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
Teslac Warnings, Precautions, Pregnancy, Nursing, Abuse - Testolactone
Teslac Warnings, Precautions, Pregnancy, Nursing, Abuse - Testolactone
WARNINGS
No Information Provided.
PRECAUTIONS
Information for Patients: The physician should be consulted
regarding missed doses. Notify the physician if adverse reactions occur or become
more pronounced.
Laboratory Tests: Plasma calcium levels should be routinely
determined in any patient receiving therapy for mammary cancer, particularly
during periods of active remission of bony metastases. If hypercalcemia occurs,
appropriate measures should be instituted.
Drug Interactions: When administered concurrently, testolactone
may increase the effects of oral anticoagulants; monitor and adjust anticoagulant
dosage accordingly.
Drug/Laboratory Test Interactions: Physiologic effects of
testolactone may result in decreased estradiol concentrations with radioimmunoassays
for estradiol, increased plasma calcium concentrations (see PRECAUTIONS
,
Laboratory Tests section), and increased 24-hour urinary excretion of
creatine and 17-ketosteroids.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No
long-term animal studies have been performed to evaluate carcinogenic potential
or mutagenesis. Testolactone did not affect fertility in male or female rats.
Pregnancy: Teratogenic Effects, "Category C": In rats, testolactone
has been shown to produce increased fetal mortality, increased abnormal fetal
development, and increased mortality in growing pups when given at doses 5 to
15 times the recommended human dose. In rabbits, no teratologic effects were
observed at doses 2.5 to 7.5 times the recommended human dose. There are no
adequate and well controlled studies in pregnant women. Testolactone is intended
for use only in postmenopausal women and should not be used during pregnancy.
Nursing Mothers: It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human milk, a decision should
be made whether or not to discontinue nursing.
Pediatric Use: Safety and effectiveness in children have
not been established.
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