DOSAGE AND ADMINISTRATION
ANDROXY™ (Fluoxymesterone Tablets, USP), for oral administration, may be given as a single daily
dose or in divided doses. Dosage and duration of therapy will depend on age, sex, diagnosis, patient's
response to treatment, and appearance of adverse effects. The following recommendations will serve as
a guide to therapy with ANDROXY™ Tablets.
In Males With Delayed Puberty
Various dosage regimens have been used, some call for lower dosages initially with gradual increases
as puberty progresses, with or without a decrease to maintenance levels. Other regimens call for higher
dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological
and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting
the dose. Dosage is within the range of 2.5 to 20 mg daily, although generally in the lower range of 2.5
to 10 mg daily, and for a limited duration, for example 4 to 6 months. X-rays should be taken at
appropriate intervals to determine the amount of bone maturation and skeletal development (see INDICATIONS, and WARNINGS).
As replacement therapy, i.e., for eunuchism, a daily dose of 5 to 20 mg is suggested. It is usually
preferable to start therapy at a higher level within the range (e.g., 10 mg), with subsequent adjustment as
Palliation Of Inoperable Mammary Cancer In Women
A daily dose of 10 to 40 mg, given in divided doses, is recommended. To determine if there will be an
objective response, treatment should be continued for three months or more. Patients must be followed
closely because androgen therapy occasionally appears to accelerate the disease. Thus, many experts
prefer to use a shorter acting androgen preparation, such as ANDROXY™ Tablets, rather than those
with prolonged activity, particularly during the early stages of androgen therapy.
In Palliation Of Advanced Mammary Carcinoma
Hormone therapy is adjunctive to and not a replacement for conventional therapy. Duration of therapy
will depend on the response of the condition and the appearance of adverse reactions.
ANDROXY™ (Fluoxymesterone Tablets, USP) 10 mg are round, green, scored compressed tablets
debossed with 832 and 86 and are available in bottles of 100.
Dispense in a tight, light-resistant container as defined in the USP.
Store at controlled room temperature 15 – 30°C (59 - 86°F).
Keep out of reach of children.
Manufactured by: UPSHER-SMITH LABORATORIES, LLC. Maple Grove, MN 55369. Revised: September 2017.