Sandrena Gel

What is Sandrena Gel?

Sandrena Gel is a transdermal hormone replacement therapy (HRT) containing estradiol hemihydrate, which is chemically and biologically identical to the natural estrogen (17β-estradiol) produced by women's ovaries before menopause.

Drug Class and Mechanism of Action

Pharmacotherapeutic class: Natural and semisynthetic estrogens, plain (ATC code: G03CA03)

Mechanism of action: According to the official SmPC, Sandrena Gel works by replenishing declining estrogen levels during menopause. Think of it like refilling a hormone fuel tank that becomes depleted during menopause. The estradiol is absorbed through the skin directly into the bloodstream, bypassing the liver's first-pass metabolism (unlike oral HRT). This results in more stable blood levels and a more natural estradiol-to-estrone ratio (0.4-0.7 compared to less than 0.2 with oral estrogen).

Biological Pathway

After application, estradiol enters the bloodstream and binds to estrogen receptors throughout the body, particularly in:

• Hypothalamus: Helps regulate body temperature, reducing hot flushes
• Bone cells: Slows bone resorption, helping prevent osteoporosis
• Vaginal tissues: Maintains moisture and elasticity
• Skin: Supports collagen production

What is Sandrena Gel Used For?

Sandrena Gel is approved for two main indications in postmenopausal women:

Approved Indications

Target Patient Populations

• Postmenopausal women (typically age 45-65) with bothersome menopausal symptoms
• Women at high risk of osteoporotic fractures (based on bone density scans and risk factors)
• Women who prefer transdermal application over oral tablets
• Women with intact uterus require additional progestagen therapy (not needed after hysterectomy unless endometriosis history)

Before Using Sandrena Gel

Medical History Assessment Checklist

Before starting Sandrena Gel, your clinician will review:

• Personal or family history of breast cancer
• History of blood clots (venous thromboembolism)
• Liver disease or abnormal liver function
• Cardiovascular disease (heart attack, stroke, angina)
• Endometriosis or uterine fibroids
• Migraine with aura
• Gallbladder disease
• High blood pressure
• Diabetes
• Epilepsy
• Asthma
• Lipid disorders

Required Baseline Tests

• Blood pressure measurement
• Breast examination and up-to-date mammogram if age-appropriate
• Pelvic examination (for women with intact uterus)
• Liver function tests if indicated by history
• Lipid profile if cardiovascular risk factors present
• Bone mineral density scan if assessing osteoporosis risk

Pre-Treatment Evaluations

A complete personal and family medical history should be taken. Physical examination should be guided by contraindications and warnings. The benefit-risk balance should be assessed at least annually.

Sandrena Gel Contraindications

Absolute Contraindications (Must Not Use)

• Known or suspected cancer (breast cancer, estrogen-dependent malignancies, endometrial cancer)
• Thromboembolic disorders (previous or current venous thromboembolism, known thrombophilic disorders)
• Active liver disease (acute liver disease or history with abnormal liver function)
• Undiagnosed genital bleeding (any abnormal vaginal bleeding without diagnosis)
• Hypersensitivity to estradiol or any excipients in Sandrena Gel
• Porphyria (rare metabolic disorder)

Conditions Requiring Special Caution

Special Population Considerations

Elderly Patients (Over 65)

• Experience treating women over 65 is limited
• HRT should generally not be initiated in this age group for osteoporosis prevention
• If used for menopausal symptoms, use lowest effective dose and reassess regularly

Renal Impairment

• No dosage adjustment needed for mild to moderate impairment
• Patients with terminal renal insufficiency should be closely observed for fluid retention

Hepatic Impairment

• Contraindicated in active liver disease or history of liver disease with abnormal function
• Mild impairment requires monitoring

Pediatric/Adolescent Use

• Not indicated for children or adolescents
• Accidental exposure in children can cause precocious puberty or breast development

Sandrena Gel and Other Medicines

Significant interactions requiring monitoring:

High-Risk Combinations

• Enzyme Inducers: Phenobarbital, carbamazepine, rifampicin, St John's wort - may reduce estradiol effectiveness
• HCV Antivirals: Ombitasvir/paritaprevir/ritonavir + dasabuvir, glecaprevir/pibrentasvir - potential ALT elevation risk
• HIV Protease Inhibitors: Ritonavir, nelfinavir - may alter estradiol levels
• Lamotrigine: Anti-epileptic - may reduce seizure control
• Anticoagulants: Warfarin, DOACs - estrogens may affect clotting

Timing Recommendations

As a transdermal gel applied once daily, Sandrena has fewer food and timing interactions than oral medications. However:

• Apply at approximately the same time each day
• No specific food restrictions
• If taking enzyme-inducing medications, evening application may help maintain overnight hormone levels

Pregnancy & Breastfeeding

Pregnancy

• CONTRANDICATED during pregnancy
• If pregnancy occurs during treatment, discontinue Sandrena Gel immediately
• Most epidemiological studies show no teratogenic or fetotoxic effects from inadvertent fetal exposure, but HRT is not indicated during pregnancy

Breastfeeding

• CONTRANDICATED during lactation
• Sandrena Gel is not indicated while breastfeeding

Contraception Requirements

Sandrena Gel does NOT provide contraception. Postmenopausal women are unlikely to conceive, but perimenopausal women may still be fertile and should use non-hormonal contraception if pregnancy prevention is needed.

