Tamoxifen Citrate 10 mg/1
Tamoxifen Citrate · TABLET, FILM COATED · Dr. Reddy's Labratories Inc.
Tamoxifen Citrate is a tablet, film coated containing tamoxifen citrate at 10 mg/1, taken oral. Manufactured by Dr. Reddy's Labratories Inc..
Key Facts
- Brand Name
- Tamoxifen Citrate
- Generic Name
- Tamoxifen Citrate
- NDC Code (Product)
75907-058- Manufacturer
- Dr. Reddy's Labratories Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075797
- Marketing Start
- 08/22/2024
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial. Tamoxifen citrate tablets reduces …
Dosage & Administration
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 citrate therapy for patients with breast cancer. Ductal Carcinoma in Situ (DCIS): The recommended dose is tamoxifen citrate 20 mg daily for 5 years. Reduction in Breast Cancer In…
Warnings
WARNINGS Effects in Metastatic Breast Cancer Patients: As with other additive hormonal therapy (estrogens and androgens), hypercalcemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with tamoxifen citrate. If hypercalcemia does occur, appropriate measures should be taken and, if severe, tamoxifen citrate should be discontinued. Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma: An increased incidence of uterine malignancies has been reported in association with tamoxifen citrate treatment. The underlying mechanism is unknown, but may be related to the estrogen-like effect of tamoxifen citrate. Most uterine malignancies seen in association with tamoxifen citrate are classified as adenocarcinoma of the endometrium. However, rare uterine sarcomas, including malignant mixed mullerian tumors (MMMT), have also been reported. Uterine sarcoma is generally associated with a higher FIGO stage (III/IV) at diagnosis, poorer prognosis, and shorter survival. Uterine sarcoma has been reported to occur more frequently among long-term users (≥ 2 years) of tamoxifen citrate than non-users. Some of the uterine malignancies (e…
Contraindications
CONTRAINDICATIONS Tamoxifen citrate tablets are contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. Reduction in Breast Cancer Incidence in High Risk Women and Women with DCIS: Tamoxifen citrate tablets are contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus.
Drug Interactions
Drug Interactions: When tamoxifen citrate is used in combination with coumarin-type anticoagulants, a significant increase in anticoagulant effect may occur. Where such coadministration exists, careful monitoring of the patient’s prothrombin time is recommended. In the NSABP P-1 trial, women who required coumarin-type anticoagulants for any reason were ineligible for participation in the trial (See CONTRAINDICATIONS ). There is an increased risk of thromboembolic events occurring when cytotoxic agents are used in combination with tamoxifen citrate. Tamoxifen reduced letrozole plasma concentrations by 37%. The effect of tamoxifen on metabolism and excretion of other antineoplastic drugs, such as cyclophosphamide and other drugs that require mixed function oxidases for activation, is not known. Tamoxifen and N-desmethyl tamoxifen plasma concentrations have been shown to be reduced when coadministered with rifampin or aminoglutethimide. Induction of CYP3A4-mediated metabolism is considered to be the mechanism by which these reductions occur; other CYP3A4 inducing agents have not been studied to confirm this effect. One patient receiving tamoxifen citrate with concomitant phenobarbital…
Adverse Reactions
ADVERSE REACTIONS Adverse reactions to tamoxifen citrate are relatively mild and rarely severe enough to require discontinuation of treatment in breast cancer patients. Continued clinical studies have resulted in further information which better indicates the incidence of adverse reactions with tamoxifen citrate as compared to placebo. Metastatic Breast Cancer: Increased bone and tumor pain and, also, local disease flare have occurred, which are sometimes associated with a good tumor response. Patients with increased bone pain may require additional analgesics. Patients with soft tissue disease may have sudden increases in the size of pre-existing lesions, sometimes associated with marked erythema within and surrounding the lesions and/or the development of new lesions. When they occur, the bone pain or disease flare are seen shortly after starting tamoxifen citrate and generally subside rapidly. In patients treated with tamoxifen citrate for metastatic breast cancer, the most frequent adverse reaction to tamoxifen citrate is hot flashes. Other adverse reactions which are seen infrequently are hypercalcemia, peripheral edema, distaste for food, pruritus vulvae, depression, dizzines…
Frequently Asked Questions
What is Tamoxifen Citrate used for?
Tamoxifen Citrate contains Tamoxifen Citrate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Tamoxifen Citrate a controlled substance?
Tamoxifen Citrate is not classified as a controlled substance by the DEA.
What is the generic name for Tamoxifen Citrate?
The generic name for Tamoxifen Citrate is Tamoxifen Citrate. There are 1 other brand versions of Tamoxifen Citrate.
What is the NDC code for Tamoxifen Citrate 10 mg/1?
The NDC (National Drug Code) for Tamoxifen Citrate 10 mg/1 is 75907-058, listed by Dr. Reddy's Labratories Inc..
Other Tamoxifen Citrate Dosages
- Tamoxifen Citrate10 mg/10591-2472
- Tamoxifen Citrate20 mg/163187-976
- Tamoxifen Citrate20 mg/10378-0274
- Tamoxifen Citrate20 mg/150090-0942
- Tamoxifen Citrate20 mg/159651-300
- Tamoxifen Citrate10 mg/168071-3990
- Tamoxifen Citrate10 mg/172162-2225
- Tamoxifen Citrate10 mg/150090-0485
- Tamoxifen Citrate10 mg/168071-5254
- Tamoxifen Citrate20 mg/172162-2209
Other Tamoxifen Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)