Tamoxifen Citrate

Tamona is indicated for the treatment of Breast cancer and Infertility.

Tamoxifen is a praparation of Tamoxifen which is a non-steroidal, triphenylene based drug and displays a complex spectrum of oestrogen antagonist and oestrogen agonist like pharmacological effects in different tissues. In breast cancer patients, at the tumour level, Tamoxifen acts primarily as an antioestrogen, preventing oestrogen binding to the oestrogen receptor. Additionally Tamoxifen has been reported to lead to maintenance of bone mineral density in post-menopausal women.

Breast cancer : 20 mg daily. Anovulatory Infertility : 20mg daily on days 2, 3, 4 and 5 of cycle; if necessary the dose may be increased to 40 mg then 80 mg for subsequent courses; if cycles are irregular, start initial course on any day, with subsequent course 45 days later or on day 2 of cycle if menstruation occurs.

Side effects can be classified as either due to the pharmacological action of the drug, e.g., hot flushes, vaginal bleeding, vaginal discharge, pruritus vulvae and tumour flare or as more general side effects, e.g., gastrointestinal intolerance, headache, light-headedness and occasionally fluid retention and alopecia. When such side effects are severe, it may be possible to control them by a simple reduction of dosage (within the recommended dose range) without loss of control of the disease. Skin rashes including isolated reports of erythema multiforme, Stevens Johnson syndrome and bullous pemphigoid and rare hypersensitivity reactions, including angio-oedema have been reported. A small number of patients with bony metastases have developed hypercalcaemia on initiation of therapy. Falls in platelet count, usually only to 80,000-90,000 per/mm3 but occasionally lower, have been reported in patients taking Tamona for breast cancer. A number of cases of visual disturbances including infrequent reports of corneal changes and retinopathy have been described in patients receiving Tamona therapy. An increased incidence of cataracts has been reported in association with the administration of the drug. Uterine fibroids and endometrial changes including hyperplasia and polyps have been reported. Cystic ovarian swellings have occasionally been observed in premenopausal women receiving Tamona. Leucopenia has been observed following the administration of Tamona, sometimes in association with anaemia and/or thrombocytopenia. Neutropenia has been reported on rare occasions; this can sometimes be severe. There is evidence of an increased incidence of thromboembolic events including deep vein thrombosis and pulmonary embolism during Tamona therapy. Tamona has been associated with changes in liver enzyme levels and on rare occasions with a spectrum of more severe liver abnormalities, including fatty liver, cholestasis and hepatitis. Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Tamona.