Driving & Machine Operation

• No studies specifically on driving ability have been performed with Sandrena Gel
• Potential concerns: Dizziness and visual disturbances (rare side effects) could impair driving ability
• If you experience these symptoms, do not drive or operate machinery until they resolve
• Warning signs to watch for: Dizziness, migraine, visual impairment, or drowsiness

Sandrena Gel Ingredients

Active Ingredient

• Estradiol hemihydrate - equivalent to 0.5 mg estradiol per sachet

Excipients (Inactive Ingredients)

Allergen Warnings

Sandrena Gel contains propylene glycol and ethanol. If you have known hypersensitivity to these excipients, do not use this product.

How to Use Sandrena Gel

Step-by-Step Administration

1. Choose application site: Lower trunk (below waistline) or right/left thigh. Alternate sides daily.
2. Prepare skin: Ensure skin is clean, dry, and intact (no cuts, irritation, or inflammation).
3. Open sachet: Tear open single-dose sachet at notch.
4. Apply gel: Squeeze entire contents onto palm and apply to chosen area over 1-2 hand-sized area (200-400 cm²).
5. Spread gently: Use fingers to spread gel thinly and evenly. Do not rub vigorously.
6. Let dry: Allow gel to dry completely (2-5 minutes).
7. Wash hands: Wash hands thoroughly with soap and water after application.
8. Cover area: Once dry, cover application site with clothing.

Important Do's and Don'ts

Dosage Guidelines

Starting Dose

The usual starting dose is 1.0 mg estradiol daily (1.0 g gel, 2 sachets). Starting dose may be adjusted based on symptom severity.

Titration Schedule

Osteoporosis Prevention Dose

For osteoporosis prevention: 1.5 mg estradiol daily (1.5 g gel, 3 sachets) is the minimum effective dose for most patients.

Progestagen Addition

Women with intact uterus must take a progestagen for at least 12-14 consecutive days per month to prevent endometrial hyperplasia. Not needed after hysterectomy unless endometriosis history.

Administration Instructions

Application Technique Details

Area: Apply to 1-2 hand-sized area (200-400 cm²). Larger application areas decrease absorption.

Timing: Apply once daily, preferably at same time. Can be morning or evening based on preference.

Drying time: Allow 2-5 minutes to dry completely. Do not wash application site for 1 hour after application.

Preventing Accidental Transfer

According to NHS guidelines, estradiol can transfer to others through skin contact, potentially causing adverse effects:

• Cover application site with clothing once dry
• Avoid skin-to-skin contact for at least 1 hour
• Shower before expected close contact
• Warn household members not to touch application area
• If children show breast development or other sexual changes, consult doctor immediately

Missed Dose Management

Consequences of missed doses: May increase breakthrough bleeding and spotting. Do not double dose to make up for missed dose.

Overdose Information

Overdose Symptoms

• Nausea and vomiting
• Breast tenderness
• Abdominal or pelvic swelling
• Anxiety and irritability
• Withdrawal bleeding

Management Protocol

1. Stop treatment immediately
2. Wash off any remaining gel from skin
3. Monitor for symptoms - usually resolve when treatment stops
4. Contact doctor for advice
5. No specific antidote - treatment is symptomatic

Important: Overdose is unlikely with transdermal application but possible with excessive application or accidental ingestion. Estrogens are generally well-tolerated even in high doses.

Sandrena Gel Side Effects

Frequency-Based Categorisation

Very Common (≥1/10 patients)

• Application site reactions
• Breast pain/tenderness

Common (≥1/100 to <1/10)

• General: Weight changes, increased sweating, edema
• Psychiatric: Depression, nervousness, lethargy
• Nervous system: Headache, dizziness
• Vascular: Hot flushes (during initial treatment)
• Gastrointestinal: Nausea, vomiting, abdominal pain, flatulence
• Reproductive: Unscheduled vaginal bleeding/spotting, vaginal discharge, menstrual disorders
• Skin: Rash, pruritus

Uncommon (≥1/1,000 to <1/100)

• Neoplasms: Benign breast/endometrial neoplasms
• Psychiatric: Anxiety, insomnia, libido changes
• Cardiac: Palpitations
• Vascular: Hypertension, superficial phlebitis
• Reproductive: Breast enlargement, endometrial hyperplasia

Rare (≥1/10,000 to <1/1,000)

• Vascular: Venous thromboembolism (deep vein thrombosis, pulmonary embolism)
• Hepatobiliary: Liver function alterations
• Eye: Contact lens intolerance

Long-Term Risks

• Breast cancer: Increased risk with combined estrogen-progestagen HRT after 3-5 years
• Endometrial cancer: Increased with estrogen-only therapy in women with uterus
• Ovarian cancer: Slightly increased risk
• Venous thromboembolism: 1.3-3 fold increased risk, highest in first year
• Stroke: Up to 1.5 fold increased risk of ischemic stroke

How to Store Sandrena Gel

Storage Requirements

• Temperature: Do not store above 25°C
• Location: Keep in original packaging
• Protection: Protect from light and moisture
• Out of reach: Keep out of sight and reach of children

Disposal Protocols

• Unused medicine: Return to pharmacy for safe disposal
• Used sachets: Dispose with household waste
• Environmental note: This product may pose risk to aquatic environment - do not dispose in wastewater

Shelf life: 3 years from manufacture date. Do not use after expiry date printed on packaging.

Sandrena Gel Pack Information

Available Pack Sizes

• 28 single-dose sachets - 1 month supply at 1 sachet/day
• 91 single-dose sachets - 3 month supply at 1 sachet/day

Pack Contents

• Single-dose aluminium foil sachets (PET/Aluminium/PE laminate)
• Each sachet contains 0.5 mg estradiol (as hemihydrate) in 1.0 g gel
• Patient information leaflet included

Ordering Information

Available via prescription after online consultation. Choose between 1-month or 3-month supply based on your treatment plan and doctor's recommendation.

Where Can I Buy Sandrena Gel Online in the UK