- Stock: In Stock
- Brand: Square Pharmaceuticals
- Product ID: Letrozole
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| Generic Name | Letrozole |
|---|---|
| Strength | 2.5 mg |
| Dosage Form | Tablet |
| Manufacturer | Square Pharmaceuticals PLC |
| Therapeutic Class | Hormonal Chemotherapy |
| Pack Size | 2×5 (10 tablets) |
Overview
Lerozol 2.5 mg Tablet contains Letrozole, a potent and highly specific nonsteroidal aromatase inhibitor manufactured by Square Pharmaceuticals PLC. Letrozole works by competitively binding to the haem of the cytochrome P450 subunit of the aromatase enzyme, thereby inhibiting estrogen biosynthesis in all tissues. In postmenopausal women, where estrogen is derived mainly from aromatase-mediated conversion of adrenal androgens (androstenedione and testosterone) to oestrone and oestradiol, Letrozole suppresses plasma estrogen levels by up to 95%, depriving estrogen-dependent breast cancer cells of their growth stimulus.
Lerozol is indicated for: adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer; extended adjuvant treatment after 5 years of tamoxifen therapy; first-line treatment of hormone-dependent advanced breast cancer in postmenopausal women; treatment of advanced breast cancer after prior antiestrogen therapy; and pre-operative (neoadjuvant) therapy in postmenopausal women with localized hormone receptor-positive breast cancer to enable breast-conserving surgery.
Dosage and Administration
Adults and elderly: 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment should continue for 5 years or until tumour relapse, whichever comes first. In metastatic disease, treatment continues until tumour progression. No dose adjustment is required for elderly patients or for patients with mild to moderate hepatic or renal impairment (CrCl ≥10 ml/min). Patients with severe hepatic impairment (Child-Pugh C) should be closely monitored. Letrozole may be taken with or without food.
Interaction
Co-administration studies with cimetidine and warfarin showed no clinically significant drug interactions. Letrozole is metabolized by CYP3A4 and CYP2A6; strong inhibitors or inducers of these enzymes may theoretically alter Letrozole plasma concentrations. Clinical significance is limited, but patients on multiple medications should be monitored. Tamoxifen co-administration significantly reduces plasma Letrozole levels and should be avoided.
Contraindications
Lerozol is contraindicated in: known or suspected hypersensitivity to Letrozole, other aromatase inhibitors, or any formulation ingredient; pregnancy; breastfeeding; premenopausal women; and severe hepatic dysfunction (Child-Pugh C).
Side Effects
Common: Hot flushes, hypercholesterolemia, fatigue, increased sweating, arthralgia (bone and joint pain), skin rash, headache, dizziness, malaise, nausea, vomiting, indigestion, constipation, diarrhea, altered appetite, myalgia, osteoporosis/bone fractures, edema, depression, weight gain, hair loss, hypertension, abdominal pain, dry skin, vaginal bleeding, palpitations, and chest pain.
Rare: Anxiety, insomnia, drowsiness, memory problems, carpal tunnel syndrome, blurred vision, urticaria, vaginal discharge or dryness, urinary tract infection, cough, and hepatic enzyme elevation.
Pregnancy and Lactation
Letrozole is contraindicated in pregnancy. Animal studies have shown teratogenicity, embryotoxicity, and foetotoxicity at low doses. There are no adequate studies in pregnant women. It is not known whether Letrozole is excreted in human milk; it should not be administered to nursing women. Women of childbearing potential must use effective contraception during treatment.
Precautions and Warnings
Lerozol is indicated only for postmenopausal women and must not be used in premenopausal women. Bone mineral density may decrease with long-term use; patients should be monitored for osteoporosis and fracture risk, and calcium/vitamin D supplementation considered. Fatigue and dizziness have been reported — patients should be cautious when driving or operating machinery. Cholesterol levels should be monitored during treatment. In patients with severe hepatic impairment, close supervision is required. In the event of overdose, supportive treatment and vital signs monitoring are appropriate; dialysis may be helpful as the drug is weakly protein-bound.
Storage Conditions
Store below 30°C, away from light and moisture. Keep out of reach of children.
Frequently Asked Questions
Q: What is Lerozol 2.5 mg used for?
A: Lerozol 2.5 mg is an aromatase inhibitor used in the treatment and adjuvant management of hormone receptor-positive breast cancer in postmenopausal women. It is used in early breast cancer, extended adjuvant therapy after tamoxifen, advanced breast cancer, and neoadjuvant therapy before surgery.
Q: Can Lerozol be taken by premenopausal women?
A: No. Lerozol is contraindicated in premenopausal women. It is specifically indicated for postmenopausal women, either naturally or artificially postmenopausal. Use in premenopausal women is not appropriate and may be harmful.
