NOLVABOLIC - Tamoxifen Citrate 20 mg

Category:- Hormones | Type:- Tablet

COMPOSITION

Each Tablet Contains: Tamoxifen citrate 20 mg

PHARMACOLOGICAL CLASSIFICATION

A 26 Cytostatic agents.

PHARMACOLOGICALACTION

Nolvabolic is an anti-oestrogenic agent that blocks the peripheral functions of oestrogens on target tissues. Nolvabolic binds to oestrogen receptors in a fashion similar to that of oestradiol. The complex of the receptor and the anti-oestrogen may bind to nuclear chromatin in a typical manner and for a longer time than the normal hormone-receptor complex. Furthermore, anti-oestrogens may deplete the cytoplasm of free receptors. Either or both of these effects could severely impair the growth of an oestrogen dependant tumour. Nolvabolic also prevents the normal “feedback inhibition” of control of oestrogen synthesis in the hypothalamus and pituitary gland and this causes an increased secretion of luteinising hormone release factor follicle stimulating hormone release factor and gonadotropins. The formation of large and cystic ovaries is the result of increased concentrations of gonadotropins, leading to ovarian stimulation, ovulation, and sustained function of corpora lutea.

INDICATIONS

Palliative treatment of advanced carcinoma of the breast in postmenopausal women.

CONTRA-INDICATIONS

Nolvabolic should not be given during pregnancy, and should be used with caution in women with functioning ovaries.

WARNINGS

Endometrial changes: An increased incidence of endometrial changes, including hyperplasia, polyps and cancer has been reported in association with tamoxifen treatment. Any patients receiving or having previously received tamoxifen, who report vaginal bleeding, should be promptly investigated.

DOSAGE AND DIRECTIONS FOR USE

In the management of breast cancer Initial dose: 10 mg twice daily. If no response is seen within one month, the dosage should be increased to 20 mg twice daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

Adverse effects with Nolvabolic include hot flushes, oedema, vaginal bleeding, pruritus vulvae, gastrointestinal disturbances, dizziness, rashes, hypercalcaemia, and tumour pain. Transient thrombocytopenia and leucopenia have been reported. There have also been reports of headache, depression, fatigue, confusion, leg cramps, alopecia and dry skin. There may be an increased tendency to develop deep vein thromboses; pulmonary embolism has occurred. Hypercalcaemia may develop in patients with bony metastases. Blurred vision and loss of visual acuity, corneal opacities, and retinopathies have occurred, mostly following administration of very high doses. In pre-menopausal women, Nolvabolic completely suppresses menstruation and cystic ovarian swelling may develop. Tamoxifen was genotoxic in some in-vitro and in-vivo genotoxicity tests in rodents. Gonadal tumours in mice, and liver tumours in rats receiving tamoxifen have been reported in long-term studies. The clinical relevance of these findings has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

See “Side-effects and Special Precautions”. Treat symptomatically.

PRESENTATION 3 x 10 tablets in a blister packed in carton along with package insert.

STORAGE INSTRUCTIONS

Store below 30°C in a dry place Protect from light.

KEEP OUT OF REACH OF CHILDREN.

Manufactured by: COOPER PHARMALIMITED