Nolvadex-D

Nolvadex-D

tamoxifen

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Tamoxifen
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concurrent anastrozole therapy. Pregnancy.
Special Precautions
Discontinue treatment in case of signs & symptoms suggestive of severe cutaneous adverse reactions. Suppressed menstruation in a proportion of premenopausal women receiving treatment. Increased incidence of endometrial changes including hyperplasia, polyps, cancer & uterine sarcoma. Reports of 2nd primary tumours at sites other than the endometrium & the opposite breast. Increased risk for VTE. May increase risk of microvascular flap complications in delayed microsurgical breast reconstruction. Promptly investigate any patient who reports abnormal gynaecological symptoms, especially non-menstrual vag bleeding, or who presents w/ menstrual irregularities, vag discharge & symptoms (eg, pelvic pain or pressure). May induce or exacerbate symptoms of angioedema in patients w/ hereditary angioedema. Avoid concomitant use w/ potent CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, cinacalcet, bupropion). Very rarely, reports of radiation recall in patients who received prior RT. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Reports of fatigue; observe caution when driving or operating machinery. Advise women not to become pregnant during treatment & for 9 mth following the cessation of therapy; use barrier or other non-hormonal contraceptive methods. Carefully examine premenopausal patients before treatment to exclude pregnancy. Potential foetal risk. Not recommended during breastfeeding. Not recommended in childn. Girls 2-10 yr w/ McCune Albright syndrome. CYP2D6 poor metabolisers.
Adverse Reactions
Fluid retention; hot flushes; nausea; skin rash; vag bleeding/discharge; fatigue; depression. Uterine fibroids; anaemia; hypersensitivity reactions; ischaemic cerebrovascular events, headache, light headedness, sensory disturbances (including paraesthesia & dysgeusia); cataracts, retinopathy; thromboembolic events (including DVT, microvascular thrombosis & pulmonary embolism); vomiting, diarrhoea, constipation; changes in liver enzymes, fatty liver; alopecia; leg cramp, myalgia; pruritus valvae, endometrial changes (including hyperplasia & polyps); elevated triglycerides.
Drug Interactions
Increased anticoagulant effect w/ coumarin-type anticoagulants. Increased risk of thromboembolic events w/ cytotoxic agents. Reduced plasma levels w/ rifampicin (CYP3A4 inducer). Reduced plasma levels of endoxifen (active metabolite) w/ CYP2D6 inhibitors. Reduced efficacy w/ some SSRI antidepressants (eg, paroxetine). Combination w/ anastrozole as adjuvant therapy has not shown improved efficacy compared w/ tamoxifen alone.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BA01 - tamoxifen ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Nolvadex-D FC tab 20 mg
Packing/Price
30's
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