TAMOX
(Instructions for medical use of therapeutic agents)
Registration number Mfg: HP/DRUGS/STB66/11S2-C.
Active substance: Tamox.
Packaging: Two blister packs of 50 tablets.
Dosage: 20 mg/tab of Tamoxifen Citrate.
Category drugs: Selective Estrogen Receptor Modulator.
Pharmacological properties:
Tamoxifen is a non-steroidal, triphenylethylene-based drug which 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. In the clinical situation, it is recognised that tamoxifen leads to reductions in levels of blood total cholesterol and low density lipoproteins in postmenopausal women of the order of 10 - 20%. Tamoxifen does not adversely affect bone mineral density.
Indications for use:
Breast Cancer Treatment
- 20-40 mg/day orally; doses greater than 20mg/day should be divided twice daily (i.e., morning and evening)
- Although the FDA has approved a dosage range of 20-40 mg/day, clinical benefit for doses greater than 20 mg/day has not been demonstrated
- Continue with adjuvant therapy for at least 5 years
- For women with ER-positive disease, continuing tamoxifen to 10 years rather than stopping at 5 years produces a further reduction in recurrence and mortality, particularly after year 10
- Treatment indications:
- Treatment of metastatic breast cancer in women and men; in premenopausal women, alternative to oophorectomy or ovarian irradiation; estrogen receptor positive tumors more likely to benefit
- Adjuvant treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissectio
n, and breast irradiation; most benefit in the subgroup with 4 or more positive axillary nodes - Adjuvant treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation
- Reduces occurrence of contralateral breast cancer in patients receiving adjuvant treatment
Breast Cancer Treatment
- 20-40 mg/day orally; doses greater than 20mg/day should be divided twice daily (i.e., morning and evening)
- Although the FDA has approved a dosage range of 20-40 mg/day, clinical benefit for doses greater than 20 mg/day has not been demonstrated
- Continue with adjuvant therapy for at least 5 years
- For women with ER-positive disease, continuing tamoxifen to 10 years rather than stopping at 5 years produces a further reduction in recurrence and mortality, particularly after year 10
- Treatment indications:
- Treatment of metastatic breast cancer in women and men; in premenopausal women, alternative to oophorectomy or ovarian irradiation; estrogen receptor positive tumors more likely to benefit
- Adjuvant treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation; most benefit in the subgroup with 4 or more positive axillary nodes
- Adjuvant treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation
- Reduces occurrence of contralateral breast cancer in patients receiving adjuvant treatment
Ductal Carcinoma in Situ (DCIS)
- Indicated in women with ductal carcinoma in situ following breast surgery and radiation to reduce the risk of invasive breast cancer
- 20 mg orally once/day for 5 years
Breast Cancer Prevention
- Indicated to reduce the incidence of breast cancer in women at high risk for breast cancer; high risk is defined as women aged 35 years or older with a 5-year predicted risk of breast cancer 1.67% or more (calculated by the Gail Model)
- 20 mg orally once/day for 5 years
- Data are limited for use greater than 5 years in the risk-reduction setting (NCCN guidelines)
Ovulation Induction (Off-label)
- 10-40 mg orally every 12 hours for 4 days
Mastalgia (Off-label)
- 20 mg orally once/day for 4 months
Other Indications and Uses
- Gynecomastia
Contraindications:
Tamoxifen should not be used in the following:
• Pregnancy. Pre-menopausal patients must be carefully examined before treatment for all indications to exclude the possibility of pregnancy
• Concurrent anastrozole therapy
Treatment for infertility
Tamoxifen should not be used in:
• Patients with a personal or family history of confirmed idiopathic venous thromboembolic events or a known genetic defect.
Primary prevention of breast cancer
Tamoxifen should not be used in:
• Women with a history of deep vein thrombosis or pulmonary embolus.
• Women who require concomitant coumarin-type anticoagulant therapy
Side Effects:
Common side effects or health problems may include:
- Abdominal cramps
- Absence of menstrual periods
- Bone pain
- Cataracts
- Changes in menstrual periods
- Cough
- Depression
- Difficulty having an orgasm
- Dizziness
- Fatigue
- Fluid retention
- Hair thinning
- Headache
- Hot flashes
- Impotence
- Infrequent or light menstrual periods
- Joint pain
- Leg cramps
- Loss of appetite
- Muscle aches
- Musculoskeletal pain
- Nausea
- Ovarian cyst
- Swelling (edema) in your hands or feet
- Fluid retention
- Tumor pain
- Vaginal discharge
- Vaginal itching or dryness
- Weight loss
Less common side effects of tamoxifen include:
- Skin swelling
- Corneal changes
- Loss of sex drive (libido)/decreased sexual ability
- Endometrial cancer
- Pancreatitis
- Retinal vein thrombosis
- Stroke
- Uterine fibroids
Interactions with other drugs: Оverdose will increase the pharmacological side effects mentioned above
Storage conditions: Store in a cool, dark, dry place at a temperature of from 15 to 30 degrees. Avoid contact with direct sunlight. Keep away from children.
Attention: do not take the medication after the expiration date.
Sales category: on medical prescription.
Expiration date: 6 years from the date of issue. The date on the package.
AllChem Asia
(GMP Certified company)
Pharma City Road, Selakui,
Uttarakhand 248011, India