A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Testred Indications, Dosage, Storage, Stability - Methyltestosterone
Testred Indications, Dosage, Storage, Stability - Methyltestosterone
INDICATIONS
Males
Androgens are indicated for replacement
therapy in conditions
associated with a deficiency
or absence of endogenous
testosterone:
a. Primary hypogonadism
(congenital or acquired) — testicular
failure due to cryptorchidism, bilateral
torsions, orchitis, vanishing testis
syndrome; or orchidectomy.
b. Hypogonadotropic hypogonadism
(congenital or acquired) — idiopathic gonadotropin or LHRH
deficiency, or pituitary
hypothalamic injury
from tumors, trauma, or radiation. If the above conditions occur
prior to puberty, androgen replacement
therapy will
be needed during the adolescent
years for development
of secondary sexual
characteristics. Prolonged androgen treatment will
be required to maintain sexual
characteristics in these and other males who develop testosterone
deficiency after
puberty.
c. Androgens may be used to stimulate
puberty in carefully
selected males with clearly delayed puberty. These patients usually
have a familial pattern of delayed puberty
that is not secondary
to a pathological disorder; puberty is expected to occur spontaneously
at a relatively late date. Brief treatment with conservative
doses may occasionally be justified in these patients if they
do not respond to psychological
support. The potential adverse effect
on bone maturation
should be discussed with the patient and parents prior to androgen
administration. An X-ray
of the hand and wrist
to determine bone age
should be obtained every 6 months to assess the effect
of treatment on
the epiphyseal centers (see WARNINGS).
Females
Androgens may be used secondarily in women with advancing inoperable
metastatic (skeletal) mammary
cancer who are 1 to 5
years postmenopausal. Primary goals of therapy
in these women include ablation
of the ovaries. Other methods of counteracting estrogen
activity are adrenalectomy,
hypophysectomy, and/or antiestrogen
therapy. This treatment
has also been used in premenopausal women with breast
cancer who have benefitted
from oophorectomy
and are considered to have a hormone-responsive tumor. Judgment
concerning androgen therapy should be made by an oncologist
with expertise in this field.
DOSAGE AND ADMINISTRATION
Methyltestosterone capsules are administered orally. The suggested
dosage for androgens varies depending on the age, sex,
and diagnosis of the
individual patient. Dosage is adjusted according to the patient’s
response and the appearance
of adverse reactions.
Replacement therapy
in androgen-deficient males is 10 to 50 mg
of methyltestosterone daily. Various dosage
regimens have been used to induce pubertal
changes in hypogonadal males, some experts have advocated lower
dosages initially, gradually increasing the dose
as puberty progresses
with or without a decrease to maintenance levels. Other experts
emphasize that higher dosages are needed to induce pubertal
changes and lower dosages can be used 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.
Doses used in delayed puberty
generally are in the lower range
of that given above, and for a limited duration, for example 4 to
6 months.
Women with metastatic breast
carcinoma must be
followed closely because androgen therapy
occasionally appears to accelerate the disease. Thus, many experts
prefer to use the shorter acting androgen
preparations rather than those with prolonged activity
for treating breast carcinoma,
particularly during the early stages of androgen
therapy. The dosage of
methyltestosterone for androgen
therapy in breast
carcinoma in females
is from 50-200 mg daily.
HOW SUPPLIED
Methyltestosterone capsules USP 10 mg
are red capsules imprinted
“ICN 0901” on both sections. They are available in bottles of 100.
Store at 25°C (77°F); excursion permitted to 15°C - 30°C (59°F - 86°F).
CAUTION: Federal (USA) law
prohibits dispensing without prescription.
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