TAMOXIFEN

Indications and Dosage
Oral
Reduction of breast cancer incidence in women at high risk
Adult: 20 mg daily for 5 years.

Oral
Breast cancer
Adult: Usual dose: 20 mg daily, given as a single dose or in 2 divided doses. Doses of up to 40 mg daily may be given in advanced or metastatic cases; however, no additional clinical benefit has been demonstrated.

Oral
Anovulatory infertility
Adult: In women with regular menstruation, but with anovular cycles: Initially, 20 mg daily given on days 2-5 of the menstrual cycle. If initial treatment course is unsuccessful, doses may be increased during subsequent menstrual periods to 40 mg then to 80 mg daily. In women with irregular menstruation: Initial course may begin on any day; if there is no response, a subsequent treatment course may start 45 days later with the dose increased to 40 mg then to 80 mg daily. If patient responds with menstruation, then the next course is started on the 2nd day of the cycle.
Administration
May be taken with or without food.
Contraindications
History of DVT or pulmonary embolism (when used for treatment of infertility, and risk reduction of breast cancer in high-risk women). Pregnancy and lactation. Concurrent use with anastrozole. Concomitant coumarin-type anticoagulant therapy (when used in risk reduction of breast cancer in high-risk women).
Special Precautions
Patient with risk factors for thromboembolic events (e.g. family history of venous thrombosis, smoking, obesity); pre-menopausal women. Patient undergoing major surgery or prolonged immobility (refer to detailed product guideline for recommendations on dosing interruption or discontinuation). CYP2D6 intermediate and poor metabolisers.
Adverse Reactions
Significant: Bone marrow suppression (e.g. thrombocytopenia, leucopenia, neutropenia, pancytopenia); hepatocellular carcinoma, elevated transaminases; ocular effects (e.g. retinal vein thrombosis, retinopathy, corneal changes, colour perception changes, cataracts); changes in bone mineral density, hypercholesterolaemia, hyperlipidaemia, hypercalcaemia; local disease flare, increased bone and tumour pain; abnormal gynaecological symptoms (e.g. endometrial hyperplasia, polyps, endometriosis, uterine fibroids, ovarian cysts, amenorrhoea, menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, pelvic pain or pressure). Rarely, radiation recall (reversible).
Blood and lymphatic system disorders: Anaemia.
General disorders and administration site conditions: Fatigue, asthenia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dysgeusia.
Immune system disorders: Hypersensitivity reactions.
Investigations: Increased triglycerides.
Metabolism and nutrition disorders: Fluid retention.
Musculoskeletal and connective tissue disorders: Myalgia, leg cramp, arthralgia.
Nervous system disorders: Headache, light-headedness, dizziness, paraesthesia, ischaemic cerebrovascular events.
Psychiatric disorders: Mood disturbances, depression.
Reproductive system and breast disorders: Pruritus vulvae.
Respiratory, thoracic and mediastinal disorders: Pharyngitis.
Skin and subcutaneous tissue disorders: Rash, alopecia.
Vascular disorders: Hot flushes, hypertension.
Potentially Fatal: Thromboembolic events (e.g. stroke, DVT, pulmonary embolism), uterine malignancies (e.g. endometrial adenocarcinoma, uterine sarcoma), severe hepatic abnormalities (e.g. fatty liver, cholestasis, hepatitis, hepatic necrosis).
Monitoring Parameters
Evaluate pregnancy status, and calculate patient’s risk for developing breast cancer according to local guidelines (for the reduction of cases in women at high risk) before treatment initiation. May consider CYP2D6 gene testing prior therapy. Monitor CBC with platelets, serum Ca, LFTs, triglycerides and cholesterol (in patient with hyperlipidaemia) periodically; abnormal gynaecologic symptoms (e.g. abnormal vaginal bleeding, menstrual irregularities, pelvic pain or pressure); bone mineral density (particularly in premenopausal women); signs and symptoms of DVT and pulmonary embolism. Perform breast and gynaecologic exams, and mammogram at baseline and routinely thereafter; ophthalmic exam as necessary.
Overdosage
Symptoms: Acute neurotoxicity (e.g. dizziness, tremor, hyperreflexia, unsteady gait), QT prolongation. Management: Symptomatic treatment.
Drug Interactions
Increased risk of thromboembolic events with cytotoxic agents. May decrease plasma concentrations with CYP3A4 inducers (e.g. rifampicin, aminoglutethimide). Diminished therapeutic efficacy with CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, cinacalcet, bupropion, quinidine). Increased serum concentration with bromocriptine. Effectiveness of tamoxifen may be reduced by hormone replacement therapy or oral hormonal contraceptives. May reduce the plasma levels of letrozole.
Potentially Fatal: Significantly increased effect of coumarin anticoagulants (e.g. warfarin).
Food Interaction
May decrease metabolism with grapefruit juice.
Lab Interference
May cause an elevation in T4 not accompanied by clinical hyperthyroidism. May cause variations with vagina smear karyopyknotic index and Pap smear estrogen effects
Storage
Tab: Store below 30°C. Protect from light. Oral solution: Store between 20-25°C. Do not freeze or refrigerate. Protect from light. Follow applicable procedures for receiving, handling, administration, and disposal.
MIMS Class
Cancer Hormone Therapy / Other Drugs Affecting Hormonal Regulation
ATC Classification
L02BA01 - tamoxifen ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.
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