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
Testoderm Indications, Dosage, Storage, Stability - Testosterone (transdermal)
Testoderm Indications, Dosage, Storage, Stability - Testosterone (transdermal)
INDICATIONS
The TESTODERM® products are indicated
for replacement therapy
in males for conditions associated with a deficiency or absence
of endogenous testosterone:
1. Primary hypogonadism
(congenital or acquired) – testicular failure due to cryptorchidism,
bilateral torsion,
orchitis, vanishing testis syndrome, orchidectomy, Klinefelter’s
syndrome, chemotherapy,
or toxic damage from alcohol
or heavy metals. These men usually have low serum
testosterone levels and gonadotropins (FSH, LH) above the normal
range.
2. Hypogonadotropic hypogonadism
(congenital or acquired) -- idiopathic
gonadotropin or
LHRH deficiency
or pituitary-hypothalamic injury from tumors, trauma, or radiation.
These men have low testosterone serum levels but have gonadotropins
in the normal or low
range.
The TESTODERMâ
products have not been evaluated clinically in males under 18 years
of age.
DOSAGE AND ADMINISTRATION
TESTODERMâ
TTS
One system
is applied at about the same time each day. The adhesive
side of the TESTODERMâ
TTS system should be
placed on a clean, dry area
of skin on the arm, back
or upper buttocks immediately
upon removal from the protective
pouch. DO NOT APPLY TO THE
SCROTUM. The area selected
should not be oily, damaged, or irritated. The system
should be pressed firmly in place with the palm of the hand
for about 10 seconds, making sure there is good contact, especially
around the edges. In the
event that a system should
fall off, the same system
may be reapplied. If the system
comes off after it has
been worn for more than 12 hours and it cannot be reapplied, a new
system may be applied
at the next routine application time. In
either case, the daily treatment schedule
should be continued. The TESTODERMâ
TTS system should be
worn approximately 24 hours and then replaced. To ensure proper
dosing, serum testosterone
concentration
may be measured 2-4 hours after an application of TESTODERMâ
TTS. If the serum testosterone
concentrations are low, the dosing regimen may be increased to 2
systems. Because of variability
in analytical values among diagnostic
laboratories, all testosterone
measurements should be performed at the same laboratory.
TESTODERMâ
and TESTODERMâ
WITH ADHESIVE
Patients should start therapy
with a 6 mg/d system of either TESTODERMâ
or TESTODERMâ WITH ADHESIVE
applied daily; if the scrotal area
cannot accommodate a 6 mg/d system, a 4 mg/d TESTODERMâ
system should be used. One TESTODERMâ
or TESTODERMâ WITH ADHESIVE
system should be placed on clean, dry, scrotal skin. Scrotal hair
should be dry-shaved for optimal skin
contact. Chemical depilatories should not be used (see Patient Information).
TESTODERMâ or TESTODERMâ
WITH ADHESIVE should be worn 22-24 hours.
After 3-4 weeks of daily system
use, blood should be drawn
2-4 hours after system
application for determination
of serum total testosterone.
Because of variability
in analytical values among diagnostic
laboratories, this laboratory
work and later analyses
for assessing the effect
of the TESTODERMâ and TESTODERMâ
WITH ADHESIVE therapy
should be performed at the same laboratory.
If patients have not achieved desired results by
the end of 6-8 weeks of treatment
with any of the TESTODERMâ
products, another form
of testosterone
replacement therapy
should be considered.
HOW SUPPLIED
TESTODERMâ
TTS, TESTODERMâ , and
TESTODERMâ WITH ADHESIVE
testosterone transdermal
systems contain a Schedule III controlled substance as defined by
the Anabolic Steroids Control Act.
TESTODERMâ
TTS
TESTODERMÒ
TTS systems are supplied as individually pouched systems, 30 per
carton. TESTODERMÒ
TTS 5 mg/d (Testosterone Transdermal System) -- each 60 cm2
system contains 328 mg
testosterone USP for nominal dose
of 5 mg/day
Carton of 30 TESTODERMÒ
TTS 5 mg/d systems…………………NDC 17314-4717-3
TESTODERMâ
and TESTODERMâWITH ADHESIVE
TESTODERMÒ
and TESTODERMÒ WITH
ADHESIVE systems are supplied as individually pouched systems, 30
per carton.
TESTODERMÒ
4 mg/d (Testosterone Transdermal System) -- each 40 cm2 system
contains 10 mg testosterone
USP for nominal delivery
of 4 mg for one day.
Carton of 30 TESTODERMÒ
4 mg/d systems………………………….NDC 17314-4608-3
TESTODERMÒ
and TESTODERMÒ WITH
ADHESIVE
6 mg/d (Testosterone Transdermal System)
-- each 60 cm2 system contains 15 mg
testosterone USP
for nominal delivery of 6 mg
for one day.
Carton of 30 TESTODERMÒ
6 mg/d systems………………………….NDC 17314-4609-3
Carton of 30 TESTODERMÒ
WITH ADHESIVE 6 mg/d systems……NDC 17314-2836-3
Storage
TESTODERMâ
TTS
Store at controlled room
temperature below
25oC (77oF).
TESTODERMâ and
TESTODERMâ WITH ADHESIVE
Store at room temperature
15-30oC (59-86oF).
Disposal
TESTODERMâ
products should be discarded in household trash in a manner that
prevents accidental application or ingestion
by children or pets.
Caution: Federal law
prohibits dispensing without prescription.
REFERENCE
1. Matsumoto AM, Sandblom RE, Schoene RB et al.
Testosterone replacement in hypogonadal men: Effects on obstructive
sleep apnoea, respiratory
drives, and sleep. Clin Endocrinol (1985) 22: 713-721.
2. Schneider BK, Pickett CK, Zwillich CW et al.
Influence of testosterone
on breathing during
sleep. J Appl Physiol (1986) 61: 618-623.
3. Matsumoto AM. Hormonal therapy
of male hypogonadism.
Endocrinol Metab Clin North Am. (1994) 23: 857-875.
4. Bardin CW, Swerdloff RS, Santen RJ. Androgens:
Risks and benefits. J Clin Endocinol Metab (1991) 73: 4-7.
5. Nieschlag E, Wang CCL. Guidelines for the
use of androgens in men. Geneva: World Health Organization
(1992); 1-16.
6. Walle T, Walle UK, Mathur RS et al. Propranolol
metabolism in normal
subjects: Association with sex
steroid hormones.
Curr Pharmacol Ther (1994) 56:127-132.
7. Physicians’ Generic Rx: The Complete Drug
Reference. (1996); II-1972
top
