Estradot

What is Estradot?

Estradot^® is a transdermal patch system containing oestradiol (also spelled estradiol), which is a bioidentical form of the primary female sex hormone oestrogen. It belongs to a class of treatments known as hormone replacement therapy (HRT), specifically designed to address the hormonal deficiency that occurs during menopause.

Active Ingredient and Drug Class

The active ingredient in Estradot is oestradiol (17β-estradiol), which is chemically identical to the oestradiol naturally produced by the ovaries. This distinguishes it from synthetic oestrogens like ethinylestradiol found in many oral contraceptives.

Mechanism of Action

Estradot works by delivering oestradiol directly through the skin into the bloodstream, bypassing the digestive system and first-pass metabolism in the liver. This transdermal delivery method provides:

• A steady, continuous release of hormone mimicking natural ovarian function
• More consistent blood levels compared to oral HRT
• Lower required doses since the hormone isn't partially metabolized by the liver
• Potentially fewer side effects related to liver metabolism

Biological Pathway Explanation

Oestradiol enters the bloodstream through the skin and binds to oestrogen receptors throughout the body. These receptors are found in various tissues including the brain, blood vessels, bones, skin, and reproductive organs. By activating these receptors, oestradiol helps to:

• Regulate body temperature control centres in the brain (reducing hot flushes)
• Maintain vaginal lubrication and elasticity
• Support bone mineral density
• Improve skin collagen content and moisture
• Modulate cholesterol metabolism

What is Estradot Used For?

Estradot is specifically approved for the short-term relief of menopausal symptoms in women with oestrogen deficiency. It is not indicated for long-term maintenance of general health or prevention of age-related conditions.

Approved Indications

• Moderate to severe vasomotor symptoms: Hot flushes, night sweats
• Urogenital atrophy symptoms: Vaginal dryness, discomfort during intercourse
• Other oestrogen-deficiency symptoms: Sleep disturbances, mood changes (when related to menopause)

Target Patient Populations

Estradot is NOT suitable for: Birth control, restoration of fertility, long-term prevention of osteoporosis (except as secondary benefit when treating menopausal symptoms), or prevention of cardiovascular disease or dementia.

Before Using Estradot

A comprehensive medical evaluation is essential before starting Estradot to ensure it's appropriate for your individual health profile. According to the NHS guidelines on oestrogen treatments, proper assessment is crucial for safe HRT use.

Medical History Assessment Checklist

Inform your doctor if you have or have had any of the following:

• Breast cancer or family history of breast cancer
• Uterine/endometrial cancer or abnormal vaginal bleeding
• Blood clots (thromboembolism) in legs, lungs, or elsewhere
• Heart disease, heart attack, or stroke
• Liver disease or severe liver problems
• High blood pressure
• Diabetes
• Migraine with aura
• Gallbladder disease
• Systemic lupus erythematosus (SLE)
• Epilepsy
• Asthma
• Endometriosis or uterine fibroids
• Thyroid disorders
• High triglyceride levels
• Hereditary angioedema
• Severe skin reactions to adhesives or oestrogens

Required Baseline Tests

• Blood pressure measurement
• Breast examination (clinical and mammogram if age-appropriate)
• Pelvic examination including Pap smear
• Liver function tests if indicated
• Lipid profile (cholesterol and triglycerides)
• Evaluation of venous thromboembolism risk factors

Pre-treatment Evaluations

Your doctor should discuss:

1. The expected benefits of treatment for your specific symptoms
2. Potential risks based on your personal and family medical history
3. The importance of using the lowest effective dose for the shortest duration
4. The need for regular monitoring (at least annual reviews)
5. Progestogen requirements if you still have your uterus

Estradot Contraindications

Absolute Contraindications (Must Not Use)

• Pregnancy or suspected pregnancy
• Breastfeeding
• Known or suspected breast cancer
• Known or suspected oestrogen-dependent neoplasia
• Active or recent arterial thromboembolic disease (e.g., angina, myocardial infarction)
• Active or recent venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism)
• Active or recent cerebrovascular disease (e.g., stroke, TIA)
• Severe hepatic disease or acute liver disease
• Undiagnosed abnormal genital bleeding
• Known hypersensitivity to oestradiol or any patch component
• Porphyria

