Cas No 315-37-7
Women should be observed for signs
of virilization (deepening of the voice, hirsutism, acne,
clitoromegaly, and menstrual irregularities). Discontinuation of
drug therapy at the time of evidence of mild virilism is necessary
to prevent irreversible virilization. Such virilization is usual
following androgen use at high doses and is not prevented by
concomitant use of estrogens. A decision may be made by the patient
and the physician that some virilization will be tolerated during
treatment for breast carcinoma.
Because androgens may alter serum
cholesterol concentration, caution should be used when administering
these drugs to patients with a history of myocardial infarction or
coronary artery disease. Serial determinations of serum cholesterol
should be made and therapy adjusted accordingly. A causal
relationship between myocardial infarction and hypercholesterolemia
has not been established.
Information for Patients
Male adolescent patients receiving
androgens for delayed puberty should have bone development checked
every six months.
The physician should instruct
patients to report any of the following side effects of androgens:
Adult or adolescent males - too
frequent or persistent erections of the penis.
Women - hoarseness, acne, changes
in menstrual periods, or more facial hair.
All patients - any nausea,
vomiting, changes in skin color, or ankle swelling.
Clinical studies of Testosterone
Enanthate injection, USP did not include sufficient numbers of
subjects, aged 65 and older, to determine whether they respond
differently from younger subjects. Testosterone replacement is not
indicated in geriatric patients who have age-related hypogonadism
only ("andropause"), because there is insufficient safety and
efficacy information to support such use. Current studies do not
assess whether testosterone use increases risks of prostate cancer,
prostate hyperplasia, and cardiovascular disease in the geriatric
Women with disseminated breast
carcinoma should have frequent determination of urine and serum
calcium levels during the course of androgen therapy.
Periodic (every six months) X-ray
examinations of bone age should be made during treatment of
prepubertal males to determine the rate of bone maturation and the
effects of androgen therapy on the epiphyseal centers.
Hemoglobin and hematocrit should
be checked periodically for polycythemia in patients who are
receiving high doses of androgens.
When administered concurrently, the
following drugs may interact with androgens:
Anticoagulants, oral - C-17
substituted derivatives of testosterone, such as methandrostenolone,
have been reported to decrease the anticoagulant requirement.
Patients receiving oral anticoagulant therapy require close
monitoring especially when androgens are started or stopped.
Antidiabetic drugs and insulin -
In diabetic patients, the metabolic effects of androgens may
decrease blood glucose and insulin requirements.
ACTH and corticosteroids -
Enhanced tendency toward edema. Use caution when giving these drugs
together, especially in patients with hepatic or cardiac disease.
Oxphenbutazone - Elevated serum
levels of oxyphenbutazone may result.
Androgens may decrease levels of
thyroxine-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
Testosterone has been tested by
subcutaneous injection and implantation in mice and rats. The
implant induced cervical-uterine tumors in mice, which metastasized
in some cases. There is suggestive evidence that injection of
testosterone into some strains of female mice increases their
susceptibility to hepatoma. Testosterone is also known to increase
the number of tumors and decrease the degree of differentiation of
chemically induced carcinomas of the liver in rats.
There are rare reports of
hepatocellular carcinoma in patients receiving long-term therapy
with androgens in high doses. Withdrawal of the drugs did not lead
to regression of the tumors in all cases.
Geriatric patients treated with
androgens may be at an increased risk for the development of
prostatic hypertrophy and prostatic carcinoma.
It is not known whether androgens
are excreted in human milk. Because many drugs are excreted in human
milk and because of the potential for serious adverse reactions in
nursing infants from androgens, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account
the importance of the drug to the mother.
Androgen therapy should be used
very cautiously in pediatric patients and only by specialists who
are aware of the adverse effects on bone maturation. Skeletal
maturation must be monitored every six months by an X-ray of the
hand and wrist