Tamoxi
Generic Name
Tamoxifen
Manufacturer
Beximco Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tamoxi 20 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Tamoxifen is a selective estrogen receptor modulator (SERM) used in the treatment and prevention of hormone receptor-positive breast cancer.
Uses & Indications
Dosage
Adults
Typically 20 mg once daily, or 10 mg twice daily. For breast cancer, typically taken for 5-10 years.
Elderly
No specific dose adjustment is generally required, but close monitoring for adverse effects is recommended.
Renal_impairment
No specific dose adjustment is generally needed for renal impairment, but use with caution in severe cases due to limited data.
How to Take
Administer orally, usually once daily with or without food. Tablets should be swallowed whole.
Mechanism of Action
Tamoxifen acts as an anti-estrogen by binding to estrogen receptors in breast cancer cells, thereby blocking estrogen's proliferative effects.
Pharmacokinetics
Onset
Steady-state concentrations of tamoxifen and its primary metabolite, N-desmethyltamoxifen, are reached after 3-4 weeks of continuous dosing.
Excretion
Primarily excreted in feces after hepatic metabolism and enterohepatic recirculation. Minor renal excretion.
Half life
Tamoxifen: Approximately 5-7 days. N-desmethyltamoxifen (active metabolite): Approximately 14 days.
Absorption
Well absorbed orally, peak plasma concentrations reached within 4-7 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4 and CYP2D6 enzymes, to several metabolites, including active metabolites like N-desmethyltamoxifen and 4-hydroxytamoxifen.
Side Effects
Contraindications
- Hypersensitivity to tamoxifen or any component of the formulation.
- Concomitant coumarin-type anticoagulant therapy (e.g., warfarin) for risk reduction settings.
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) for risk reduction settings.
- Severe thrombocytopenia.
Drug Interactions
Warfarin
May increase anticoagulant effect, leading to increased bleeding risk. Close monitoring of INR/PT is essential.
Rifampicin
Can significantly decrease tamoxifen plasma concentrations through induction of CYP3A4, potentially reducing efficacy.
CYP2D6 Inhibitors (e.g., paroxetine, fluoxetine)
May reduce the plasma levels of active tamoxifen metabolites, potentially decreasing efficacy. Avoid concomitant use if possible.
Aromatase Inhibitors (e.g., anastrozole, letrozole)
Concurrent use is generally not recommended as they have opposing mechanisms of action.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose experience is limited. Expected symptoms include increased severity of known side effects such as hot flashes, nausea, and CNS effects. Treatment is symptomatic and supportive; there is no specific antidote.
Pregnancy & Lactation
Pregnancy Category D. Tamoxifen can cause fetal harm. Avoid use during pregnancy. It is unknown if tamoxifen is excreted in human milk; avoid during breastfeeding due to potential for serious adverse reactions in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, consult product packaging for exact date.
Availability
Pharmacies, Hospitals
Approval Status
FDA/DGDA Approved
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Numerous large-scale clinical trials (e.g., NSABP B-14, ATLAS, aTTom) have established tamoxifen's efficacy and safety in the adjuvant and metastatic settings for breast cancer, as well as for risk reduction.
Lab Monitoring
- Complete blood count (CBC) periodically.
- Liver function tests (LFTs) periodically.
- Serum calcium levels (especially if bone metastases are present).
- Regular gynecological examinations, including endometrial evaluations, due to risk of endometrial changes.
Doctor Notes
- Counsel patients thoroughly on the potential serious risks, including endometrial cancer and thromboembolic events, and the importance of prompt reporting of symptoms.
- Consider CYP2D6 genotyping for patients who show suboptimal response or when considering alternative therapies, although routine testing is not universally recommended.
- Advise postmenopausal women to undergo regular gynecological examinations, including annual endometrial biopsy or ultrasound if indicated.
Patient Guidelines
- Take tamoxifen exactly as prescribed by your doctor.
- Report any unusual vaginal bleeding, discharge, or pelvic pain immediately.
- Seek urgent medical attention if you experience symptoms of blood clots (e.g., leg pain/swelling, chest pain, shortness of breath, sudden vision changes).
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Attend regular follow-up appointments with your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double doses.
Driving Precautions
Tamoxifen may cause fatigue or visual disturbances (e.g., blurred vision, cataracts). Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity.
- Avoid smoking, as it may increase the risk of blood clots.
- Discuss bone health and potential need for calcium/vitamin D supplements with your doctor, as tamoxifen can affect bone density in some patients.
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