Femzole
Generic Name
Letrozole
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
femzole 25 mg tablet | ৳ 40.00 | ৳ 200.00 |
Description
Overview of the medicine
Femzole 2.5 mg Tablet contains Letrozole, a non-steroidal aromatase inhibitor used primarily in the treatment of hormone receptor-positive breast cancer in postmenopausal women. It works by reducing the amount of estrogen produced by the body.
Uses & Indications
Dosage
Adults
The recommended dose is 2.5 mg once daily, taken orally.
Elderly
No dose adjustment is required for elderly patients.
Renal_impairment
No dose adjustment is required in patients with mild to moderate renal impairment. Data are insufficient for severe renal impairment.
How to Take
Femzole 2.5 mg Tablet should be taken orally, with or without food, at approximately the same time each day.
Mechanism of Action
Letrozole selectively inhibits the aromatase enzyme, which is responsible for converting androgens into estrogens. By inhibiting aromatase, it significantly lowers circulating estrogen levels, thereby blocking the growth-promoting effects of estrogen on hormone-sensitive breast cancer cells.
Pharmacokinetics
Onset
Within 2 days (for significant estrogen suppression).
Excretion
Mainly renal (about 90% of a dose excreted in urine, 75% as metabolites, 6% as unchanged drug); fecal excretion is minor.
Half life
Approximately 2 days (48 hours).
Absorption
Rapidly and completely absorbed from the gastrointestinal tract; absolute bioavailability is approximately 99.9%.
Metabolism
Primarily hepatic, via CYP2A6 and CYP3A4, to an inactive carbinol metabolite.
Side Effects
Contraindications
- Hypersensitivity to letrozole or any of its excipients.
- Premenopausal endocrine status.
- Pregnancy and lactation.
Drug Interactions
Tamoxifen
Concurrent use with tamoxifen is not recommended as it may reduce letrozole levels.
CYP3A4 inhibitors/inducers
Use with caution; may alter letrozole plasma concentrations.
Estrogen-containing medications
Avoid concurrent use as estrogens negate the pharmacological effects of letrozole.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote to letrozole. In case of overdose, general supportive measures should be employed. Symptomatic treatment is recommended.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment and for at least 3 weeks after the last dose.
Side Effects
Contraindications
- Hypersensitivity to letrozole or any of its excipients.
- Premenopausal endocrine status.
- Pregnancy and lactation.
Drug Interactions
Tamoxifen
Concurrent use with tamoxifen is not recommended as it may reduce letrozole levels.
CYP3A4 inhibitors/inducers
Use with caution; may alter letrozole plasma concentrations.
Estrogen-containing medications
Avoid concurrent use as estrogens negate the pharmacological effects of letrozole.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote to letrozole. In case of overdose, general supportive measures should be employed. Symptomatic treatment is recommended.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment and for at least 3 weeks after the last dose.
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 and DGDA
Patent Status
Generic versions available, original patent expired
WHO Essential Medicine
YesClinical Trials
Letrozole has been extensively studied in numerous clinical trials, including the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial and BIG 1-98 trial, demonstrating superior efficacy over tamoxifen in certain breast cancer settings.
Lab Monitoring
- Bone mineral density (BMD) monitoring due to risk of osteoporosis.
- Serum cholesterol levels.
- Liver function tests periodically.
Doctor Notes
- Monitor bone mineral density regularly. Consider bisphosphonates if osteoporosis develops.
- Assess cardiovascular risk factors before and during treatment.
- Advise patients about potential joint pain and strategies for management.
Patient Guidelines
- Take the tablet at the same time each day.
- Do not stop treatment without consulting your doctor.
- Report any unusual symptoms or severe side effects to your doctor immediately.
- Consider calcium and vitamin D supplementation for bone health, 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 resume your usual dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
Femzole may cause fatigue, dizziness, or drowsiness. Patients should be cautioned against driving or operating machinery if they experience these symptoms.
Lifestyle Advice
- Engage in regular weight-bearing exercise to help maintain bone density.
- Maintain a healthy diet rich in calcium and vitamin D.
- Avoid smoking and excessive alcohol consumption.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.