Estriol vaginal cream 0.01%
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Vaginal cream containing estriol (0.01%).
Atrophic vaginitis - post-menopausal
Kraurosis vulvae- post menopausal
Hormone replacement therapy for the treatment of atrophic vaginitis and kraurosis in post-menopausal women.
Treatment of pruritus vulvae and dyspareunia when associated with atrophic vaginal epithelium.
Treatment may begin any time after the manifestation of atrophic vaginitis or associated symptoms, such as dyspareunia or pruritus.
The lowest dose that will control symptoms should be used and treatment should be discontinued as soon as possible. The discontinuation of therapy should be considered at 3 to 6 monthly intervals following physical examination.
0.5mg estriol (one applicator full of vaginal cream) daily.
0.5mg estriol (one applicator full of vaginal cream) twice a week may be used when the vaginal mucosa has been restored.
For intravaginal use.
The applicator of cream should be inserted high into the vagina, preferably in the evening.
Abnormal liver function test
Acute hepatic disorder
Deep vein thrombosis
History of breast cancer
History of hormone dependent neoplasm
History of thromboembolic disorder
Hormone dependent neoplasm
Recent arterial thromboembolic disorder
Uncontrolled endometrial hyperplasia
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Family history of breast cancer
Patients over 65 years
Predisposition to thromboembolic disease
Fibrocystic breast disorder
History of endometrial hyperplasia
History of endometriosis
Sickle cell disease
Systemic lupus erythematosus
Assess family medical history prior to commencing treatment
Exclude breast cancer before treatment
Exclude oestrogen dependent neoplasm before treatment
Contains arachis (peanut oil), soya or soya derivative
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
Discontinue treatment if patient develops seizures
Monitor hepatic function in patients with history of hepatic disease
Advise patient that changes in their breasts should be reported to Dr/nurse
Advise patient to contact a doctor if symptoms of thromboembolism develop
Discontinue at the onset of severe depression
Uterine fibroids may increase in size
May affect results of some laboratory tests
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 abnormal neurological signs develop
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 significant rise in blood pressure occurs
Discontinue if sudden pain in the chest occurs
Discontinue if symptoms due to endometriosis are exacerbated
Discontinue in the event of a prolonged period of immobilisation
Advise patient not to take St John's wort concurrently
Female: Not for contraception.Use non-hormonal contraception, if required
Male & female: Damages latex condoms and diaphragms
Advise patient of increased risk of breast cancer vs benefits of HRT
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.
There is an increased risk of breast cancer in women currently or recently using 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.
The presence of a personal or strong family history of recurrent thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition. HRT treatment should be stopped until a definitive diagnosis has been made or anticoagulant treatment initiated. Use of systemic HRT is associated with an increase risk of developing venous thromboembolism (VTE), the risk is more likely within the first year of HRT.
In all postoperative patients, prophylactic measures need to be considered to prevent VTE following surgery. When prolonged immobilisation is to follow elective surgery temporarily stopping HRT 4 to 6 weeks earlier is recommended. Treatment can be resumed when the patient is completely mobilised.
Estriol vaginal cream contain arachis (peanut) oil and should be avoided by patients with peanut allergy. There is a possible relationship between peanut and soya allergy therefore patients allergic to soya should also avoid this formulation.
Pregnancy and Lactation
Estriol vaginal cream is contraindicated during pregnancy.
The manufacturer does not recommend using estriol vaginal cream during pregnancy. Studies indicate no increased risk of teratogenic or foetotoxic effects.
Estriol vaginal cream is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst using estriol vaginal cream.
Aggravation of porphyria
Deep vein thrombosis (DVT)
Increase in plasma triglyceride concentration
Increased frequency of micturition
Increased risk of breast cancer
Increased risk of endometrial cancer
Increased risk of ovarian cancer
Increased size of uterine fibroids
Liver function disturbances
Effects on Laboratory Tests
Hormone replacement therapy, especially oestrogen-progestogen combined treatment may increase the density of mammographic images and adversely effect the detection of breast cancer.
The use of oestrogen may influence the laboratory results of certain endocrine tests and liver enzymes.
Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone. Oestrogens may also be increase corticoid binding globulin (CBG) and sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. Free or biological active hormone concentrations are unchanged.
Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrysin, ceruloplasmin). With vaginal administration, stimulation of the liver by the first-pass effect us avoided and thus, transvaginal oestrogens might affect hormone binding proteins and other serum proteins produced by the liver less than oral hormones.
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: March 2020
Summary of Product Characteristics: Estriol 0.01 % w/w cream. Marlborough Pharmaceuticals Ltd. Revised October 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 February 2020
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