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Prasterone vaginal


Vaginal pessaries containing prasterone.

Drugs List

  • INTRAROSA 6.5mg pessary
  • prasterone 6.5mg pessary
  • Therapeutic Indications


    Atrophic vaginitis - post-menopausal



    1 pessary to be inserted once daily at bedtime.

    Additional Dosage Information

    If a dose is missed, it should be inserted as soon as the patient remembers unless the next dose is due in less than 8 hours, in which case the missed pessary should be inserted when the next dose is due. Do not insert 2 pessaries to make up for a missed dose.


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

    Precautions and Warnings

    Family history of breast cancer
    Major surgery
    Predisposition to thromboembolic disease
    Prolonged immobilisation
    Severe headache
    Cardiac impairment
    Diabetes mellitus
    Endometrial hyperplasia
    Epileptic disorder
    Hepatic adenoma
    Hepatic disorder
    History of endometrial hyperplasia
    Ovarian carcinoma
    Renal impairment
    Systemic lupus erythematosus
    Uterine fibroids

    Assess family medical history prior to commencing treatment
    Exclude breast cancer before treatment
    Exclude oestrogen dependent neoplasm before treatment
    Treat vaginal infections before initiation of therapy
    Do breast & pelvic exam. before & during treatment if clinically indicated
    Monitor blood pressure pre-treatment and periodically thereafter
    Abnormal and/or irregular bleeding should be investigated
    Advise patients of risks/benefits & review need for treatment regularly
    Review treatment every 6 months
    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 4 - 6 weeks before major surgery
    Discontinue at first signs of jaundice
    Discontinue at first signs of thrombophlebitis or thromboembolism
    Discontinue if first occurrence or worsening of migraine/severe headache
    Discontinue if liver function deteriorates
    Discontinue if significant rise in blood pressure occurs
    Discontinue if sudden pain in the chest occurs
    Pregnancy confirmed: Discontinue this medication
    Male & female: Damages latex condoms and diaphragms
    Advise women to participate in breast/cervical cancer screening programmes

    Pregnancy and Lactation


    Prasterone pessary is contraindicated during pregnancy.

    The manufacturer notes that if pregnancy occurs during treatment with this medication, the treatment should be stopped immediately. The potential risk in humans is unknown.

    There is little data on the use on this medication in pregnant women and no studies in animals were performed with regard to the reproductive toxicity.


    Prasterone pessary is contraindicated during breastfeeding.

    The manufacturer notes that this medication is not indicated during breastfeeding.

    Side Effects

    Breast mass
    Cervical changes
    Cervical polyp
    Endometrial polyps
    Vaginal discharge
    Weight changes


    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: April 2019

    Reference Sources

    Summary of Product Characteristics: Intrarosa 6.5mg pessary. Theramex UK Limited. Revised September 2018.

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

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    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.