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Rx Item-Tamoxifen 10Mg Tab 60 By Actavis Pharma

NDC 00591-2472-60 UPC/GTIN No.3-05912-47260-1 Mfg.Part No.247260BRAND: TAMOXIFEN NDC: 00591-2472-60,591247260 UPC: 3-05912-47260-1,305912472601 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Tamoxifen 10Mg Tab 60 By Actavis Pharma

$113.64$14.10

Item No.: RX182271 NDC No.591247260 UPC No.:305912472601 NDC No. 00591-2472-60 UPC/GTIN No. 3-05912-47260-1 MPN 247260 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx182271 Tamoxifen 10mg Tab 60 by Actavis Pharma Item No. 3182271 NDC No. 00591247260 UPC No. 305912472601 Other Name Tamoxifen Th

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TAMOXIFEN CITRATE- tamoxifen citrate tablet, film coated
Mayne Pharma 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 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.
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, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide.

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- propanetricarboxylate (1:1).
C32 H37 NO8 M.W. 563.62

Tamoxifen citrate has a pKa� of 8.85, the equilibrium solubility in water at 37�C is 0.5 mg/mL and in 0.02 N HCl at 37�C, it is 0.2 mg/mL.

CLINICAL PHARMACOLOGY

Tamoxifen citrate is a nonsteroidal agent that has demonstrated potent antiestrogenic properties in animal test systems. The antiestrogenic effects may be related to its ability to compete with estrogen for binding sites in target tissues such as breast. Tamoxifen inhibits the induction of rat mammary carcinoma induced by dimethylbenzanthracene (DMBA) and causes the regression of already established DMBA-induced tumors. In this rat model, tamoxifen appears to exert its antitumor effects by binding the estrogen receptors.

In cytosols derived from human breast adenocarcinomas, tamoxifen competes with estradiol for estrogen receptor protein.
DOSAGE AND ADMINISTRATION

For patients with breast cancer, the recommended daily dose is 20 to 40 mg. Dosages greater than 20 mg per day should be given in divided doses (morning and evening).

In three single agent adjuvant studies in women, one 10 mg tamoxifen citrate tablet was administered two (ECOG and NATO) or three (Toronto) times a day for two years. In the NSABP B-14 adjuvant study in women with node-negative breast cancer, one 10 mg tamoxifen citrate tablet was given twice a day for at least 5 years. Results of the B-14 study suggest that continuation of therapy beyond five years does not provide additional benefit (see CLINICAL PHARMACOLOGY). In the EBCTCG 1995 overview, the reduction in recurrence and mortality was greater in those studies that used tamoxifen for about 5 years than in those that used tamoxifen for a shorter period of therapy. There was no indication that doses greater than 20 mg per day were more effective. Current data from clinical trials support 5 years of adjuvant tamoxifen therapy for patients with breast cancer.

Ductal Carcinoma in Situ (DCIS)
The recommended dose is tamoxifen 20 mg daily for 5 years.

Reduction in Breast Cancer Incidence in High Risk Women
The recommended dose is tamoxifen 20 mg daily for 5 years. There are no data to support the use of tamoxifen other than for 5 years (see CLINICAL PHARMACOLOGY , Clinical Studies , Reduction in Breast Cancer Incidence in High Risk Women ).

NDC 00591-2472-60 UPC/GTIN No.3-05912-47260-1 Mfg.Part No.247260
RX ITEM-Tamoxifen 10Mg Tab 60 By Actavis
NDC 00591-2472-60 UPC/GTIN No.3-05912-47260-1 Mfg.Part No.247260

BRAND: TAMOXIFEN NDC: 00591-2472-60,591247260 UPC: 3-05912-47260-1,305912472601
Tamoxifen 10Mg Tab 60 By Actavis Pharma
BRAND: TAMOXIFEN NDC: 00591-2472-60,591247260 UPC: 3-05912-47260-1,305912472601

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for TAMOXIFEN
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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