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:

Mayne Pharma Inc.

INN (International namn):

TAMOXIFEN CITRATE

Sammansättning:

TAMOXIFEN 10 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. 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 whether adjuvant tamoxifen therapy is likely to be beneficial. T

Produktsammanfattning:

Tamoxifen citrate tablets USP, 10 mg (base) are white, round, biconvex, film-coated, unscored tablets debossed "93" and "784" and are supplied in bottles of 60, 180, 500, and 1000. (NDC 51862-447-60, NDC 51862-447-18, NDC 51862-447-05, NDC 51862-447-10) Tamoxifen citrate tablets USP, 20 mg (base) are white to off-white, round, biconvex, film-coated, unscored tablets debossed "93" and "782" and are supplied in bottles of 30, 100, 500, and 1000. (NDC 51862-446-30, NDC 51862-446-01, NDC 51862-446-05, NDC 51862-446-10) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Distributed by: Mayne Pharma Greenville, NC 27834 Rev. M 7/2016

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET, FILM COATED
Mayne Pharma Inc.
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MEDICATION GUIDE
Tamoxifen (TA mox i fen) Citrate 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 kn

Produktens egenskaper

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET, FILM COATED
MAYNE PHARMA INC.
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TAMOXIFEN CITRATE TABLETS USP, 10 MG AND 20 MG (BASE)
446
447
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, USP).
Each tablet contains the following inactive ingredients:
croscarmellose sodium,