TAMOXIFEN CITRATE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Mylan Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

TAMOXIFEN CITRATE

Koostumus:

TAMOXIFEN 10 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Tamoxifen Citrate Tablets, USP are containing tamoxifen as the citrate equivalent to 10 mg or 20 mg of tamoxifen. The 10 mg tablets are white, unscored, round tablets debossed with M on one side of the tablet and 144 on the other side. They are available as follows: NDC 0378-0144-91 bottles of 60 tablets The 20 mg tablets are white to off-white, unscored, round tablets debossed with M on one side of the tablet and 274 on the other side. They are available as follows: NDC 0378-0274-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat (over 104°F/40°C). Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
Mylan Pharmaceuticals Inc.
----------
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 kn

Valmisteyhteenveto

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
MYLAN PHARMACEUTICALS INC.
----------
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 fo