Estriol 30 microgram pessary
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Pessary containing estriol.
Drugs List
Therapeutic Indications
Uses
Local treatment for vaginal symptoms of oestrogen deficiency:postmenopausal
Local treatment of vaginal symptoms of oestrogen deficiency in postmenopausal women.
Dosage
Adults
Insert one pessary in the evening before bed, for three weeks.
Thereafter, insert one pessary twice a week in the evening before bed.
Continued treatment should be on the lowest effective dose for the shortest period.
Additional Dosage Information
Missed pessary insertion
During daily use within the first three weeks:
If a missed dose is not realised before the following day, it should not be replaced. Resume normal dose schedule.
During twice weekly use:
A missed dose should be administered as soon as possible.
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
Precautions and Warnings
Predisposition to thromboembolic disease
Prolonged immobilisation
Recent surgery
Severe headache
Asthma
Cardiac impairment
Cholelithiasis
Diabetes mellitus
Endometrial hyperplasia
Endometriosis
Epileptic disorder
Hepatic adenoma
Hepatic disorder
Hypertension
Hypertriglyceridaemia
Migraine
Otosclerosis
Renal impairment
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
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
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
Uterine fibroids may increase in size
Discontinue 4 - 6 weeks before major surgery
Advise patient to seek advice at first indications of pregnancy
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if cholestasis develops
Discontinue if first occurrence or worsening of migraine/severe headache
Discontinue if jaundice or other evidence of hepatic impairment occurs
Discontinue if pre-existing uterine fibroids increase in size
Discontinue if significant rise in blood pressure occurs
Discontinue if sudden pain in the chest occurs
Discontinue if symptoms due to endometriosis are exacerbated
Female: Not for contraception.Use non-hormonal contraception, if required
Male & female: Damages latex condoms and diaphragms
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.
For the treatment of menopausal symptoms the benefits of short-term HRT are considered to outweigh the risks in the majority of women.
In all cases, it is good practice to use the lowest effective dose for the shortest possible time and to review the need to continue treatment at least annually.
Physical examination should be guided by this and a knowledge of the contraindications and precautions and warnings for use of the product. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified according to the clinical needs of the individual.
There is an increased risk of breast cancer in women currently or recently using systemic Hormone Replacement Therapy (HRT). The risk of breast cancer increases with the duration of treatment and returns to normal after 5 years of stopping treatment. This risk applies to a lesser extent for vaginal application.
Treatment with vaginal estriol has not been attributed to an increased risk of endometrial hyperplasia or uterine cancer. Oestrogen products for vaginal application where the oestrogen exposure is low should not be given with progestagen. The saftey of long term or repeated use of vaginally administered oestrogen on the endometrium is uncertain. Examinations to rule out endometrial abnormalities should be undertaken at regular intervals.
Pregnancy and Lactation
Pregnancy
Estriol pessaries are contraindicated during pregnancy.
Should pregnancy occur, treatment should be discontinued immediately.
At the time of writing there is limited published information regarding the use of vaginally applied estriol during pregnancy. Potential risks are unknown. The manufacturer suggests current studies indicate no teratogenic or fetotoxic effects in the event of inadvertent exposure.
Lactation
Estriol pessaries are contraindicated during breastfeeding.
The manufacturer advises very low doses of vaginally applied estriol are unlikely to affect lactation.
Counselling
Advise patient of the increased risk of breast cancer vs benefits of HRT.
Advise patient that changes in their breasts should be reported to Dr/nurse.
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.
Advise women of child bearing potential that HRT does not provide contraceptive cover and non-hormonal contraception should be used during treatment.
Advise patient to seek advise at first indications of pregnancy
Advise patient to discontinue therapy if abnormal neurological signs develop.
Advise patient of thromboembolic symptoms and to report them if they occur (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
Side Effects
Dysuria
Irritation (localised)
Local pain
Pruritus
Rectal discomfort
Vaginal discharge
Vulvovaginal burning
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 Updated: September 2019
Reference Sources
Summary of Product Characteristics: Imvaggis 0.03mg pessary. Besins Healthcare Ltd. Revised November 2018.
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