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 10 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Tamoral 10 mg Tablet contains Tamoxifen Citrate, a selective estrogen receptor modulator (SERM) used primarily in the treatment and prevention of breast cancer. It works by blocking the effects of estrogen in breast tissue, which can promote cancer growth.
Uses & Indications
Dosage
Adults
Usually 20 mg to 40 mg daily, taken as a single dose or in two divided doses. For breast cancer prevention, 20 mg daily for 5 years.
Elderly
No specific dosage adjustment required, but caution is advised due to potential age-related organ function decline.
Renal_impairment
No specific dosage adjustment recommended, but use with caution due to potential accumulation of metabolites.
How to Take
Take orally, with or without food, usually once or twice daily. Swallow the tablet whole with water. Do not chew or crush.
Mechanism of Action
Tamoxifen acts as an anti-estrogen by competitively binding to estrogen receptors on tumor cells and other target tissues, preventing estrogen from binding. In breast cancer cells that are estrogen receptor-positive (ER+), this blockade inhibits estrogen-induced proliferation.
Pharmacokinetics
Onset
Therapeutic effects may take several weeks to months to become apparent.
Excretion
Primarily excreted in feces, with a small amount excreted in urine.
Half life
Approximately 5-7 days for tamoxifen and 14 days for its active metabolite, N-desmethyltamoxifen.
Absorption
Well absorbed after oral administration, peak plasma concentrations reached within 4-7 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4 and CYP2D6, into several active metabolites including 4-hydroxytamoxifen and N-desmethyltamoxifen.
Side Effects
Contraindications
- Known hypersensitivity to tamoxifen or any component of the formulation.
- Concomitant coumarin-type anticoagulant therapy (for risk reduction setting).
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) (for risk reduction setting).
Drug Interactions
Warfarin
Increased anticoagulant effect, leading to an increased risk of bleeding. Close monitoring of INR is required.
Aromatase inhibitors (e.g., Anastrozole)
Do not use concomitantly with tamoxifen for adjuvant treatment as efficacy may be compromised.
CYP2D6 inhibitors (e.g., Paroxetine, Fluoxetine)
May reduce plasma levels of the active metabolite, endoxifen, potentially decreasing tamoxifen efficacy. Avoid co-administration if possible.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are not well established, but may include neurotoxicity (tremor, hyperreflexia, unsteady gait). There is no specific antidote; treatment is symptomatic and supportive.
Pregnancy & Lactation
Tamoxifen is classified as Pregnancy Category D. It can cause fetal harm and should not be used during pregnancy. It is unknown if tamoxifen is excreted in human milk, but due to potential serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug.
Side Effects
Contraindications
- Known hypersensitivity to tamoxifen or any component of the formulation.
- Concomitant coumarin-type anticoagulant therapy (for risk reduction setting).
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) (for risk reduction setting).
Drug Interactions
Warfarin
Increased anticoagulant effect, leading to an increased risk of bleeding. Close monitoring of INR is required.
Aromatase inhibitors (e.g., Anastrozole)
Do not use concomitantly with tamoxifen for adjuvant treatment as efficacy may be compromised.
CYP2D6 inhibitors (e.g., Paroxetine, Fluoxetine)
May reduce plasma levels of the active metabolite, endoxifen, potentially decreasing tamoxifen efficacy. Avoid co-administration if possible.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are not well established, but may include neurotoxicity (tremor, hyperreflexia, unsteady gait). There is no specific antidote; treatment is symptomatic and supportive.
Pregnancy & Lactation
Tamoxifen is classified as Pregnancy Category D. It can cause fetal harm and should not be used during pregnancy. It is unknown if tamoxifen is excreted in human milk, but due to potential serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established tamoxifen's efficacy in adjuvant and metastatic breast cancer. Ongoing trials explore its role in prevention and new combinations.
Lab Monitoring
- Complete blood count (CBC)
- Liver function tests (LFTs)
- Serum calcium levels
- Regular gynecological exams for endometrial changes
Doctor Notes
- Counsel patients on potential risks of endometrial cancer, VTE, and stroke.
- Monitor bone mineral density in premenopausal women.
- Consider CYP2D6 genotyping, especially if poor response is observed.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Report any unusual vaginal bleeding or discharge, pelvic pain, or changes in vision immediately.
- Discuss any planned surgery or prolonged immobilization with your doctor as it may increase the risk of blood clots.
- Regular follow-up appointments and screenings (e.g., mammograms, gynecological exams) are crucial.
Missed Dose Advice
If you miss a dose, 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 double the dose.
Driving Precautions
Tamoxifen may cause fatigue or visual disturbances. Patients should be cautioned about driving or operating machinery if they experience these effects.
Lifestyle Advice
- Maintain a healthy weight and diet.
- Engage in regular physical activity to reduce risk of blood clots and improve overall health.
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