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Generic Name: Letrozole
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Therapeutic Class: Aromatase inhibitor (3rd generation)
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Available Forms: 2.5 mg film-coated tablets
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Manufacturer: Various (generic versions available)
2. Composition
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Active Ingredient: Letrozole 2.5 mg
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Excipients:
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Lactose monohydrate
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Microcrystalline cellulose
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Sodium starch glycolate
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Hypromellose
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Magnesium stearate
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3. Mechanism of Action
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Reversible inhibition of aromatase enzyme
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Blocks conversion of androgens to estrogens
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Results in:
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Reduced estrogen levels (serum E2 <20 pg/mL)
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Increased FSH secretion from pituitary
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Enhanced follicular recruitment
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4. Dosage & Administration
For Fertility Treatment
Protocol | Dose | Duration | Monitoring |
---|---|---|---|
Ovulation Induction | 2.5-5 mg/day | Days 3-7 of cycle | Follicular tracking |
IVF Stimulation | 5 mg/day | Days 3-7 | E2 levels + ultrasound |
Poor Responders | 5-7.5 mg/day | Extended protocols | Intensive monitoring |
For Breast Cancer
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2.5 mg once daily (continuous)
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Duration: Until disease progression
Administration Notes
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Take with or without food
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Best taken in morning
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For fertility: precise cycle day initiation critical
5. Indications
✔ First-line ovulation induction (PCOS patients)
✔ Adjuvant therapy for hormone-receptor positive breast cancer
✔ Extended adjuvant therapy post-tamoxifen
✔ Male infertility (off-label for testosterone enhancement)
6. Storage Conditions
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Temperature: Below 30°C
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Humidity: Keep in original packaging
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Shelf Life: Typically 36 months
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Protection: Avoid moisture and light
7. Key Recommendations
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For Fertility:
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Start ultrasound monitoring on day 10
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Consider hCG trigger when lead follicle reaches 18mm
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Limit to 6 treatment cycles
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For Oncology:
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Monitor bone mineral density annually
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Assess lipid profile regularly
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Manage arthralgia with NSAIDs
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8. Important Safety Information
Warnings
⚠ Fetal toxicity (Pregnancy Category X)
⚠ Decreased bone mineral density
⚠ Increased cholesterol levels
Contraindications
❌ Pregnancy
❌ Premenopausal women without ovarian suppression
❌ Severe hepatic impairment
Adverse Effects
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Common:
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Hot flashes (20%)
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Fatigue (15%)
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Arthralgia (12%)
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Serious:
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Osteoporosis (long-term use)
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Cardiovascular events
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Depression
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9. Comparison with Other Fertility Agents
Parameter | PRIMIGYN | Clomiphene | Gonadotropins |
---|---|---|---|
Pregnancy Rate | 25-30% | 15-20% | 20-25% |
Multiple Pregnancy | 3-5% | 5-8% | 15-30% |
Cycle Control | Good | Moderate | Requires intensive monitoring |
Cost per Cycle | $ | $ | $$$ |
10. Patient Counseling Points
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For fertility patients:
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Use barrier contraception during treatment
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Report severe pelvic pain immediately
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Understand timing for intercourse/IUI
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For cancer patients:
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Importance of calcium/vitamin D supplementation
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Regular exercise for bone health
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Management of menopausal symptoms
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11. Regulatory Status
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FDA Approved:
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Breast cancer (1997)
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Off-label for fertility
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Pregnancy Category: X
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Prescription Requirements: Mandatory
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