Tamoral
Generic Name
Tamoxifen Citrate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tamoral 20 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Tamoxifen is an anti-estrogen medication used in the treatment and prevention of breast cancer. It works by blocking estrogen's effects on breast tissue.
Uses & Indications
Dosage
Adults
For early breast cancer: 20 mg once daily for 5-10 years. For metastatic breast cancer: 20 mg to 40 mg daily, typically as a single dose or in two divided doses.
Elderly
No specific dose adjustment is generally required for elderly patients, but monitoring for adverse effects and comorbidities is recommended.
Renal_impairment
No dose adjustment is routinely required for patients with renal impairment.
How to Take
Tamoral tablets should be taken orally, with or without food. It can be taken as a single dose or in two divided doses (morning and evening).
Mechanism of Action
Tamoxifen is a Selective Estrogen Receptor Modulator (SERM). It competitively binds to estrogen receptors in breast cancer cells, preventing estrogen from binding and stimulating cell growth. It exhibits both estrogenic and anti-estrogenic effects depending on the tissue.
Pharmacokinetics
Onset
Therapeutic effects may take several weeks or months to become evident, especially in cancer treatment. Anti-estrogenic effects are seen acutely.
Excretion
Primarily excreted in feces after hepatic metabolism and enterohepatic recirculation, with a small amount excreted in urine.
Half life
Tamoxifen: 5-7 days; N-desmethyltamoxifen (major active metabolite): 7-14 days.
Absorption
Well absorbed orally, with peak plasma concentrations occurring within 3-7 hours. Food does not significantly affect absorption.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4 to N-desmethyltamoxifen and by CYP2D6 to 4-hydroxytamoxifen, both active metabolites. These are further metabolized.
Side Effects
Contraindications
- Hypersensitivity to tamoxifen or any component of the tablet.
- Concomitant anastrozole use in the adjuvant setting.
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) for breast cancer risk reduction.
Drug Interactions
Warfarin
Increased anticoagulant effect, requiring close monitoring of INR.
Estrogens
May interfere with the therapeutic effects of tamoxifen.
CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion)
May reduce plasma concentrations of endoxifen (active metabolite), potentially decreasing efficacy. Co-administration should be avoided if possible.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include increased side effects such as hot flashes, bleeding, and dizziness. There is no specific antidote. Management should be symptomatic and supportive.
Pregnancy & Lactation
Tamoxifen is classified as Pregnancy Category D. It may cause fetal harm and should not be used during pregnancy. It is excreted in breast milk, so breastfeeding is not recommended during treatment.
Side Effects
Contraindications
- Hypersensitivity to tamoxifen or any component of the tablet.
- Concomitant anastrozole use in the adjuvant setting.
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) for breast cancer risk reduction.
Drug Interactions
Warfarin
Increased anticoagulant effect, requiring close monitoring of INR.
Estrogens
May interfere with the therapeutic effects of tamoxifen.
CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion)
May reduce plasma concentrations of endoxifen (active metabolite), potentially decreasing efficacy. Co-administration should be avoided if possible.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include increased side effects such as hot flashes, bleeding, and dizziness. There is no specific antidote. Management should be symptomatic and supportive.
Pregnancy & Lactation
Tamoxifen is classified as Pregnancy Category D. It may cause fetal harm and should not be used during pregnancy. It is excreted in breast milk, so breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Tamoxifen has been extensively studied in numerous clinical trials establishing its efficacy in various settings of breast cancer. Ongoing research explores its role in personalized medicine and long-term outcomes.
Lab Monitoring
- Complete blood count (CBC) periodically.
- Liver function tests (LFTs) periodically.
- Calcium levels (especially in patients with bone metastases).
- Gynecological examinations, including endometrial biopsies, to monitor for uterine abnormalities.
Doctor Notes
- Counsel patients thoroughly about the benefits and risks, particularly the rare but serious risks of uterine malignancy and thromboembolic events.
- Emphasize the importance of adherence to therapy and regular follow-up appointments, including gynecological examinations.
- Consider CYP2D6 genotyping in selected patients, especially those not responding to therapy or experiencing severe side effects, although routine testing is not universally recommended.
Patient Guidelines
- Take the medication exactly as prescribed by your doctor.
- Report any unusual vaginal bleeding, discharge, or pelvic pain immediately.
- Be aware of signs of blood clots (e.g., pain/swelling in leg, chest pain, sudden shortness of breath) and seek immediate medical attention.
- Undergo regular gynecological check-ups and mammograms as advised by your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Tamoral may cause blurred vision or dizziness in some patients. Patients should exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain a healthy weight through a balanced diet and regular exercise.
- Avoid smoking and excessive alcohol consumption to reduce overall health risks.
- Discuss bone health and potential calcium/Vitamin D supplementation with your doctor.
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