TAMOXIFEN CITRATE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Aurobindo Pharma Limited

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 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 tablets 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 citrate 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 progester

Proizvod sažetak:

Tamoxifen Citrate Tablets, USP 10 mg contains 15.2 mg of tamoxifen citrate equivalent to 10 mg of tamoxifen. The tablets are white to off-white, round, biconvex, film-coated, unscored tablets debossed with T10 on one side and plain on the other side.                  Bottles of 60               NDC 59651-299-60 Tamoxifen Citrate Tablets, USP 20 mg contains 30.4 mg of tamoxifen citrate equivalent to 20 mg of tamoxifen. The tablets are white to off-white, round, biconvex, film-coated, unscored tablets debossed with T20 on one side and plain on the other side.                  Bottles of 30               NDC 59651-300-30                  Bottles of 90               NDC 59651-300-90 Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Dispense in a well-closed, light-resistant container. The brands listed are the trademarks of their respective owners and are not trademarks of the Aurobindo Pharma Limited. Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Medchal-Malkajgiri District- 500101 India Issued: August 2019

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

TAMOXIFEN CITRATE - TAMOXIFEN CITRATE TABLET, FILM COATED
Aurobindo Pharma Limited
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MEDICATION GUIDE
Tamoxifen Citrate Tablets, USP
(ta mox’ i fen si’ trate)
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 informa

Svojstava lijeka

TAMOXIFEN CITRATE - TAMOXIFEN CITRATE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
TAMOXIFEN CITRATE TABLETS, USP
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 citrate 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 citrate
vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000
women-years of 0.17 for
tamoxifen citrate vs 0.4 for placebo)*. For stroke, the incidence rate
per 1,000 women-years was
1.43 for tamoxifen citrate vs 1.00 for placebo**. For pulmonary
embolism, the incidence rate per
1,000 women-years was 0.75 for tamoxifen citrate 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 to reduce their risk of developing breast cancer.
The benefits of tamoxifen citrate 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. Tamoxifen
citrate tablets are available as:
10 MG TABLETS:
Each tablet contains 15.2 mg of tamoxifen citrate USP equivalent to 10
mg of tamoxifen.
20 MG TABLETS:
Each t