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 Side Effects, and Drug Interactions - Testosterone (transdermal)
Testoderm Side Effects, and Drug Interactions - Testosterone (transdermal)
SIDE EFFECTS
Adverse events are reported in this section
by product. Adverse events reported during use of a given product
may occur in patients who are treated with any TESTODERMâ
product.
Adverse Events with TESTODERMÒ
TTS
In clinical
studies of 457 participants (116 hypogonadal males and 341 healthy
adult males) treated for
up to 6 weeks with TESTODERMâ
TTS, the most commonly reported adverse events were application
site reactions of transient
itching (12%) and moderate or severe erythema
(3%).
Adverse events reported by less than 1% of
TESTODERMâ TTS users
in clinical trials
that were of probable or unknown relationship to drug
were:
Body as a Whole: abdominal
pain, back
pain, infection;
Cardiovascular System: congestive
heart failure, hypertension,
tachycardia;
Digestive System: diarrhea,
nausea;
Metabolic and Nutritional System:
hyperglycemia,
hyperlipemia, hyponatremia;
Musculoskeletal System: arthralgia;
Nervous System: nervousness, depression,
dizziness, dry mouth,
insomnia, decreased
libido, personality
disorder, CNS stimulation;
Respiratory System: bronchitis;
Skin System: application site
reactions--papules/pustules, edema,
vesicles, pain, other--, acne,
alopecia, hirsutism;
Urogenital System: abnormal ejaculation,
breast pain,
dysuria, urinary
tract infection,
and impaired urination.
Topical Reactions
Of 457 study participants, 3 men (1%) discontinued prematurely
because of application site
reactions.
There were no
clinically significant
differences in skin tolerability in younger (<65 years old) and
older (³ 65 years old) subjects.
A contact
sensitization
rate of 0.5% for TESTODERMâ
TTS was observed in a 6-week study of 233 normal
male volunteers.
In one study with 14 days of daily use, 42% of patients
reported 3 or more detachments of their TESTODERMâ
TTS; of these detachments, 33% occurred during exercise.
Adverse Events with TESTODERMâ
In clinical studies
of 104 patients treated with TESTODERMâ
, the most common adverse effects reported were local
effects. In US clinical trials,
most of the 72 patients filling
out a daily questionnaire
reported scrotal itching, discomfort, or irritation
at some time during therapy.
Of all the daily questionnaire
responses, 7% reported itching, 4% discomfort, and 2% irritation.
All topical reactions
decreased with duration
of use.
The following adverse effects (greater than 1%) were
reported in association
with TESTODERMâ therapy
in 104 patients using the product
for up to three years. These effects are listed in decreasing frequency
of occurrence with the percentages of patients reporting the effect
in parentheses: Gynecomastia (5%), acne (4%), prostatitis/urinary
tract infection
(4%), breast tenderness
(3%), stroke (2%). For this same patient
population, the following adverse effects were reported by 1% of
users: memory loss, pupillary
dilation, abnormal
liver enzymes, scrotal cellulitis,
deep vein
phlebitis, benign
prostatic hyperplasia, rectal
mucosal lesion over prostate,
hematuria/bladder cancer, papilloma on scrotum, and congestive heart
failure.
See CLINICAL
PHARMACOLOGY, Clinical Studies, regarding
effects on serum lipids.
Adverse Events with TESTODERMâ
WITH ADHESIVE
In a pharmacokinetic study in 50 normal
men, skin assessment scores following a single 24-hour application
of TESTODERMâ WITH ADHESIVE
to scrotal skin were similar
to those for TESTODERMâ
. Other adverse events reported during the study were headache
(6%), dizziness (6%), back
pain, pain, nausea,
and pustular rash
(1% each).
General Adverse Events with Androgen Replacement
Therapy
Skin and Appendages: Hirsutism,
male pattern
baldness, seborrhea, and acne.
Endocrine and Urogenital: Gynecomastia and excessive
frequency and duration
of penile erections.
Oligospermia may occur at high doses (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
The TESTODERMâ
products contain a Schedule III controlled substance
as defined by the Anabolic Steroids Control Act.
TESTODERMâ
TTS is designed for application to arm, back
or upper buttocks skin.
TESTODERMâ
and TESTODERMâ WITH
ADHESIVE are designed for application to scrotal skin
only. Because scrotal skin is at least five times more permeable
to testosterone
than other skin sites,
TESTODERMâ or TESTODERMâ
WITH ADHESIVE will not
produce adequate serum
testosterone concentrations
if applied to non-scrotal skin.
Ingestion of testosterone, or the contents of any
of the TESTODERMâ products
will not result in clinically
significant serum
testosterone concentrations
due to extensive first-pass metabolism. In
addition, an intramuscular
injection of testosterone
from any of the TESTODERMâ
products will not produce
adequate serum testosterone
levels due to its short half-life
(about 10 minutes).
DRUG INTERACTIONS
Drug Interactions
Anticoagulants: C-17 substituted
derivatives of testosterone, such
as methandrostenolone, have been reported to decrease the anticoagulant
requirements of patients receiving oral
anticoagulants. Patients receiving oral
anticoagulant
therapy 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 and
therefore, insulin requirements.
Propranolol: In a published pharmacokinetic
study of an injectable
testosterone product,
administration
of testosterone cypionate led to an increased clearance
of propranolol in the majority of men tested.6
Corticosteroids: The concurrent administration
of testosterone
with ACTH or corticosteroids
may enhance edema formation;
thus these drugs should be administered cautiously, particularly
in patients with cardiac
or hepatic disease.7
Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxin-binding 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.
DRUG ABUSE AND DEPENDENCE
The TESTODERMâ
products contain a Schedule III controlled substance
as defined by the Anabolic Steroids Control Act.
TESTODERMâ
TTS is designed for application to arm, back
or upper buttocks skin.
TESTODERMâ
and TESTODERMâ WITH
ADHESIVE are designed for application to scrotal skin
only. Because scrotal skin is at least five times more permeable
to testosterone
than other skin sites,
TESTODERMâ or TESTODERMâ
WITH ADHESIVE will not
produce adequate serum
testosterone concentrations
if applied to non-scrotal skin.
Ingestion of testosterone, or the contents of any
of the TESTODERMâ products
will not result in clinically
significant serum
testosterone concentrations
due to extensive first-pass metabolism. In
addition, an intramuscular
injection of testosterone
from any of the TESTODERMâ
products will not produce
adequate serum testosterone
levels due to its short half-life
(about 10 minutes).
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