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
Cenestin Online, Description, Chemistry, Ingredients - Synthetic conjugated estrogens
Cenestin Online, Description, Chemistry, Ingredients - Synthetic conjugated estrogens
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ESTROGENS INCREASE THE RISK OF ENDOMETRIAL
CANCER
Close clinical surveillance of all women taking estrogens
is important. Adequate diagnostic measures, including endometrial sampling
when indicated, should be undertaken to rule out malignancy in all cases
of undiagnosed persistent or recurring abnormal vaginal bleeding. There
is no evidence that the use of "natural" estrogens results in
a different endometrial risk profile than synthetic estrogens at equivalent
estrogen doses. (See WARNINGS, Malignant
neoplasms, Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used
for the prevention of cardiovascular disease. (See WARNINGS,
Cardiovascular disorders.)
The Women's Health Initiative (WHI) study reported increased
risks of myocardial infarction, stroke, invasive breast cancer, pulmonary
emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years
of age) during 5 years of treatment with oral conjugated equine estrogens
(CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative
to placebo. (See CLINICAL PHARMACOLOGY,
Clinical Studies.)
Other doses of oral conjugated estrogens with medroxyprogesterone,
and other combinations and dosage forms of estrogens and progestins were
not studied in the WHI clinical trials and, in the absence of comparable
data, these risks should be assumed to be similar. Because of these risks,
estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment
goals and risks for the individual woman.
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DESCRIPTION
Synthetic conjugated estrogens, A tablets contain a blend of
nine (9) synthetic estrogenic substances. The estrogenic substances are sodium
estrone sulfate, sodium equilin sulfate, sodium 17a-dihydroequilin
sulfate, sodium 17a-estradiol sulfate, sodium 17b-dihydroequilin
sulfate, sodium 17a-dihydroequilenin sulfate, sodium
17b-dihydroequilenin sulfate, sodium equilenin sulfate
and sodium 17b-estradiol sulfate.
Tablets for oral administration, are available in 0.3 mg, 0.45mg,
0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, A.
Tablets also contain the following inactive ingredients: ethylcellulose, hypromellose,
lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80,
pregelatinized starch, titanium dioxide, and triethyl citrate.
-0.3 mg tablets also contain: FD&C Blue No. 2 aluminum
lake and D&C Yellow No. 10 aluminum lake.
-0.45 mg tablets also contain FD&C Yellow No. 6/Sunset
Yellow FCF lake.
-0.625 mg tablets also contain: FD&C Red No. 40 aluminum
lake.
-0.9 mg tablets do not contain additional color additives.
-1.25 mg tablets also contain FD&C Blue No. 2 aluminum
lake.
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