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Brand Name: ORGAMED
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Generic Name: Estradiol Hemihydrate
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Therapeutic Class: Transdermal Estrogen Therapy
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Delivery System: Matrix-type patch (adhesive layer contains active drug)
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Available Strengths:
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25 μg/day (7.6 mg estradiol)
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50 μg/day (15.2 mg estradiol)
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75 μg/day (22.8 mg estradiol)
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100 μg/day (30.4 mg estradiol)
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2. COMPOSITION
Component | Function |
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Estradiol Hemihydrate | Active ingredient |
Polyacrylate adhesive | Matrix carrier |
Polyester film | Backing layer |
Silicone-coated release liner | Protective layer |
(Alcohol-free formulation, suitable for sensitive skin)
3. MECHANISM OF ACTION
✔ Continuous transdermal delivery of 17β-estradiol:
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Avoids first-pass hepatic metabolism
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Maintains stable serum levels (no peaks/troughs)
✔ Therapeutic Effects: -
Relieves vasomotor symptoms (hot flashes/night sweats)
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Prevents postmenopausal bone loss
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Improves urogenital atrophy
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May enhance mood/cognitive function
4. DOSAGE & ADMINISTRATION
Standard Regimens
Clinical Scenario | Initial Dose | Maintenance Dose | Patch Change Frequency |
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Vasomotor Symptoms | 25-50 μg/day | Lowest effective dose | Twice weekly |
Osteoporosis Prevention | 50 μg/day | Long-term | Twice weekly |
With Progestin (Intact Uterus) | Add oral/transdermal progestin 12-14 days/month |
Application Guide
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Site Selection: Clean, dry skin on lower abdomen or buttock
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Rotation: Avoid same site for ≥1 week
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Adhesion: Press firmly for 10 seconds
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Water Resistance: Safe for bathing/swimming
5. INDICATIONS
✅ Moderate-to-severe menopausal symptoms
✅ Prevention of postmenopausal osteoporosis
✅ Hypoestrogenism (surgical/natural menopause)
6. STORAGE CONDITIONS
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Unopened Pouches: Below 25°C (do not refrigerate)
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After Removal from Pouch: Apply immediately
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Shelf Life: 36 months
7. KEY RECOMMENDATIONS
✔ Start therapy within 10 years of menopause for cardiovascular benefit
✔ Annual breast/endometrial monitoring (if uterus present)
✔ Consider lower doses (25 μg) for older women (>65 years)
✔ Patch-free interval not required (continuous dosing)
8. IMPORTANT SAFETY NOTES
Black Box Warnings
⚠ Endometrial Cancer:
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Unopposed estrogen increases risk 8-10 fold
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Requires progestin co-therapy in non-hysterectomized women
⚠ Cardiovascular Risks:
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Lower than oral estrogens but still present
⚠ Dementia Risk: Increased in women >65 years
Contraindications
❌ Active arterial thromboembolism
❌ Estrogen-sensitive malignancies
❌ Severe hepatic impairment
Adverse Effects
Local (≥5%) | Systemic (<5%) |
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Skin irritation | Breast tenderness |
Pruritus | Headache |
Erythema | Fluid retention |
9. COMPARISON WITH OTHER HRT FORMULATIONS
Parameter | ORGAMED Patch | Oral Estradiol | Vaginal Estrogen |
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VTE Risk | + | +++ | + |
Hepatic Impact | Minimal | Significant | Minimal |
Dosing Frequency | 2x weekly | Daily | 2-3x weekly |
Libido Effect | Neutral | Neutral | Local benefit |
10. PATIENT COUNSELING POINTS
✔ Proper application technique:
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Avoid breasts/waistline areas
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Remove old patch before applying new
✔ Warning signs requiring medical attention:
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Severe skin reactions
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New breast lumps
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Visual disturbances
✔ Advantages over oral therapy:
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Lower stroke risk
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No triglyceride elevation
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Better for hypertension patients
CONCLUSION
ORGAMED provides stable, physiologic estrogen replacement with improved safety profile versus oral HRT. Its twice-weekly dosing and lower thrombotic risk make it preferable for many menopausal women, especially those with cardiovascular risk factors.
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