Estriol 50micrograms/g vaginal gel
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Vaginal gel containing estriol.
Atrophic vaginitis - post-menopausal
Local treatment of vaginal dryness in postmenopausal women with vaginal atrophy.
Treatment can be started any time after the manifestation of atrophic vaginitis.
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.
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.
Abnormal liver function test
Acute hepatic disorder
Deep vein thrombosis
History of breast cancer
History of thromboembolic disorder
Hormone dependent neoplasm
Uncontrolled endometrial hyperplasia
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Family history of breast cancer
Predisposition to thromboembolic disease
Severe renal impairment
Systemic lupus erythematosus
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
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
Estriol is contraindicated during pregnancy as not indicated.
The manufacturer does not recommend using estriol during pregnancy. Withdraw treatment immediately if pregnancy occurs.
Estriol is contraindicated during breastfeeding as not indicated.
Application site reaction
Itching sensation (local)
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: May 2019
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
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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