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Estradiol transdermal spray

Updated 2 Feb 2023 | Oestrogens and HRT


Transdermal spray containing estradiol.

Drugs List

  • estradiol 1.53mg/dose transdermal spray
  • LENZETTO 1.53mg/dose transdermal spray
  • Therapeutic Indications


    Replacement therapy for oestrogen deficiency symptoms

    Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women (in women at least 6 months since last menses or surgical menopause with or without uterus).


    For initiation and continuation of hormone replacement therapy, the lowest effective dose for the shortest duration should be used.


    Starting dose: One metered-dose spray daily.

    Maximum dose: Three metered-dose spray daily.

    Dose increase should only be made after at least four weeks of continuous treatment.

    In a continuous sequential dosing scheme, the progestagen is added for at least 12 to 14 days of every 28-day cycle, sequentially.

    Additional Dosage Information

    Missed doses
    Administer missed dose as soon as possible, if it is almost time for the next dose, only one dose should be taken.

    One primer spray with the cover on is required for one or more missed doses.


    Abnormal liver function test
    Acute hepatic disorder
    Breast cancer
    Deep vein thrombosis
    History of breast cancer
    History of hormone dependent neoplasm
    History of thromboembolic disorder
    Hormone dependent neoplasm
    Myocardial infarction
    Pulmonary embolism
    Thromboembolic disorder
    Thrombophilic disorder
    Uncontrolled endometrial hyperplasia
    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Family history of breast cancer
    Patients over 65 years
    Predisposition to thromboembolic disease
    Prolonged immobilisation
    Recent surgery
    Recent trauma
    Severe headache
    Abnormal mammography
    Cardiac impairment
    Diabetes mellitus
    Epileptic disorder
    Hepatic adenoma
    Hepatic disorder
    Hereditary angioneurotic oedema
    History of chloasma
    History of endometrial hyperplasia
    History of endometriosis
    Renal impairment
    Uterine fibroids

    Risk of pancreatitis in individuals with hypertriglyceridaemia
    Add progestogen for 12-14 days each cycle for those with an intact uterus
    Assess family medical history prior to commencing treatment
    Exclude breast cancer before treatment
    Exclude oestrogen dependent neoplasm before treatment
    Do breast & pelvic exam. before & during treatment if clinically indicated
    Exclude pregnancy prior to initiation of treatment
    Abnormal and/or irregular bleeding should be investigated
    Advise patients of risks/benefits & review need for treatment regularly
    Discontinue treatment if patient develops seizures
    Monitor hepatic function in patients with history of hepatic disease
    Advise patient of thromboembolic symptoms and to report them if they occur
    Advise patient that changes in their breasts should be reported to Dr/nurse
    Avoid immobilisation-treatment may cause increased risk of thromboembolism
    Discontinue at the onset of severe depression
    Increased risk of VTE during travel involving >5hr immobilisation
    Uterine fibroids may increase in size
    May interfere with certain laboratory measurements
    Discontinue 4 - 6 weeks before major surgery
    Advise patient to seek advice at first indications of pregnancy
    Discontinue at first signs of jaundice
    Discontinue at first signs of thrombophlebitis or thromboembolism
    Discontinue if cholestasis develops
    Discontinue if first appearance of migraine or severe or frequent headache
    Discontinue if first occurrence or worsening of visual disturbances
    Discontinue if headache with sudden partial/complete vision loss occurs
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Discontinue if liver function deteriorates
    Discontinue if significant rise in blood pressure occurs
    Discontinue if sudden pain in the chest occurs
    Discontinue if sudden, severe pain in stomach occurs
    Discontinue if symptoms due to endometriosis are exacerbated
    Advise patient not to take St John's wort concurrently
    Advise patient of increased risk of breast cancer vs benefits of HRT
    Advise patient to avoid exposure of application site for at least 1 hour
    Advise patient to avoid washing application site for at least 1 hour
    Use of sunscreen within 1 hour of application may reduce drug absorption

    Hormone replacement therapy (HRT) should only be considered for patients whose symptoms adversely affect quality of life. An annual careful appraisal of the risks and benefits should be undertaken. When carrying out initial medical examinations of patients, ensure that investigations (including appropriate imaging tools, e.g. mammography) are carried out in accordance with currently accepted screening practices.

