1. What is ESTRADOT and What Is
It Used For?
ESTRADOT is a matrix-type transdermal patch that delivers
estradiol (the principal endogenous oestrogen) continuously through the skin
into the systemic circulation, bypassing first-pass hepatic metabolism. It
delivers 25 mcg of estradiol per 24 hours.
ESTRADOT is indicated for hormone replacement therapy (HRT)
in women with menopausal symptoms — primarily vasomotor symptoms (hot flushes,
night sweats), but also vaginal atrophy, urogenital symptoms, and prevention of
osteoporosis in postmenopausal women at increased risk when other agents are
not suitable.
Transdermal oestrogen has an important advantage over oral
oestrogen: it avoids the first-pass hepatic effect, resulting in lower
triglyceride stimulation, lower C-reactive protein induction, and a lower risk
of venous thromboembolism (VTE) compared to oral oestrogen preparations. Women
with intact uteri must receive progestogen alongside oestrogen therapy to
protect the endometrium from hyperplasia.
2. How to Take This Medicine
Apply one ESTRADOT 25 mcg patch to clean, dry, intact skin
twice weekly (every 3–4 days). A 4-week supply consists of 8 patches.
Application
Sites
• Apply to hairless,
non-irritated skin on the lower abdomen, buttocks, or upper thighs.
• Do not apply to
breasts, face, or damaged/irritated skin.
• Rotate sites — do not
apply to the same skin area within 7 days.
Application
Technique
• Remove old patch. Fold
it in half (sticky sides together) and dispose of it safely.
• Open the sachet and
peel off the protective liner from the new patch.
• Press the patch firmly
onto skin with the palm for approximately 30 seconds, ensuring good adhesion
around the edges.
• If the patch partly
lifts, press it back down. If it falls off completely, apply a new patch for
the remainder of the period.
Progestogen
Requirement
Women with an intact uterus must combine ESTRADOT with a
progestogen to prevent oestrogen-induced endometrial hyperplasia and carcinoma.
Progestogen can be given as part of a combined patch (see Evorel Conti/Sequi)
or as a separate oral preparation. Women who have had a hysterectomy may use
oestrogen alone.
3. Side Effects
Common
Side Effects
• Application site
reactions: erythema, pruritus, contact dermatitis, skin irritation. Rotation of
sites reduces this.
• Breast tenderness or
enlargement.
• Irregular vaginal
bleeding or spotting (especially in the first 3 months).
• Nausea, abdominal
bloating, headache.
• Weight changes.
• Leg cramps.
Serious
Risks (Long-term HRT Use)
• Breast cancer — risk
increases with duration of use, particularly combined HRT. The absolute risk
for oestrogen-alone HRT is lower.
• Venous thromboembolism
(DVT, PE) — lower risk with transdermal vs oral route.
• Stroke — particularly
with oral oestrogen; the transdermal route has lower stroke risk.
• Endometrial cancer — if
oestrogen is used without progestogen in women with an intact uterus.
4. Contraindications — Who
Should NOT Take This Medicine
|
Do not use ESTRADOT if: •
You have known, suspected, or past history of breast
cancer. •
You have known or suspected oestrogen-dependent cancers
(e.g., endometrial cancer). •
You have unexplained genital bleeding. •
You have untreated endometrial hyperplasia. •
You have active or recent arterial thromboembolic disease
(angina, myocardial infarction, stroke). •
You have acute or severe chronic liver disease or a
history of liver disease where liver function has not normalised. •
You have active venous thromboembolism (DVT or PE) or a
predisposing thrombophilic disorder (e.g., protein C/S deficiency, Factor V
Leiden — not taking anticoagulants). •
You are allergic to estradiol or any patch component. •
You are pregnant or breastfeeding. |
5. Safety Warnings and Special
Precautions
Breast
Cancer Risk Counselling
All women should be counselled about the relationship
between HRT and breast cancer risk before starting therapy. The absolute
increase in risk from oestrogen-only HRT is small (approximately 1 extra case
per 1000 women over 5 years). Combined oestrogen-progestogen HRT carries a
higher risk. Regular breast examination and mammography as per national
guidelines must be maintained during HRT.
Duration
of Use
HRT should be used at the lowest effective dose for the
shortest time needed to control menopausal symptoms. The benefit-risk balance
should be reassessed at least annually, taking into account the woman's
individual risk factors and the severity of ongoing symptoms.
VTE
Risk
Transdermal oestrogen has a substantially lower VTE risk
than oral oestrogen. This is the preferred route in women with elevated
baseline VTE risk (overweight/obese, varicose veins, personal/family history of
VTE). However, women with established thrombophilia or past VTE should be
evaluated by a haematologist before starting any HRT.
