This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Estriol 50micrograms/g vaginal gel

Presentation

Vaginal gel containing estriol.

Drugs List

  • BLISSEL 50microgram/g vaginal gel
  • estriol 50microgram/g vaginal gel
  • Therapeutic Indications

    Uses

    Atrophic vaginitis - post-menopausal

    Local treatment of vaginal dryness in postmenopausal women with vaginal atrophy.

    Dosage

    Treatment can be started any time after the manifestation of atrophic vaginitis.

    Adults

    Initial dose: One applicator dose (50 micrograms estriol) of vaginal gel per day at bedtime, for 3 weeks.
    Maintenance dose: One applicator dose (50 micrograms estriol) of vaginal gel at bedtime, twice a week.

    Evaluate treatment after 12 weeks to determine the need for continuation.

    Additional Dosage Information

    Administer a missed dose as soon as remembered unless it is 12 hours overdue. If 12 hours has elapsed, skip the missed dose and administer the following dose at the normal time.

    Administration

    For intravaginal use.

    The gel should be inserted preferably before going to bed. The applicator containing the gel should be inserted deep into the vagina and the plunger should slowly be pushed down until emptied.

    After use, the plunger should be removed from the cannula and cleaned or rejected as indicated in the manufacturers information.

    Contraindications

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

    Precautions and Warnings

    Family history of breast cancer
    Predisposition to thromboembolic disease
    Severe headache
    Asthma
    Cholelithiasis
    Diabetes mellitus
    Endometrial hyperplasia
    Endometriosis
    Epileptic disorder
    Hepatic adenoma
    Hepatic disorder
    Hypertension
    Migraine
    Otosclerosis
    Severe 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
    Contains hydroxybenzoate
    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
    Advise patient that changes in their breasts should be reported to Dr/nurse
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if first occurrence or worsening of migraine/severe headache
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Discontinue if significant rise in blood pressure occurs

    Use caution in patients who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis.

    Pregnancy and Lactation

    Pregnancy

    Estriol is contraindicated during pregnancy as not indicated.

    The manufacturer does not recommend using estriol during pregnancy. Withdraw treatment immediately if pregnancy occurs.

    Lactation

    Estriol is contraindicated during breastfeeding as not indicated.

    Side Effects

    Application site reaction
    Candidiasis
    Genital pruritus
    Genital rash
    Headache
    Heat (local)
    Irritation (localised)
    Itching sensation (local)
    Pelvic pain
    Prurigo
    Pruritus

    Overdosage

    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 ).

    Further Information

    Last Full Review Date: May 2019

    Reference Sources

    Summary of Product Characteristics: Blissel 50 micrograms/g vaginal gel. Flynn pharmaceuticals Ltd. Revised April 2017.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 May 2019

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

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

    FDB Logo

    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.