Relative Contraindications (Use With Extreme Caution)

Special Population Considerations

Elderly Patients (≥65 years)

• Increased risk of stroke, dementia, and breast cancer with HRT use
• Generally not recommended for initiation in women over 60
• If continuing treatment, use lowest effective dose with frequent benefit-risk reassessment
• Women's Health Initiative Memory Study showed increased dementia risk in women 65-79 taking combined HRT

Renal Impairment

No dosage adjustment typically needed for mild to moderate renal impairment. Use with caution in severe renal impairment as limited data available.

Hepatic Impairment

• Mild impairment: Use with caution; monitor liver function
• Moderate to severe impairment: Contraindicated due to impaired metabolism
• Active liver disease or history of liver tumors associated with oestrogen use are absolute contraindications

Pediatric/Adolescent Patients

Not indicated for use in children or adolescents. Estradot is specifically for menopausal women experiencing oestrogen deficiency symptoms.

Estradot and Other Medicines

Several medications can interact with Estradot, either reducing its effectiveness or increasing side effects. Detailed interaction information is available in the official Estradot SMPC.

High-Risk Medication Combinations

Timing Recommendations for Other Medications

• No specific timing requirements for Estradot with most medications
• Inform all healthcare providers about your Estradot use before starting any new medication
• If taking enzyme-inducing medications, your doctor may recommend starting with a higher Estradot dose

Pregnancy & Breastfeeding

Pregnancy

• Oestrogen use during pregnancy is associated with fetal harm
• May cause feminization of male fetus
• Not indicated for pregnancy-related symptoms
• If pregnancy occurs during treatment, stop Estradot immediately

Breastfeeding

• Oestradiol passes into breast milk
• May affect milk production and quality
• Potential effects on nursing infant unknown
• Absolute contraindication during lactation

Contraception Requirements

Estradot is NOT a contraceptive. Perimenopausal women may still ovulate and should use non-hormonal contraception (barrier methods, copper IUD) if pregnancy prevention is desired.

Driving & Machine Operation

Estradot is not expected to affect the ability to drive or operate machinery. However, individual responses may vary:

• Some women may experience dizziness, especially when starting treatment
• Migraine or severe headaches (possible side effects) could impair concentration
• If you experience dizziness, visual disturbances, or drowsiness, avoid driving until symptoms resolve
• Report any concerning symptoms to your doctor

Warning signs to watch for: Dizziness, lightheadedness, visual disturbances, severe headache, or fatigue that affects alertness.

Estradot Ingredients

Active Ingredient

• Oestradiol (Estradiol): 17β-estradiol, identical to natural ovarian oestradiol

Inactive Ingredients (Excipients)

Allergen Warnings

Do not use Estradot if you have a known allergy to oestradiol or any patch component. Patch adhesives may cause contact dermatitis in sensitive individuals. Test on a small area if you have sensitive skin or history of adhesive reactions.

How to Use Estradot Patches

Proper application is essential for effective treatment and minimizing skin reactions.

Step-by-Step Application

1. Prepare the skin: Choose a clean, dry, hairless area on the lower abdomen or buttock. Avoid areas with cuts, irritation, or lotions.
2. Open the pouch: Tear open the foil pouch along the notch. Remove the patch.
3. Remove the liner: Peel off the transparent protective liner from the patch.
4. Apply the patch: Press the patch firmly onto the skin with your palm for 10-15 seconds, ensuring all edges adhere properly.
5. Check adhesion: Run your finger around the edge to ensure it's sealed.
6. Rotate sites: Change application site with each new patch to minimize skin irritation.

When to Start Treatment

• If new to HRT: Start at any convenient time
• If switching from another HRT: Follow your doctor's instructions for transition timing
• Apply first patch and change every 3-4 days (twice weekly)

Estradot Dosage Guidelines

Initial Dosage

Most women start with Estradot 50 mcg/day. Your doctor will adjust based on your response.

