TAMOXIFEN CITRATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Bryant Ranch Prepack

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are 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 citrate tablet therapy. Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in postmenopausal 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 whether adjuvant

Rezumat produs:

Product: 71335-0893 NDC: 71335-0893-1 30 TABLET in a BOTTLE NDC: 71335-0893-2 60 TABLET in a BOTTLE NDC: 71335-0893-3 90 TABLET in a BOTTLE NDC: 71335-0893-4 28 TABLET in a BOTTLE NDC: 71335-0893-5 58 TABLET in a BOTTLE NDC: 71335-0893-6 52 TABLET in a BOTTLE

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
Bryant Ranch Prepack
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MEDICATION GUIDE
TAMOXIFEN CITRATE TABLETS, USP
(ta mox' i fen sit' rate)
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 abo

Caracteristicilor produsului

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
BRYANT RANCH PREPACK
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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 vs. 0.25
for placebo**.
Some of the strokes, pulmonary emboli, and uterine malignancies were
fatal.
Healthcare providers should discuss the potential benefits vs. 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 CLINICAL PHARMACOLOGY: Clinical Studies: Table 3.
DESCRIPTION
Tamoxifen Citrate Tablets USP, a nonsteroidal antiestrogen, are for
oral administration. Tamoxifen
citrate tablets are available as:
10 MG TABLETS. Each tablet contains 15.2 mg of tamoxifen citrate which
is equivalent to 10 mg of
tamoxifen.
20 MG TABLETS. Each tablet contains 30.4 mg of tamoxifen citrate which
is equivalent to 20 mg of
tamoxifen.
Each tablet contains the followin