    During the first months of treatment, break-through bleeding and spotting may occur. If break-through bleeding or spotting appears after the first few months, or continues after treatment has been discontinued, the reason should be investigated. This may include endometrial biopsy to exclude endometrial malignancy.

    Studies have shown an increased risk of developing breast cancer in women taking oestrogen-progesterone HRT, which usually becomes apparent after 3 years of therapy. The risk of breast cancer returns to normal after about 5 years of stopping treatment.

    Evidence suggests a slight increased risk of ovarian cancer in women taking oestrogen-only or combined oestrogen and progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.

    HRT is associated with a 1.3 to 3 fold risk of developing venous thromboembolism. The occurrence of such an event is most likely during the first year of HRT.

    There is a 1.5 fold increase in risk of ischaemic stroke in patients receiving combined oestrogen-progestogen and oestrogen-only therapy. The relative risk does not change with age or time since menopause.

    In women who start using continuous combined or oestrogen-only HRT after the age of 65, some studies have shown an increased risk of probable dementia.

    There is a 1.5 fold increase in risk of ischaemic stroke in patients receiving combined oestrogen-progestogen and oestrogen-only therapy. The relative risk does not change with age or time since menopause.

    Avoid contact of the treated area with children, if contact has been made, soap and water should be used to wash the contacted area.

    Avoid contact of the treated area with pets, a veterinarian should be contacted if pets exhibits mammary/nipple enlargement and/or vulvar swelling.

    Pregnancy and Lactation


    Estradiol is contraindicated during pregnancy.

    The manufacturer advises that treatment should be withdrawn immediately if pregnancy occurs. Studies associated with inadvertent foetal exposure to oestrogens indicate no teratogenic or foetoxic effect.


    Estradiol is contraindicated during breastfeeding.

    The manufacturer does not recommend the use of estradiol spray during breastfeeding.


    The container should be held upright and vertical for spraying and before its first use the applicator should be primed by spraying three times into the cover.

    Advise patient to use estradiol transdermal spray with caution in extreme temperature conditions such as sun bathing or sauna.

    Advise patient to avoid washing application site for at least 1 hour after dose.

    Advise patient to avoid exposure of application site for at least 1 hour after dose.

    Advise patient to discontinue treatment and consult their doctor if they suspect pregnancy.

    Advise patients not to self-medicate with St John's Wort during treatment with HRT.

    Advise patients to contact their doctor if they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).

    Encourage patients to participate in the national breast cancer screening programme and the national cervical cancer screening programme as appropriate for their age. Breast awareness should also be encouraged and patients advised to report any changes in their breasts to their doctor or nurse.

    Side Effects

    "Spotting" bleeding
    Abdominal pain
    Axillary pain
    Breast enlargement
    Breast pain
    Breast tenderness
    Cervical polyp
    Changes in libido
    Endometrial hyperplasia
    Erythema nodosum
    Gamma glutamyl transferase (GGT) increased
    Intolerance to contact lenses
    Muscle spasm
    Ovarian cysts
    Premenstrual-like syndrome
    Skin discolouration
    Skin irritation
    Vaginal bleeding
    Visual disturbances
    Weight changes

    Effects on Laboratory Tests

    Hormone replacement therapy, especially oestrogen-progestogen combined treatment may increase the density of mammographic images and adversely effect the detection of breast cancer.

    The use of oestrogen may influence the laboratory results of certain endocrine tests and their enzymes.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: May 2020

    Reference Sources

    Summary of Product Characteristics: Lenzetto 1.53 mg/spray, transdermal spray, solution. Geodeon Rickter (UK) Ltd. Revised September 2022.

    NICE Evidence Services Available at: Last accessed: 12 May 2020

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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