Testosterone Undecanoate capsules
Active Ingredients:
Each soft gelatin capsule contains 40 mg testosterone undecanoate
dissolved in oleic acid.
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 Testosterone Undecanoate capsules increases plasma
levels of testosterone and its active metabolites.
INDICATIONS
Testosterone replacement therapy in male hypogonadal
disorders, for example:
- |
after castration; |
- |
eunuchoidism; |
- |
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:
testosterone undecanoate 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:
- |
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, 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.
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