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 Side Effects, and Drug Interactions - Testosterone Transdermal System
Androderm Side Effects, and Drug Interactions - Testosterone Transdermal System
Adverse Events Associated with Androderm (testosterone transdermal
system)
In clinical studies of 122
patients treated with Androderm, the most common adverse events reported
were skin reactions at the site
of system application. Transient mild to moderate erythema
was observed at the site of application in the majority of patients at
some time during treatment.
The adverse reactions reported by more than 1% of patients are listed
below shown in order of decreasing
frequency.
| Event
|
Percent of Patients
|
| pruritus
at application site |
37%
|
| burn-
like blister reaction
under system
|
12%
|
| erythema
at application site |
7%
|
| vesicles
at application site |
6%
|
| prostate
abnormalities |
5%
|
| headache
|
4%
|
| allergic
contact dermatitis
to the system
|
4%
|
| burning
at application site |
3%
|
| induration
at application site |
30%
|
| depression
|
3 %
|
| rash
|
2%
|
| gastrointestinal
bleeding |
2%
|
The following reactions occurred in less than 1% of patients: Fatigue;
body pain; pelvic pain; hypertension;
peripheral vascular
disease; increased appetite; accelerated growth; anxiety; confusion; decreased
libido; paresthesia; thinking abnormalities; vertigo; acne; bullae at
application site; mechanical irritation at application site; rash
at application site; contamination of application site; prostate
carcinoma; dysuria; hematuria; impotence; urinary incontinence; urinary
tract infection; testicular
abnormalities.
Three types of application site
reactions occurred: irritation
which included mild to moderate erythema. induration
or burning; allergic contact
dermatitis; and burn-like blister
reactions.
Chronic skin irritation
caused 5% of patients to discontinue treatment. Mild skin
irritation may be ameliorated
by treatment of affected
skin with over-the-counter topical
hydrocortisone cream
or topical antihistamine products.
Five patients (4%) developed allergic
contact dermatitis
after 3 to 6 weeks treatment
that required discontinuation. These reactions were characterized by pruritus,
erythema, induration
and in some instances vesicles or bullae, which recurred with each system
application. Rechallenge with components of the system
showed ethanol sensitization
in 4 patients. One patient’s reaction was attributed to testosterone.
None of these patients had adverse sequelae related to oral
alcohol ingestion
or to injectable testosterone
use. Older patients may be more, prone
to develop allergic contact
dermatitis.
Fourteen patients (12%) had burn-like blister
reactions that involved bullae, epidermal necrosis
or the development of
ulcerated lesions. These
reactions typically occurred once, at a single application site; 5 patients
experienced a single recurrence. None withdrew from the clinical
trials. These reactions occurred at a rate
of approximately 1 ,in 6,500 system applications (1 in 3,250 treatment
days). The majority of these lesions were associated with system
application over bony prominences
or on parts of the b.d. that
may have been subject to prolonged
pressure during sleep or
sitting (e.g., over the deltoid
region of the upper arm, the
greater trochanter of the femur, or the ischial
tuberosity). The more severe lesions healed over several weeks with scarring
in some cases. Such lesions should be treated as burns.
Adverse Events Associated with Injection or Oral Treatments
Skin and Appendages: Hirsutism, male
pattern of baldness, seborrhea,
and acne.
Endocrine and Urogenital: Gynecomastia and excessive frequency
and duration of penile
erections. Oligospermia may occur at high dosages (see CLINICAL
PHARMACOLOGY).
Fluid and Electrolyte Disturbances: Retention of sodium,
chloride, water, potassium,
calcium, and inorganic
phosphates.
Gastrointestinal: Nausea, cholestatic jaundice,
alterations in liver function
tests. Rare instances of hepatocellular
neoplasms and peliosis hepatis have occurred (see WARNINGS).
Hematologic: Suppression of clotting
factors II, V, VII, and X; bleeding
in patients on concomitant
anticoagulant therapy
and polycythemia.
Nervous System: Increased or decreased libido,
headache, anxiety, depression
and generalized paresthesia.
Metabolic: Increased serum
cholesterol.
Miscellaneous: Rarely, anaphylactoid reactions.
DRUG ABUSE AND DEPENDENCE
Androderm (testosterone transdermal system) is a Schedule III controlled
substance under the Anabolic Steroids Control Act. Oral consumption
of the Androderm system or
the gel contents of the system
will not result in clinically
significant serum
testosterone concentrations
in the target organs due to extensive first-pass metabolism.
DRUG INTERACTIONS
Anticoagulants: C-l 7 substituted derivatives of testosterone,
such as methandrostenolone. have been reported to decrease the anticoagulant
requirements of patients receiving oral
anticoagulants. Patients receiving oral anticoagulants require close monitoring
especially when androgens are started or stopped.
Oxyphenbutazone: Concurrent administration
of oxyphenbutazone and androgens may result in elevated serum
levels of oxyphenbutazone.
Insulin: In diabetic
patients, the metabolic effects of androgens may decrease blood
glucose a.d.
therefore, insulin requirements.
Drug/Laboratory Test Interferences
Androgens may decrease levels of thyroxinebinding globulin, resulting
in decreased total T4 serum
levels and increased resin uptake
of T3 and T4. Free thyroid
hormone levels remain unchanged,
however, and there is no clinical
evidence of thyroid
dysfunction.
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