TAMOXIFEN CITRATE tablet film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)

Dostępny od:

KAISER FOUNDATION HOSPITALS

INN (International Nazwa):

TAMOXIFEN CITRATE

Skład:

TAMOXIFEN 10 mg

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
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TAMOXIFEN CITRATE TABLETS USP, 10 MG AND 20 MG (BASE)
RX ONLY
WARNING
For Women With Ductal Carcinoma in Situ (DCIS) and Women at High Risk
for Breast Cancer
Serious and life-threatening events associated with tamoxifen in the
risk reduction setting (women
at high risk for cancer and women with DCIS) include uterine
malignancies, stroke and pulmonary
embolism. Incidence rates for these events were estimated from the
NSABP P-1 trial (see
CLINICAL PHARMACOLOGY, CLINICAL STUDIES, _REDUCTION IN BREAST CANCER
INCIDENCE IN_
_HIGH RISK WOMEN_). UTERINE MALIGNANCIES CONSIST OF BOTH ENDOMETRIAL
ADENOCARCINOMA
(INCIDENCE RATE PER 1,000 WOMEN-YEARS OF 2.20 FOR TAMOXIFEN VS. 0.71
FOR PLACEBO) AND
UTERINE SARCOMA (INCIDENCE RATE PER 1,000 WOMEN-YEARS OF 0.17 FOR
TAMOXIFEN VS. 0.4 FOR
PLACEBO)
. FOR STROKE, THE INCIDENCE RATE PER 1,000 WOMEN-YEARS WAS 1.43 FOR
TAMOXIFEN VS.
1.00 FOR PLACEBO
. FOR PULMONARY EMBOLISM, THE INCIDENCE RATE PER 1,000 WOMEN-YEARS
WAS 0.75 FOR TAMOXIFEN VERSUS 0.25 FOR PLACEBO
.
Some of the strokes, pulmonary emboli, and uterine malignancies were
fatal.
Health care providers should discuss the potential benefits versus the
potential risks of these
serious events with women at high risk of breast cancer and women with
DCIS considering
tamoxifen to reduce their risk of developing breast cancer.
The benefits of tamoxifen outweigh its risks in women already
diagnosed with breast cancer.
Updated long-term follow-up data (median length of follow-up is 6.9
years) from NSABP P-1
study. See WARNINGS, EFFECTS ON THE UTERUS-ENDOMETRIAL CANCER AND
UTERINE SARCOMA.
See TABLE 3 under CLINICAL PHARMACOLOGY, CLINICAL STUDIES.
DESCRIPTION
Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for
oral administration. Each tablet
contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg,
respectively, of tamoxifen
citrate).
Each tablet contains the following inactive ingredients:
croscarmellose sodium, hyp