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
Androderm Indications, Dosage, Storage, Stability - Testosterone Transdermal System
Androderm Indications, Dosage, Storage, Stability - Testosterone Transdermal System
Androderm (testosterone transdermal system) is indicated for testosterone
replacement therapy in men
for conditions associated with a deficiency or absence
of endogenous testosterone.
Primary hypogonadism
(congenital or acquired) Testicular failure
due to cryptorchidism, bilateral
torsion, orchitis, vanishing testis
syndrome, or orchidectomy. Klinefelter’s syndrome,
chemotherapy, or toxic
damage from alcohol or heavy
metals. These men usually have low serum
testosterone concentrations accompanied by gonadotropins (FSH, LH) above
the normal range.
Secondary, i.e., hypogonadotropic hypogonadism
(congenital or acquired) idiopathic gonadotropin
or luteinizing hormone-releasing hormone
(LHRH) deficiency, or pituitary-hypothalamic injury
from tumors, trauma, or radiation. These men have low serum
testosterone concentrations
without associated elevation in gonadotropins. Appropriate adrenal
cortical and thyroid
hormone replacement therapy
may be necessary in patients with multiple
pituitary or hypothalamic abnormalities.
DOSAGE AND ADMINISTRATION |
The usual starting dose is one
Androderm 5 mg system
or two Androderm 2.5 mg systems
applied nightly for 24 hours, providing a tote1 dose
of 5 mglday.
The adhesive side
of the Androderm system should
be applied to a clean, dry area
of the skins on the back, abdomen,
upper arms, or thighs. Avoid application over bony
prominences or on a p.r. of the
b.d. that may be subject to prolonged
pressure during sleep
or sitting (e.g., the deltoid region of the upper arm, the greater trochanter
of the femur, and the ischial tuberosity. DO NOT APPLY TO
THE SCROTUM. The sites of application should be rotated, with an interval
of 7 days between applications to the same site. The area
selected should not be oily, damaged, or irritated. (See Table 2.)
The system should be applied
immediately after opening
the pouch, and removing the protective
release liner. The System
should be pressed firmly in place, making sure there is good contact
with the skin, especially around
the edges.
To ensure proper dosing, the morning serum
testosterone concentration
may be measured following system
application the previous evening. If the serum concentration
is outside the normal range,
sampling should be repeated
with assurance of proper system
adhesion as well as appropriate
application time. Confirmed serum
concentrations outside the normal
range may require increasing
the daily dose to 7.5 mg
(i.e., one 5 mg and,one 2.5 mg
systems or three 2.5 mg systems)
or decreasing the daily dose
to 2.5 mg (i.e., one 2.5 mg
system), maintaining nightly application. Because of variability in analytical
values among diagnostic
laboratories, this laboratory
work and any later analyses for assessing the effect
of Androderm therapy, should
be performed at the same laboratory
so results can be compared.
Androderm (testosterone transdermal system) therapy
for nonvirlized patients may be initiated with one 2.5 mg/day system
app1ied nightly.
Androderm (testosterone transdermal system) 2.5 mg/ day.
Each system contains 12.2
mg testosterone
USP for delivery of 2.5
mg of testosterone
per day (see DESCRIPTION).
Cartons of 60 systems NDC 0007-3155-18
Androderm (testosterone transdermal system) 5 mg/day.
Each system contains 24.3
mg testosterone
USP for delivery of 5 mg
of testosterone per day (see
DESCRIPTION). Cartons of 30 systems
NDC 0007-3156-l3
Storage and Disposal
Store at room temperature, 15o
to 30oC (59o to 86oF). Apply to skin
immediately upon removal from the protective pouch. Do not store outside
the pouch provided. Damaged
systems should not be used. The drug
reservoir may be burst by
excessive pressure or heat.
Discard systems in household trash in a manner that prevents accidental
application or ingestion
by children, pets or others.
REFERENCES
- Mazer NA, et al. Mimicking the circadian
pattern of testosterone
and metabolite levels with an enhanced transdermal delivery
system. In Gurney, Junjinger,
Peppas. eds. Pulsatile Drug Delivery.. Current Applications and future
Trends. Stuttgart: Wiss. Verl.-Ges.; 1993, 73-97.
- Schroeder FH. Androgens and carcinoma
of the prostate. In Neischlag
E, Behre HM, eds. Testosterone Action, Deficiency, Substitution. Berlin/Heidelberg:
Springer-Verlag; 1990, 245-260. CAUTION: Federal law
prohibits dispensing with-out prescription.
Copyright ©SmithKline Beecham
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