TAMOXIFEN CITRATE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Bryant Ranch Prepack

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Metastatic Breast Cancer Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. Adjuvant Treatment of Breast Cancer Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whe

Produktsammanfattning:

NDC: 71335-1424-1: 30 Tablets in a BOTTLE NDC: 71335-1424-2: 60 Tablets in a BOTTLE NDC: 71335-1424-3: 90 Tablets in a BOTTLE NDC: 71335-1424-4: 28 Tablets in a BOTTLE NDC: 71335-1424-5: 58 Tablets in a BOTTLE NDC: 71335-1424-6: 52 Tablets in a BOTTLE

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Bryant Ranch Prepack
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MEDICATION GUIDE
Tamoxifen Citrate (ta mox' i fen si' trate) Tablets, USP
Rx only
Written for women who use tamoxifen citrate tablets to lower their
high chance of getting breast cancer or
who have ductal carcinoma in situ (DCIS)
This Medication Guide discusses only the use of tamoxifen citrate
tablets to lower the chance of getting
breast cancer in high-risk women and in women treated for DCIS.
People taking tamoxifen citrate tablets to treat breast cancer have
different benefits and different decisions to
make than high-risk women or women with ductal carcinoma in situ
(DCIS) taking tamoxifen citrate tablets
to reduce the chance of getting breast cancer. If you already have
breast cancer, talk with your doctor about
how the benefits of treating breast cancer with tamoxifen citrate
tablets compare to the risks that are
described in this document.
Why should I read this Medication Guide?
This guide has information to help you decide whether to use tamoxifen
citrate tablets to lower your chance
of getting breast cancer. You and your doctor should talk about
whether the possible benefit of tamoxifen
citrate tablets in lowering your high chance of getting breast cancer
is greater than its possible risks. Your
doctor has a special computer program or hand-held calculator to tell
if you are in the high-risk group. If you
have DCIS and have been treated with surgery and radiation therapy,
your doctor may prescribe tamoxifen
citrate tablets to decrease your chance of getting invasive
(spreading) breast cancer.
Read this guide carefully before you start tamoxifen citrate tablets.
It is important to read the information you
get each time you get more medicine. There may be something new. This
guide does not tell you everything
about tamoxifen citrate tablets and does not take the place of talking
with your doctor.
Only you and your doctor can determine if tamoxifen citrate tablets
are right for you.
What is the most important information I should know about using
tamoxifen citrate tablets t

Produktens egenskaper

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET, FILM COATED
BRYANT RANCH PREPACK
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TAMOXIFEN CITRATE TABLETS, USP
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 CITRATE
TABLETS 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 CITRATE TABLETS VS. 0.4 FOR PLACEBO)*. FOR STROKE, THE
INCIDENCE
RATE PER 1,000 WOMEN-YEARS WAS 1.43 FOR TAMOXIFEN CITRATE TABLETS VS.
1.00 FOR PLACEBO**. FOR PULMONARY EMBOLISM, THE INCIDENCE RATE PER
1,000 WOMEN-YEARS WAS 0.75 FOR TAMOXIFEN CITRATE TABLETS 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 CITRATE
TABLETS TO REDUCE THEIR RISK OF DEVELOPING BREAST CANCER. THE BENEFITS
OF
TAMOXIFEN CITRATE TABLETS 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 film coated tablet contains tamoxifen citrate15.2 mg or 30.4 mg
equivalent to
tamoxifen 10 mg or 20 mg respectively.
Each tablet contain