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Admafen 10/20 Tablets

Generic Name– Tamoxifen citrate
Drug Class – Antineoplastic agent
Tamoxifen is a nonsteroidal antiestrogen, indicated for the treatment of advanced disease in postmenopausal women and palliative treatment of premenopausal women with estrogen receptor (ER) positive disease. It acts by inhibiting estrogen binding to its receptor, essential for its activity in breast cancer cells. It also leads to an increase in sex hormone binding globulin and decrease in insulin like growth factor 1 and tumor growth α. These changes reduce factors that stimulate tumor growth and induce apoptosis in estrogen receptor positive cells.

Category

Product Description

Admafen 10/20 (Tamoxifen) is an oral anti cancer drug available in tablet unit dosage form.

Indications and Usage

Tamoxifen is indicated for:
• Treatment of adult patients with estrogen receptor-positive metastatic breast cancer
• Adjuvant treatment of adult patients with early stage estrogen receptor positive breast cancer
• Reducing the incidence of breast cancer in adult women at high risk
• Reducing risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS)

Dosage and Administration

  • Recommended dose in metastatic breast cancer: 20-40 mg per day, if dose is greater than 20 mg per day then administer in divided doses (morning and evening)
  • Recommended dose for adjuvant treatment of breast cancer, DCIS, reduction of breast cancer incidence in women at high risk: 20 mg per day3


Dosage Forms and Strengths

• Supplied as tablets for oral use
• Available in 10mg and 20mg strength

Clinical Efficacy

• Exhibits estrogen-like activities in postmenopausal women, preserve bone function in the lumbar spine and decrease circulating cholesterol2
• Shows higher efficacy with a lower incidence of side effects when used as an adjuvant therapy for women with node-positive breast cancer2
• Provide maximal benefit in preventing recurrence in postmenopausal women with node-positive disease2
• Increases disease-free survival of both pre- and postmenopausal patients with ER-positive tumors

Adverse Reactions
• The most common adverse events that occurs after administration of tamoxifen are nausea, hot flashes, fluid retention, mood disturbances, vaginal discharge and vaginal bleeding

Contraindications
• It is contraindicated in patients with a known hypersensitivity to tamoxifen or any other ingredient present in formulation
• It is contraindicated in patients who require concomitant warfarin therapy or have a history of deep vein thrombosis or pulmonary embolus if the indication for treatment is either reduction of breast cancer incidence in high-risk patients or risk reduction of invasive breast cancer after treatment of DCIS

Special Precautions

• Evaluate the abnormal vaginal bleeding in women with current or past tamoxifen use, to determine the risk of uterine malignancies
• Consider risks and benefits of tamoxifen in patients with a history of thromboembolic events as risk of thromboembolic events increases with tamoxifen alone or in combination with other chemotherapy drugs
• Perform periodic liver function testing to determine the risk of secondary malignancies, liver cancer and other liver abnormalities
• Discontinue treatment with tamoxifen in patients with severe hypercalcemia
• Monitor periodic complete blood counts, including platelet counts during treatment with tamoxifen, as hematologic effects such as leucopenia, neutropenia and pancytopenia have been reported in patients receiving tamoxifen
• Do not use anastrozole and letrozole in combination with tamoxifen
• Tamoxifen can cause fetal harm when administered to pregnant women, so advise females of reproductive potential to use effective contraceptives
• It is not recommended for use in breast feeding mothers

Admafen 10/20 Tablets - ADMAC Life Science