypass the liver via the lymphatic system and is therefore orally active.
Therapy with Androxon® increases plasma levels of testosterone and its active metabolites.
INDICATIONS Testosterone replacement therapy in male hypogonadal disorders, for example:
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after castration;
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eunuchoidism;
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hypopituitarism.
Moreover, testosterone therapy may be indicated in osteoporosis due to hypogonadal male androgen deficiency.
CONTRA INDICATIONS Impaired hepatic function and hypercalcaemia.
Known or suspected mammary or prostatic carcinoma.
WARNINGS Middle aged and elderly males with angina pectoris or other severe circulatory disease should receive androgen treatment only under very careful supervision.
DOSAGE AND DIRECTIONS FOR USE In general, dosage should be adjusted according to the individual response of the individual patient.
Usually, an initial dosage of 120-160 mg daily for 2 to 3 weeks is adequate, followed by a maintenance dosage of 40 120 mg daily. Administration: Androxon® capsules should be taken after meals, with a little fluid if necessary, and swallowed without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an uneven number of capsules is to be taken, the larger dose should be taken in the morning.
SIDE EFFECTS AND SPECIAL PRECAUTIONS The following adverse reactions have been associated with androgen therapy:
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Priapism and other signs of excessive sexual stimulation.
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Oligospermia and decreased ejaculatory volume.
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Water and salt retention.
In prepubertal boys androgen therapy is problematic as precocious sexual development, and increased frequency of erections, phallic enlargement and premature epiphyseal closure may occur. Special precautions: If androgen associated adverse reactions occur, treatment should be interrupted, and after disappearance of the symptoms, be resumed at a lower dosage.
Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be monitored, since androgens may induce salt and fluid retention.
A decrease in protein bound iodine (PBI) may occur, but this has no clinical significance.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT See Side effects and Special Precautions.
Treat symptomatically.
CONDITIONS OF REGISTRATION Advertising to the professions only.
IDENTIFICATION Soft, reddish brown gelatin capsules with the code ‘ORG’on one side and the code ‘DV3' on the reverse side.
PRESENTATION Securitainers with 60 capsules.
STORAGE INSTRUCTIONS For wholesale and pharmacies: Store at 2-8°C.
After dispensing: Store at room temperature, below 30°C, in a dry place, for no longer than 90 days. Protect from light.
Keep out of reach of children.
REGISTRATION NUMBER U/21.7/149
NAME AND BUSINESS ADDRESS OF THE APPLICANT DONMED PHARMACEUTICALS (PTY) LIMITED
Donmed House
Cambridge Place
cnr Kirkby & Oxford Roads
Bedfordview 2008
DATE OF PUBLICATION OF THIS PACKAGE INSERT 16 November 1987
Under license of NV Organon, The Netherlands
Updated on this site: May 2004
Source: Pharmaceutical Industry
ANDROXON® capsules