Zoleta
Generic Name
Letrozole
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zoleta 25 mg tablet | ৳ 43.00 | ৳ 215.00 |
Description
Overview of the medicine
Zoleta 2.5 mg tablet contains Letrozole, a non-steroidal aromatase inhibitor, primarily used for the treatment of hormone receptor-positive breast cancer in postmenopausal women.
Uses & Indications
Dosage
Adults
The recommended dose is 2.5 mg orally once daily. Treatment should continue until tumor progression or for a maximum of 5 years in adjuvant/extended adjuvant settings.
Elderly
No dosage adjustment is necessary for elderly patients.
Renal_impairment
No dosage adjustment is necessary for patients with mild to moderate renal impairment. Caution is advised in severe renal impairment (creatinine clearance < 10 mL/min).
Hepatic_impairment
No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. A 50% dose reduction (2.5 mg every other day) may be considered for severe hepatic impairment (Child-Pugh Class C).
How to Take
Zoleta 2.5 mg tablet should be taken orally once daily, at approximately the same time each day, with or without food.
Mechanism of Action
Letrozole selectively inhibits the aromatase enzyme, which is responsible for converting androgen precursors to estrogens. By reducing estrogen levels, it inhibits the growth of estrogen-dependent breast cancer cells.
Pharmacokinetics
Onset
Steady-state plasma concentrations are achieved within 2-6 weeks of daily dosing.
Excretion
Excreted mainly via the kidneys (approximately 90%) as metabolites, with a small amount excreted unchanged in the urine and feces.
Half life
Approximately 2 days (48 hours).
Absorption
Rapidly and completely absorbed from the gastrointestinal tract; absolute bioavailability is approximately 99.9%.
Metabolism
Primarily metabolized in the liver by cytochrome P450 isoenzymes CYP3A4 and CYP2A6 to inactive carbinol metabolite.
Side Effects
Contraindications
- Hypersensitivity to letrozole or any of its excipients.
- Premenopausal women.
- Pregnancy and lactation.
Drug Interactions
Tamoxifen
Concomitant use with tamoxifen is not recommended as it may reduce letrozole plasma concentrations.
Estrogen-containing medications
Avoid concomitant use as they may counteract the pharmacological action of letrozole.
CYP3A4/CYP2A6 inhibitors/inducers
Drugs affecting CYP3A4 or CYP2A6 may alter letrozole metabolism. Use with caution.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. In case of an overdose, general supportive and symptomatic care should be provided.
Pregnancy & Lactation
Zoleta is contraindicated in women who are pregnant or lactating. It can cause fetal harm. Effective contraception should be used by premenopausal women if treatment is considered.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic versions available, patent expired
Clinical Trials
Letrozole has been extensively studied in numerous randomized controlled clinical trials demonstrating its efficacy and safety in various breast cancer settings, including adjuvant, extended adjuvant, and metastatic disease.
Lab Monitoring
- Bone mineral density (BMD) before and during treatment.
- Serum cholesterol levels.
- Liver function tests (especially in patients with hepatic impairment).
Doctor Notes
- Counsel postmenopausal breast cancer patients regarding the benefits and risks, particularly bone health and cardiovascular risks.
- Monitor bone mineral density (BMD) periodically and consider bisphosphonate therapy if indicated.
- Assess lipid profile before and during treatment.
- Advise patients on lifestyle modifications to mitigate risks.
Patient Guidelines
- Take Zoleta 2.5 mg daily at the same time to maintain consistent drug levels.
- Do not stop taking this medication without consulting your doctor, even if you feel well.
- Report any unusual symptoms or side effects to your doctor immediately, especially joint pain, hot flashes, or any signs of blood clots (e.g., leg swelling, sudden chest pain).
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 with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Zoleta may cause dizziness, fatigue, or somnolence in some patients. 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 weight-bearing exercise to support bone health.
- Ensure adequate calcium and Vitamin D intake, possibly through supplements, as advised by your doctor.
- Avoid smoking and limit alcohol consumption.
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