Tamodex
Generic Name
Tamoxifen Citrate
Manufacturer
ACME Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tamodex 20 mg tablet | ৳ 16.00 | ৳ 160.00 |
Description
Overview of the medicine
Tamodex 20 mg Tablet contains Tamoxifen Citrate, a non-steroidal anti-estrogen, primarily used in the treatment of breast cancer that is estrogen receptor-positive. It acts by blocking estrogen receptors in breast tissue, thereby inhibiting the growth of cancer cells.
Uses & Indications
Dosage
Adults
For breast cancer, typically 20 mg to 40 mg daily, usually given as 20 mg once daily or 10 mg twice daily. Duration of therapy is usually 5 to 10 years.
Elderly
No specific dosage adjustment required, but caution is advised due to potential comorbidities and polypharmacy.
Renal_impairment
No specific dosage adjustment recommended as Tamoxifen is primarily metabolized in the liver and excreted via feces.
How to Take
Take the tablet orally with water, with or without food. It can be taken as a single daily dose or divided into two doses (morning and evening).
Mechanism of Action
Tamoxifen is a Selective Estrogen Receptor Modulator (SERM). In breast tissue, it acts as an estrogen receptor antagonist, binding to estrogen receptors and preventing estrogen from stimulating cancer cell growth. In other tissues (like bone), it may act as an estrogen agonist.
Pharmacokinetics
Onset
Therapeutic effects may take several weeks to months to become evident.
Excretion
Mainly excreted via feces after hepatic metabolism; a small amount is excreted in urine.
Half life
Approximately 5-7 days for tamoxifen; 7-14 days for N-desmethyltamoxifen (active metabolite).
Absorption
Well absorbed orally; peak plasma concentrations reached within 4-7 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4, CYP2D6, and CYP2C9, to active metabolites like N-desmethyltamoxifen and 4-hydroxytamoxifen.
Side Effects
Contraindications
- Hypersensitivity to tamoxifen or any component of the formulation.
- Concomitant anastrozole use.
- Women requiring coumarin-type anticoagulant therapy or with a history of deep vein thrombosis or pulmonary embolism (for risk reduction indication).
Drug Interactions
Warfarin
Increased anticoagulant effect; monitor INR closely.
Anastrozole
Concomitant use is contraindicated.
CYP3A4 inducers/inhibitors
May alter tamoxifen levels.
SSRIs (e.g., Paroxetine, Fluoxetine)
May decrease tamoxifen's effectiveness due to CYP2D6 inhibition; consider alternative antidepressants.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include exaggeration of known adverse effects like neurotoxicity (tremor, hyperreflexia, unsteady gait), prolongation of QT interval. Management is supportive, including monitoring vital signs and ECG.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Not recommended during pregnancy. Contraindicated during lactation as it may suppress lactation and cause serious adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to tamoxifen or any component of the formulation.
- Concomitant anastrozole use.
- Women requiring coumarin-type anticoagulant therapy or with a history of deep vein thrombosis or pulmonary embolism (for risk reduction indication).
Drug Interactions
Warfarin
Increased anticoagulant effect; monitor INR closely.
Anastrozole
Concomitant use is contraindicated.
CYP3A4 inducers/inhibitors
May alter tamoxifen levels.
SSRIs (e.g., Paroxetine, Fluoxetine)
May decrease tamoxifen's effectiveness due to CYP2D6 inhibition; consider alternative antidepressants.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include exaggeration of known adverse effects like neurotoxicity (tremor, hyperreflexia, unsteady gait), prolongation of QT interval. Management is supportive, including monitoring vital signs and ECG.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Not recommended during pregnancy. Contraindicated during lactation as it may suppress lactation and cause serious adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA (for Tamoxifen)
Patent Status
Generic available (original patent expired)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established tamoxifen's efficacy and safety in various breast cancer settings, including adjuvant, metastatic, and chemoprevention trials. Ongoing research explores its role in newer therapeutic combinations and long-term outcomes.
Lab Monitoring
- Complete Blood Count (CBC)
- Liver function tests (LFTs)
- Serum calcium
- Ophthalmological exams (periodically)
- Gynecological exams (for endometrial changes)
- INR (if on warfarin)
Doctor Notes
- Advise patients about the risk of endometrial cancer and blood clots.
- Counsel on the importance of adherence to long-term therapy.
- Consider CYP2D6 genotyping for patients with poor response, although routine testing is not universally recommended.
Patient Guidelines
- Take 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).
- Have regular gynecological and ophthalmological check-ups.
- Use effective non-hormonal contraception during treatment and for two months after stopping.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause visual disturbances, dizziness, or fatigue. Exercise caution when driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity.
- Avoid smoking and excessive alcohol consumption.
- Discuss bone health and calcium intake with your doctor.
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