Titration Schedule

Progestogen Requirement

Women with a uterus (who have not had a hysterectomy) must take a progestogen alongside Estradot to protect the endometrium from hyperplasia. This can be:

• Continuous combined therapy (progestogen daily)
• Sequential therapy (progestogen for 12-14 days per month)

Administration Instructions

Patch Changing Schedule

• Apply new patch twice weekly (every 3-4 days)
• Choose consistent days (e.g., Monday morning and Thursday evening)
• Each carton contains 8 patches (4-week supply)

Application Site Rotation

To minimize skin irritation:

1. Apply to lower abdomen or buttock (upper buttock area preferred)
2. Avoid waistline areas where clothing may rub
3. Do not apply to breasts
4. Wait at least 1 week before reusing the same skin area

What to Do if Patch Falls Off

• If patch falls off, reapply if still sticky or apply a new patch
• If patch has been off for more than 24 hours, start a new patch cycle
• If problems with adhesion persist, try different application sites or discuss with your doctor

Missed Dose Management

Tips for remembering: Set phone reminders, use a calendar, or associate patch changes with regular weekly activities.

If you have trouble remembering when to change patches, ask your pharmacist for hints or consider a pill organizer with reminder notes.

Overdose Information

Symptoms of Overdose

• Nausea and vomiting
• Breast tenderness or enlargement
• Abnormal vaginal bleeding
• Fluid retention (swollen ankles, weight gain)
• Drowsiness or fatigue

Management of Overdose

1. Remove the patch immediately
2. Contact your doctor or Poison Information Centre (0800 POISON or 0800 764 766)
3. If severe symptoms develop, go to Accident & Emergency
4. Bring the medicine packaging with you to hospital

Note: Intentional overdose is unlikely with patches, but swallowing a patch may cause nausea and vomiting. Keep patches away from children and pets.

Estradot Side Effects

Like all medicines, Estradot can cause side effects, although not everyone experiences them. According to the BNF (British National Formulary), monitoring for side effects is essential during HRT treatment.

Frequency-Based Categorization

Very Common (≥1 in 10 patients)

• Application site reactions (redness, itching, irritation)
• Breast tenderness or pain
• Headache
• Abdominal pain or cramps

Common (≥1 in 100 to <1 in 10 patients)

• Nausea
• Fluid retention (swelling of ankles/fingers)
• Irregular vaginal bleeding or spotting
• Mood changes
• Weight changes
• Back pain
• Leg cramps

Uncommon (≥1 in 1,000 to <1 in 100 patients)

• Vaginal yeast infection
• Migraine
• Dizziness
• Skin discoloration at application site
• Contact dermatitis

Rare (≥1 in 10,000 to <1 in 1,000 patients)

• Gallbladder disease
• High blood pressure
• Allergic reactions
• Changes in liver function

Serious Side Effects Requiring Immediate Medical Attention

• Signs of blood clots: sudden chest pain, breathlessness, leg pain/swelling
• Signs of stroke: sudden severe headache, vision problems, weakness/numbness
• Signs of liver problems: yellow skin/eyes, dark urine, severe abdominal pain
• Severe allergic reaction: swelling of face/lips/throat, difficulty breathing

How to Store Estradot

Storage Conditions

• Store in original packaging at room temperature (15-25°C)
• Protect from light and moisture
• Do not store in bathroom or near sink
• Keep out of reach of children and pets
• Do not use after expiry date printed on packaging

Disposal Protocol

1. Fold used patch in half with adhesive sides together
2. Place in household waste where children cannot access
3. Used patches still contain active medication
4. Do not flush patches down toilet
5. Return unused/expired patches to pharmacy for disposal

Estradot Pack Information

Available Pack Sizes

• Cartons contain 8 patches (4-week supply at 2 patches per week)
• Available in four strengths: 25, 50, 75, and 100 mcg/day
• Not all strengths may be available at all pharmacies

Pack Appearance

• Rectangular patches with rounded corners
• Varying sizes depending on strength
• Individually sealed in foil pouches
• Carton includes patient information leaflet

Manufacturer Information

Manufacturer: Novartis Pharmaceuticals
Distributed in UK by: Sandoz Limited
Marketing Authorisation Holder: Novartis Europharm Limited

Where Can I Buy Estradot Online in the UK