OVERDOSE
Long-term clinical trials have been conducted with dosages
up to 200 mg of CASODEX daily and these dosages have been
well tolerated. A single dose of CASODEX that results
in symptoms of an overdose considered to be life-threatening
has not been established.
There is no specific antidote; treatment of an overdose
should be symptomatic.
In the management of an overdose with CASODEX, vomiting
may be induced if the patient is alert. It should be remembered
that, in this patient population, multiple drugs may have
been taken. Dialysis is not likely to be helpful since
CASODEX is highly protein bound and is extensively metabolized.
General supportive care, including frequent monitoring
of vital signs and close observation of the patient, is
indicated.
CONTRAINDICATIONS
CASODEX is contraindicated in any patient who has shown
a hypersensitivity reaction to the drug or any of the
tablet’s components.
CASODEX is not indicated in women. Further, CASODEX is
contraindicated in women who are or may become pregnant.
If this drug is used during pregnancy, or if the patient
becomes pregnant while taking this drug, the patient should
be apprised of the potential hazard to the fetus. CASODEX
may cause fetal harm when administered to pregnant women.
The male offspring of rats receiving doses of 10mg/kg/day
(plasma drug concentrations in rats equal to approximately
2/3 human therapeutic concentrations*) and above were
observed to have reduced anogenital distance and hypospadias
in reproductive toxicology studies. These pharmacological
effects have been observed with other antiandrogens. No
other teratogenic effects were observed in rabbits receiving
doses up to 200mg/kg/day (approximately 1/3 human therapeutic
concentrations*) or rats receiving doses up to 250 mg/kg/day
(approximately 2 times human therapeutic concentrations*).
*Based on a maximum dose of 50 mg/day of bicalutamide
for an average 70 kg patient.
| |
