Tamodex
Generic Name
Tamoxifen Citrate
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tamodex 10 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Tamodex 10 mg Tablet contains Tamoxifen, an anti-estrogen medication used in the treatment and prevention of breast cancer in women and men. It is a selective estrogen receptor modulator (SERM) that blocks the effects of estrogen in breast tissue.
Uses & Indications
Dosage
Adults
Breast Cancer: 20-40 mg daily, given as a single dose or in two divided doses (e.g., 10 mg twice daily). Risk Reduction: 20 mg daily for 5 years.
Elderly
No specific dose adjustment is generally required, but caution is advised due to potential comorbidities.
Renal_impairment
No dose adjustment needed for mild to moderate renal impairment. Data for severe impairment is limited.
How to Take
Take orally, with or without food. Swallow the tablet whole with water. If taking two doses per day, try to space them evenly apart.
Mechanism of Action
Tamoxifen is a selective estrogen receptor modulator (SERM). It acts as an estrogen antagonist in breast tissue by binding to estrogen receptors, preventing estrogen from binding and stimulating cell growth. In other tissues, like bone and endometrium, it can act as an estrogen agonist.
Pharmacokinetics
Onset
Therapeutic effects may take several weeks to months.
Excretion
Excreted primarily in feces, with a small amount excreted in urine.
Half life
Approximately 5-7 days for tamoxifen; 7-14 days for its active metabolite, N-desmethyltamoxifen (endoxifen).
Absorption
Well absorbed orally; peak plasma concentrations reached within 4-7 hours.
Metabolism
Extensively metabolized in the liver primarily by CYP3A4, CYP2D6, and CYP2C9 enzymes to active metabolites, especially endoxifen.
Side Effects
Contraindications
- Hypersensitivity to tamoxifen or any component of the formulation.
- Concomitant warfarin therapy (when used for risk reduction).
- History of deep vein thrombosis or pulmonary embolism (when used for risk reduction).
Drug Interactions
Warfarin
Increased anticoagulant effect, leading to increased risk of bleeding. Close monitoring of INR is required.
CYP3A4 inducers (e.g., Rifampicin)
May decrease tamoxifen levels, potentially reducing efficacy.
SSRIs (e.g., Paroxetine, Fluoxetine)
May reduce tamoxifen's effectiveness by inhibiting CYP2D6, which metabolizes tamoxifen to its active metabolite endoxifen.
CYP3A4 inhibitors (e.g., Ketoconazole)
May increase tamoxifen levels and potentially its side effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include tremor, hyperreflexia, and unsteady gait. There is no specific antidote. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category D. Can cause fetal harm. Not recommended during pregnancy. Women of childbearing potential should use effective non-hormonal contraception during treatment and for two months after the last dose. It is unknown if tamoxifen is excreted in human milk; due to the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended.
Side Effects
Contraindications
- Hypersensitivity to tamoxifen or any component of the formulation.
- Concomitant warfarin therapy (when used for risk reduction).
- History of deep vein thrombosis or pulmonary embolism (when used for risk reduction).
Drug Interactions
Warfarin
Increased anticoagulant effect, leading to increased risk of bleeding. Close monitoring of INR is required.
CYP3A4 inducers (e.g., Rifampicin)
May decrease tamoxifen levels, potentially reducing efficacy.
SSRIs (e.g., Paroxetine, Fluoxetine)
May reduce tamoxifen's effectiveness by inhibiting CYP2D6, which metabolizes tamoxifen to its active metabolite endoxifen.
CYP3A4 inhibitors (e.g., Ketoconazole)
May increase tamoxifen levels and potentially its side effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include tremor, hyperreflexia, and unsteady gait. There is no specific antidote. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category D. Can cause fetal harm. Not recommended during pregnancy. Women of childbearing potential should use effective non-hormonal contraception during treatment and for two months after the last dose. It is unknown if tamoxifen is excreted in human milk; due to the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies worldwide
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Tamoxifen has been extensively studied in numerous clinical trials establishing its efficacy and safety in various breast cancer settings, including adjuvant, metastatic, and risk reduction.
Lab Monitoring
- Complete blood count (CBC) periodically.
- Liver function tests (LFTs) periodically.
- Calcium levels (if metastatic disease with bone involvement).
- Gynecological examinations annually to check for endometrial changes.
Doctor Notes
- Counsel patients on potential risks, especially VTE and endometrial cancer.
- Monitor for signs and symptoms of these serious adverse events.
- Consider CYP2D6 genotyping for patients with suboptimal response or significant drug interactions.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Report any unusual vaginal bleeding, discharge, or pelvic pain immediately.
- Be aware of symptoms of blood clots (e.g., chest pain, shortness of breath, leg swelling) and seek urgent medical attention if they occur.
- Discuss all other medications, including over-the-counter drugs and herbal supplements, with your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Tamoxifen may cause fatigue or blurred vision in some patients. If these symptoms occur, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy weight and engage in regular physical activity.
- Avoid smoking and excessive alcohol consumption.
- Regular screenings for breast cancer and gynecological health are important.
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