INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TESTOSTERONE Implants 25 mg
TESTOSTERONE Implants 200 mg

        RU 1530.011.002

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

TESTOSTERONE Implants 25 mg
TESTOSTERONE Implants 200 mg

COMPOSITION
Each pellet contains:
25 mg or 200 mg
testosterone.

PHARMACOLOGICAL CLASSIFICATION
A/21.7/ Male sex hormones

PHARMACOLOGICAL ACTION
Testosterone pellets, when inserted subcutaneously, provide a slow release of the natural androgenic hormone, testosterone. The 200-mg implants usually maintain plasma testosterone levels within the normal psychological range for 4 to 5 months.

INDICATIONS
Testosterone replacement therapy in male hypogonadal disorders, for example:
- after castration;
- eunuchoidism;
- hypopituitarism.
Moreover, testosterone may be indicated in osteoporosis due to hypogonadal male androgen deficiency.

CONTRA-INDICATIONS
- Known or suspected mammary or prostatic carcinoma in the male.
- Impaired hepatic function and hypercalcaemia.
- This medicine is not intended for use in female patients.

WARNINGS
Middle aged and elderly males with angina pectoris and other severe circulatory disease should receive androgen therapy only under very careful supervision.

DOSAGE AND DIRECTIONS FOR USE
100 to 600 mg depending on individual requirements.
A dosage of 600 mg (3x 200 mg) usually maintains plasma testosterone levels within the normal physiological range for 4-5 months.
Since the rate of release of the active substance depends on the surface area of the pellet, the daily dosage is not only determined by the total implanted dose but also by the number of separate implants sited on separate tracts.
Administration:
Testosterone Implants should be inserted subcutaneously (either by using a trocar and canula or by open surgery), into an area where there is relatively little movement, such as the lower abdominal wall or the buttock. Insertion is made under local anaesthesia and the wound is closed either with an adhesive dressing or a fine suture.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following adverse reactions have been associated with androgen therapy:
- Priapism and other signs of excessive sexual stimulation.
- Oligospermia and decreased ejaculatory volume.
- Water and salt retention.
In prepubertal boys, androgen therapy is problematic as precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure may occur.
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 sodium and fluid retention.
A decrease in protein-bound iodine (PBI) may occur, but this has no clinical significance.
Precaution should be taken to avoid the formation of haematoma at the insertion site of the implant.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See "Side Effects and Special Precautions".
Symptomatic treatment should be instituted.

CONDITIONS OF REGISTRATION
The product to be advertised to the professions only.

IDENTIFICATION
Cylindrical pellets of fused crystalline hormone.
The 25-mg implant has a diameter of 2,2 mg and the 200-mg implant has a diameter of 4,5 mm.

PRESENTATION
Each sterile implant is supplied singly, in a sealed glass tube, held in place by white non-absorbent wool. Available containing 25 mg or 200 mg testosterone.

STORAGE DIRECTIONS
The implants must be kept below 30°C and must be protected from light. Keep out of reach of children.

REFERENCE NUMBER
G3210 (Act 101/1965): Testosterone 25-mg implants
G3212 (Act 101/1965): Testosterone 200-mg implants

NAME AND BUSINESS ADDRESS OF THE APPLICANT
DONMED PHARMACEUTICALS (PTY) LIMITED
Donmed House
Cambridge Place
Cnr Kirkby & Oxford Roads
Bedfordview 2007

DATE OF PUBLICATION OF THIS PACKAGE INSERT
July 1987

Under license of NV Organon, The Netherlands

Updated on this site: May 2004
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004