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
Anadrol-50 Warnings, Precautions, Pregnancy, Nursing, Abuse - Oxymetholone
Anadrol-50 Warnings, Precautions, Pregnancy, Nursing, Abuse - Oxymetholone
WARNINGS
The following conditions have been reported in patients receiving
androgenic anabolic steroids as a general class
of drugs:
Peliosis hepatis, a condition
in which liver and sometimes
splenic tissue is
replaced with blood-filled cysts, has been reported in patients
receiving androgenic anabolic steroid
therapy. These cysts are sometimes present with minimal
hepatic dysfunction,
but at other times they have been associated with liver
failure. They are often not recognized until life-threatening
liver failure or intra-abdominal
hemorrhage develops.
Withdrawal of drug usually results in complete disappearance of
lesions.
Liver cell tumors are
also reported. Most often these tumors are benign and androgen-dependent,
but fatal malignant
tumors have been reported. Withdrawal of drug
often results in regression
or cessation of progression of the tumor. However, hepatic
tumors associated with androgens or anabolic steroids are much
more vascular than
other hepatic tumors
and may be silent until life-threatening intra-abdominal
hemorrhage develops.
Blood lipid changes that are known to be associated with increased
risk of atherosclerosis
are seen in patients treated with androgens and anabolic steroids.
These changes include decreased high density
lipoprotein and
sometimes increased low density
lipoprotein. The changes may be very marked and could have a serious
impact on the risk of
atherosclerosis
and coronary artery disease.
Cholestatic hepatitis
and jaundice occur
with 17-alpha-alkylated androgens at relatively low doses. Clinical
jaundice may be painless,
with or without pruritus. It may also be associated with acute
hepatic enlargement
and right upper-quadrant pain,
which has been mistaken for acute
(surgical) obstruction of the bile
duct. Drug-induced jaundice
is usually reversible when the medication
is discontinued. Continued therapy
has been associated with hepatic
coma and death. Because
of the hepatoxicity associated with oxymetholone administration,
periodic liver
function tests are
recommended.
In patients with breast
cancer, anabolic steroid
therapy may cause
hypercalcemia by stimulating osteolysis. In
this case, the drug should
be discontinued.
Edema with or without congestive heart
failure may be a serious
complication in patients with pre-existing cardiac,
renal or hepatic
disease. Concomitant administration with adrenal
steroids or ACTH may add
to the edema. This is generally controllable with appropriate
diuretic and/or digitalis
therapy.
Geriatric male patients
treated with androgenic
anabolic steroids may be at an increased risk
for the development
of prostate hypertrophy
and prostatic carcinoma.
Anabolic steroids have not been shown to enhance athletic ability.
PRECAUTIONS
General
Women should be observed for signs of virilization
(deepening of the voice, hirsutism,
acne and clitoromegaly).
To prevent irreversible
change, drug therapy
must be discontinued when mild virilism
is first detected. Such virilization
is usual following androgenic
anabolic steroid use
at high doses. Some virilizing changes in women are irreversible
even after prompt discontinuance of therapy
and are not prevented by concomitant
use of estrogens. Menstrual irregularities, including amenorrhea,
may also occur.
The insulin or oral
hypoglycemic dosage may
need adjustment
in diabetic patients who receive anabolic steroids.
Anabolic steroids may cause
suppression of clotting
factors II, V, VII and X, and an increase in prothrombin
time.
Information for the Patient
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, appearance
or aggravation of acne.
Women: Hoarseness, acne,
changes in menstrual periods or more hair
on the face.
All Patients: Any nausea,
vomiting, changes in
skin color or ankle
swelling.
Laboratory Tests
Women with disseminated
breast carcinoma
should have frequent determination of urine
and serum calcium
levels during the course of androgenic
anabolic steroid therapy
(see WARNINGS
).
Because of the hepatoxicity associated with the use of 17-alpha-alkylated
androgens, liver function
tests should be obtained periodically.
Periodic (every 6 months) x-ray examinations of bone
age should be made during
treatment of prepubertal
patients to determine the rate
of bone maturation and the effects of androgenic
anabolic steroid therapy
on the epiphyseal centers.
Anabolic steroids have been reported to lower the level of high-density
lipoproteins and raise the level of low-density lipoproteins. These
changes usually revert to normal
on discontinuation of treatment. Increased low-density lipoproteins
and decreased high-density lipoproteins are considered cardiovascular
risk factors. Serum lipids and high-density lipoprotein
cholesterol should
be determined periodically.
Hemoglobin and hematocrit
should be checked periodically for polycythemia in patients who
are receiving high doses of anabolics.
Because iron deficiency
anemia has been observed
in some patients treated with oxymetholone, periodic
determination
of the serum iron
and iron binding capacity
is recommended. If iron
deficiency is detected,
it should be appropriately treated with supplementary iron.
Oxymetholone has been shown to decrease 17-ketosteroid
excretion.
Drug Interaction
Anabolic steroids may increase sensitivity
to anticoagulants; therefore, dosage of an anticoagulant
may have to be decreased in order
to maintain the prothrombin
time at the desired therapeutic
level.
Drug/Laboratory Test Interferences
Therapy with androgenic
anabolic steroids 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 and there is no
clinical evidence
of thyroid dysfunction.
Altered tests usually persist for 2 to 3 weeks after stopping anabolic
therapy.
Anabolic steroids may cause
an increase in prothrombin
time.
Anabolic steroids have been shown to alter fasting
blood sugar
and glucose tolerance tests.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Animal data: 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.
Human data: 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 of developing prostatic
hypertrophy and
prostatic carcinoma
although conclusive evidence to support
this concept is lacking.
This compound has
not been tested for mutagenic potential. However, as noted above,
carcinogenic effects
have been attributed to treatment with androgenic
hormones. The potential
carcinogenic effects
likely occur through a hormonal mechanism
rather than by a direct chemical
interaction mechanism.
Impairment of fertility
was not tested directly in animal
species. However, as noted below under ADVERSE
REACTIONS, oligospermia in males and amenorrhea
in females are potential
adverse effects of treatment
with ANADROL® Tablets. Therefore, impairment of fertility
is a possible outcome
of treatment with
ANADROL.
Pregnancy
Pregnancy category X. See CONTRAINDICATIONS.
Nursing Mothers
It is not known whether anabolics are excreted in human
milk. Because of the potential
for serious adverse reactions in nursed infants from anabolics,
women who take oxymetholone
should not nurse.
Pediatric Use
Anabolic/androgenic steroids should be used very cautiously in
children and only by specialists who are aware of their effects
on bone maturation.
Anabolic agents may accelerate epiphyseal maturation
more rapidly than linear growth
in children, and the effect
may continue for 6 months after the drug
has been stopped. Therefore, therapy
should be monitored by x-ray studies at 6-month intervals in order
to avoid the risk of compromising
the adult height.
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