DERMESTRIL‑SEPTEM 75 µg/24 h Transdermal Patch
Hormone Replacement Therapy (HRT)
Description
Generic Name: Estradiol
Brand Name: Dermestril-Septem
Drug Class: Estrogen (transdermal hormone replacement therapy)
This is a prescription medicine, which requires a valid prescription!
Indications
- Hormone Replacement Therapy (HRT):
- Relief of moderate to severe menopausal symptoms, including hot flashes, night sweats, sleep disturbances, mood changes, and vaginal dryness.
- Prevention of postmenopausal osteoporosis in women at high risk who are intolerant to or not eligible for other bone-sparing therapies.
- Relief of moderate to severe menopausal symptoms, including hot flashes, night sweats, sleep disturbances, mood changes, and vaginal dryness.
- Intended for postmenopausal women, especially those who prefer a transdermal (patch) formulation to avoid first-pass liver metabolism.
Dermestril-Septem contains 17β-estradiol, a natural form of estrogen, delivered via the skin over 7 days:
- Estradiol binds to estrogen receptors in various tissues: brain, bones, urogenital tract, cardiovascular system.
- Alleviates vasomotor symptoms (e.g., hot flashes), improves sleep and mood, and maintains bone density.
- Transdermal delivery provides stable blood levels and bypasses liver metabolism, reducing hepatic-related side effects.
- Form: Transdermal patch
- Dose: 75 µg of estradiol released per 24 hours
- Frequency: Apply 1 patch per week (every 7 days)
- Administration Site:
- Apply to clean, dry, hairless skin on the lower abdomen or buttocks.
- Do not apply to the breasts.
- Rotate application sites; avoid the same area within 1 week.
- Women with a uterus:
- Must combine with a progestogen (e.g., dydrogesterone, medroxyprogesterone) for at least 12–14 days per cycle to reduce the risk of endometrial hyperplasia or cancer.
- Common (usually mild and gastrointestinal):
- Skin irritation or redness at the application site
- Breast tenderness
- Headache
- Nausea or bloating
- Irregular vaginal bleeding or spotting
- Mood swings
- Serious (rare):
- Venous thromboembolism (VTE): Deep vein thrombosis, pulmonary embolism
- Stroke or heart attack (particularly in older women or smokers)
- Breast cancer or endometrial cancer (risk increases with prolonged use, especially without a progestogen)
- Liver dysfunction
- Gallbladder disease
- Known or suspected estrogen-dependent tumors (e.g., breast or endometrial cancer)
- Active or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
- Undiagnosed abnormal vaginal bleeding
Information
Warnings and Precautions:
- Not for use in women with:
- Active or past breast cancer
- Unexplained vaginal bleeding
- Known or suspected estrogen-dependent tumors
- Active or history of thromboembolic disorders
- Severe liver impairment
- Monitor for:
- Breast changes or lumps
- Endometrial thickening or bleeding
- Signs of thromboembolism (leg pain, chest pain, breathlessness)
- Pregnancy & Lactation: Contraindicated
- Use lowest effective dose for the shortest duration needed to control symptoms.
Drug Interactions:
- CYP3A4 inducers (e.g., carbamazepine, rifampicin, phenytoin): May reduce estradiol levels and effectiveness
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): May increase estradiol exposure
- Thyroid hormone therapy: May require dose adjustment due to increased thyroxine-binding globulin
- Anticoagulants (e.g., warfarin): Monitor INR with concomitant use
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pharmacy@doctorworld.eu
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