TAMOXIFEN CITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

TAMOXIFEN CITRATE

Composition:

TAMOXIFEN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tamoxifen citrate tablets, USP 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, USP 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, USP 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 b

Product summary:

Tamoxifen Citrate Tablets, USP are available as: 20 mg: Containing 30.4 mg tamoxifen citrate, an amount equivalent to 20 mg of tamoxifen. White, round, unscored, biconvex tablet. Debossed with "2233" on one side and "WPI" on the other side. Available in bottles of: Unit-of-use 30 Tablets NDC 63187-976-30 Unit-of-use 60 Tablets NDC 63187-976-60 Unit-of-use 90 Tablets NDC 63187-976-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed, light-resistant container. For more information about tamoxifen citrate, call 1-800-272-5525. Arimidex® is a trademark of AstraZeneca.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
Proficient Rx LP
----------
MEDICATION GUIDE
Tamoxifen Citrate Tablets, USP
(ta-MOX-I-fen)
Written for women who use tamoxifen 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 to lower the
chance of getting breast cancer in
high-risk women and in women treated for DCIS.
People taking tamoxifen 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 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 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
to lower your chance of getting
breast cancer.
You and your doctor should talk about whether the possible benefit of
tamoxifen 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 to
decrease your chance of getting
invasive (spreading) breast cancer.
Read this guide carefully before you start tamoxifen. 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 and does not take the place of talking with your doctor.
Only you and your doctor can determine if tamoxifen is right for you.
What is the most important information I should know about using
tamoxifen to reduce the chance of getting
breast cancer?
Tamoxifen is a prescription medicine that is like estrogen (female
hormone) in some ways and different in
other ways. In the b

Summary of Product characteristics

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET
PROFICIENT RX LP
----------
TAMOXIFEN CITRATE TABS
TAMOXIFEN CITRATE TABLETS, USP
REVISED: APRIL 2015
196201-2
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 1000 WOMEN-YEARS OF
2.20 FOR TAMOXIFEN VS. 0.71 FOR PLACEBO) AND UTERINE SARCOMA
(INCIDENCE
RATE PER 1000 WOMEN-YEARS OF 0.17 FOR TAMOXIFEN VS. 0.4 FOR PLACEBO)*.
FOR STROKE, THE INCIDENCE RATE PER 1000 WOMEN-YEARS WAS 1.43 FOR
TAMOXIFEN VS. 1.00 FOR PLACEBO**. FOR PULMONARY EMBOLISM, THE
INCIDENCE
RATE PER 1000 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 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.
Chemically, tamoxifen is the trans-isomer of a triphenylethylene
derivative. The chemical
name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N,
N-dimethylethanamine 2 hydroxy-
1,2,3- pro