Concise Prescribing Info
Estradiol hemihydrate
Vaginal atrophy due to oestrogen deficiency in postmenopausal women.
Dosage/Direction for Use
Initially 1 tab once daily for 2 wk. Maintenance dose: 1 tab twice wkly. May start treatment on any convenient day.
Hypersensitivity. Known, past or suspected breast cancer; oestrogen-dependent malignant tumours eg, endometrial cancer. Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous or current VTE (DVT, pulmonary embolism). Known thrombophilic disorders eg, protein C or S, or antithrombin deficiency. Active or recent arterial thromboembolic disease eg, angina, MI. Acute liver disease, or history of liver disease when liver function tests have failed to return to normal. Porphyria.
Special Precautions
Discontinue use if VTE develops after initiating therapy; jaundice or deterioration in liver function, significant increase in BP & new onset of migraine-type headache occurs. Temporarily discontinue HRT for 4-6 wk earlier if prolonged immobilization is to follow elective surgery. Not recommended to add progestogen. Not to prescribed oestrogen replacement therapy for >1 yr w/o another physical, including gynaecological exam. Leiomyoma (uterine fibroids) or endometriosis; HTN; DM w/ or w/o vascular involvement; migraine or severe headache; SLE; epilepsy; asthma; otosclerosis; cardiac or renal dysfunction. Risk factors for thromboembolic disorders; oestrogen-dependent tumours, eg, 1st degree heredity for breast cancer. May cause minor local trauma in women w/ serious vag atrophy. Women w/ intact uterus w/ abnormal bleeding of unknown aetiology or who have previously been treated w/ unopposed oestrogens; pre-existing hypertriglyceridaemia; who undergone hysterectomy; on chronic anticoagulant treatment. Increased risk of VTE & HRT in patients w/ known thrombophilic; ischaemic stroke w/ systemic oestrogen-only therapy; probable dementia in women who start using continuous combined or oestrogen-only HRT after 65 yr. Increased circulating total thyroid, T4 or T3 levels; corticosteroids & sex steroids. Increased plasma proteins eg, angiotensinogen/renin substrate, α-1-antitrypsin, ceruloplasmin. Perform screening in women w/o personal history of VTE but w/ 1st degree relative w/ history of thrombosis at young age. Woman should consult a doctor if bleeding or spotting occurs during therapy. Liver disorders; cholelithiasis. Not indicated during pregnancy & lactation.
Adverse Reactions
Headache; abdominal pain; vag haemorrhage, discharge or discomfort; erythema multiforme.
Drug Interactions
Other locally applied vag treatments.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Femiest vag tab 0.01 mg
((with applicators)) 18's
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