Undiagnosed
Bleeding
Any irregular or unexpected vaginal bleeding in a
postmenopausal woman must be investigated (endometrial biopsy/transvaginal
ultrasound) to exclude endometrial pathology before starting or continuing HRT.
6. Drug Interactions
• CYP3A4 inducers
(rifampicin, phenytoin, carbamazepine, St John's Wort) — increase estradiol
metabolism and reduce plasma levels; HRT may become less effective.
• Antifungals
(ketoconazole, itraconazole) and other CYP3A4 inhibitors — may increase
estradiol levels.
• Thyroid hormone
replacement — oestrogen increases thyroid-binding globulin; women on
levothyroxine may need increased doses.
• Anticoagulants
(warfarin) — oestrogen may alter anticoagulant requirements; monitor INR.
• Antidiabetic agents —
oestrogen may impair glucose tolerance; monitor glycaemic control.
7. Storage Instructions
• Store below 25 degrees
Celsius. Do not freeze.
• Store in the original
sealed sachet until use.
• Used patches retain
some active drug — fold sticky sides together before discarding safely in
household waste (not flushed or composted — environmental oestrogen risk).
• Keep out of reach of
children.
8. Prescription Status in Kenya
ESTRADOT is a prescription-only medicine (POM) in Kenya. It
is prescribed by gynaecologists, endocrinologists, or general practitioners
managing menopausal women.
Annual review of HRT indication, dose, and risk-benefit
balance is standard practice. Prescriptions should not be renewed indefinitely
without a clinical review.
9. Patient Guidance
|
Important Reminders for Patients •
Apply a new patch twice a week at the same days — e.g.,
every Monday and Thursday. •
Rotate application sites — use a different area each time
to reduce skin irritation. •
If you have not had a hysterectomy, you must also take a
progestogen to protect your womb lining — do not use oestrogen-only therapy
without medical advice. •
Attend regular breast examinations and mammography as
recommended by your doctor. •
Contact your doctor if you experience unusual vaginal
bleeding, breast lumps, leg pain, or chest pain. •
Review your HRT with your doctor at least once a year —
the lowest effective dose for the shortest necessary time is the goal. |
10. Pharmacist / Prescriber
Notes
Prescribing
Decision Framework
The ESTRADOT 25 mcg patch is a low-dose starting option.
Higher doses (37.5 mcg, 50 mcg, 75 mcg, 100 mcg) are available for women with
inadequate symptom control. Start at 25 mcg for 4 weeks and reassess symptom
control. Increase to 50 mcg if 25 mcg is insufficient.
Progestogen
Co-prescription (Intact Uterus)
Continuous combined HRT (oestrogen + progestogen every
day): consider Evorel Conti or add continuous oral progestogen. Cyclical HRT
(progestogen added for 12–14 days per month): produces a monthly withdrawal
bleed — use Evorel Sequi or separate oral progestogen. Cyclic regimens are
preferred in perimenopause (still having periods). Continuous combined is more
convenient and preferred in established postmenopause (12 months since last
period).
Annual
Review Checklist
At annual HRT review: assess ongoing vasomotor symptom
control; review cardiovascular, breast cancer, VTE risk factors; blood
pressure; breast examination; update mammography referral; reassess duration
and dosing; discuss trial of dose reduction or cessation if symptoms improving.
11. Frequently Asked Questions
(FAQs)
Why is a patch better than an oestrogen tablet?
The ESTRADOT patch delivers oestrogen directly into the
bloodstream through the skin, bypassing the liver. Oral oestrogen tablets go
through the liver first, which stimulates clotting proteins and increases the
risk of blood clots (deep vein thrombosis and pulmonary embolism). The
transdermal patch avoids this, making it a safer option for women with
increased blood clot risk. It also avoids stomach upset and provides more
stable hormone levels.
Do I need to use the patch and a separate progestogen
tablet?
Yes, if you still have your uterus (womb). Oestrogen on its
own thickens the womb lining and can increase the risk of womb cancer. Taking a
progestogen alongside the oestrogen protects the womb lining. Women who have
had a hysterectomy can safely use oestrogen patches without any progestogen.
What should I do if the patch falls off?
If the patch comes off within the first 24 hours, try
re-applying it. If it no longer sticks, apply a new patch immediately and
change it on your usual scheduled day. If the patch comes off after 24 hours,
apply a new one and continue on your normal twice-weekly schedule. Contact your
doctor or pharmacist if patches regularly fail to stick.
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