- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Atrophic vaginitis - post-menopausal
Treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
60mg once daily at the same time each day with food.
Additional Dosage Information
If a dose is missed it should be taken with food as soon as the patient remembers. A double dose should not be taken in the same day.
Children under 18 years
Deep vein thrombosis
History of venous thromboembolism
Hormone dependent neoplasm
Retinal vein thrombosis
Severe hepatic impairment
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Body mass index above 30kg per square metre
Family history of venous thromboembolism
Predisposition to venous thromboembolism
Risk of cerebrovascular accident
CYP2C9 poor metaboliser genotype
Glucose-galactose malabsorption syndrome
History of cerebrovascular accident
Systemic lupus erythematosus
Exclude breast cancer before treatment
Exclude oestrogen dependent neoplasm before treatment
Perform a complete physical and gynaecological examination before therapy
Abnormal and/or irregular bleeding should be investigated
Advise patients of risks/benefits & review need for treatment regularly
Breakthrough bleeding should be investigated
Advise patient to contact a doctor if symptoms of thromboembolism develop
Discontinue if venous thromboembolism develops
Discontinue in the event of a prolonged period of immobilisation
Advise patient not to take St John's wort concurrently
A careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks. Ospemifene should only be continued as long as the benefit outweighs the risk.
If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy.
Due to a risk of venous thromboembolic events, ospemifene should be discontinued at least 4 to 6 weeks prior to and during prolonged immobilisation. Treatment should be resumed only after the patient is mobilised.
Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency. In some asymptomatic patients, hot flushes may occur upon beginning therapy. About 1% of subjects discontinued in the phase 2 to 3 clinical programme due to hot flushes.
Co-administration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.
Pregnancy and Lactation
Ospemifene is contraindicated during pregnancy.
Use of ospemifene is contraindicated by the manufacturer. If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn immediately. Animals studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Ospemifene is contraindicated during breastfeeding.
Use of ospemifene when breastfeeding is contraindicated by the manufacturer. Effects on exposed infants are unknown.
Subcutaneous tissue disorders
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: January 2020
Summary of Product Characteristics: Senshio 60mg film coated tablets. Shionogi. Revised November 2019.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.