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 Indications, Dosage, Storage, Stability - Testolactone
Teslac Indications, Dosage, Storage, Stability - Testolactone
INDICATIONS
AND USES
TESLAC (testolactone tablets, USP) is recommended as adjunctive therapy in
the palliative treatment of advanced or disseminated breast cancer in postmenopausal
women when hormonal therapy is indicated. It may also be used in women who were
diagnosed as having had disseminated breast carcinoma when premenopausal, in
whom ovarian function has been subsequently terminated.
TESLAC was found to be effective in approximately 15 percent of patients with
advanced or disseminated mammary cancer evaluated according to the following
criteria: 1) those with a measurable decrease in size of all demonstrable tumor
masses; 2) those in whom more than 50 percent of non-osseous lesions decreased
in size although all bone lesions remained static; and 3) those in whom more
than 50 percent of total lesions improved while the remainder were static.
DOSAGE AND ADMINISTRATION
The recommended oral dose is 250 mg qid.
In order to evaluate the response, therapy with testolactone should be continued
for a minimum of three months unless there is active progression of the disease.
HOW SUPPLIED
TESLAC® (testolactone tablets, USP)
50 mg/tablet: bottles of 100 ( NDC 0003-0690-50). Each round, white,
biconvex tablet is imprinted with the identification number 690.
Storage
Store at controlled room temperature 25°C (77°F).
Mead Johnson
ONCOLOGY PRODUCTS
A Bristol-Myers Squibb Company
Princeton, NJ 08543
U.S.A.
Made in Australia
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