Product Name: Tamoxifen
Active Ingredient:
Tamoxifen Citrate
Description:
Tamoxifen is a selective estrogen receptor modulator (SERM) used in the treatment of hormone receptor-positive breast cancer and other estrogen-dependent conditions. It functions by binding to estrogen receptors on cells, blocking the effects of estrogen, and preventing the growth of estrogen-dependent cancer cells. Tamoxifen is commonly used both as adjuvant therapy in breast cancer treatment and for the prevention of recurrence in patients with a history of breast cancer.
Quantitative and Qualitative Composition:
- Active Substance: Each tablet contains 20 mg of tamoxifen citrate.
- Excipients: Cellulose, magnesium stearate.
Pharmaceutical Form:
White, circular tablets for oral administration.
Packaging:
40 tablets per container.
Pharmacotherapeutic Classification:
Selective estrogen receptor modulators (SERM) (ATC Code: L02BA01)
Therapeutic Indications:
- Breast Cancer Treatment: Tamoxifen is used to treat estrogen receptor-positive breast cancer in both men and women, including as an adjuvant treatment to reduce the risk of recurrence following surgery and radiation therapy.
- Breast Cancer Prevention: It is prescribed for women at high risk of developing breast cancer as a preventive measure.
- Infertility Treatment: In some cases, tamoxifen is used off-label to treat infertility in women with ovulatory dysfunction.
- Gynecomastia Prevention: Tamoxifen can be used in men undergoing treatment for prostate cancer to prevent gynecomastia induced by hormone therapy.
Dosage and Administration:
Tamoxifen is typically administered orally in the form of tablets. The dosage varies depending on the condition being treated:
- For breast cancer, the usual dose is 20 mg daily, which may be increased to 40 mg depending on clinical response.
- For infertility treatment, the typical dose is 10–20 mg daily for a specific period as prescribed by a healthcare provider.
- For prevention of recurrence of breast cancer, the dose is often 20 mg daily for a period of 5 years, but this should be determined by a physician.
Storage Conditions:
Store below 25°C. Protect from moisture and light. Keep out of reach of children.
Regulatory Status:
Prescription-only medication (Rx).
Manufactured in accordance with current Good Manufacturing Practice (cGMP) standards.