Vagifem

Vag atrophy due to oestrogen deficiency in postmenopausal women. May be used in women w/ or w/o an intact uterus.

Intravaginal Initial dose: 1 vag tab daily for 2 wk. Maintenance dose: 1 vag tab twice wkly.

Hypersensitivity. Known, past or suspected breast cancer. Known, past or suspected 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, protein S, or antithrombin deficiency). Active or recent arterial thromboembolic disease (eg, angina, MI). Acute liver disease, or history of liver disease as long as LFTs have failed to return to normal. Porphyria.

Treat vag infections before starting therapy. HRT should only be initiated for postmenopausal symptoms that adversely affect quality of life. Carefully appraise risks & benefits at least annually. Limited evidence regarding risks associated w/ HRT in the treatment of premature menopause. Obtain a complete personal & family medical history before initiating or reinstituting hormone therapy. Periodic check-ups during treatment are recommended of a frequency & nature adapted to the individual woman. Closely supervise patient if any of the following conditions are present, have occurred previously, &/or have been aggravated during pregnancy or previous hormone treatment: leiomyoma or endometriosis; risk factors for thromboembolic disorders; risk factors for oestrogen-dependent tumours (eg, 1st degree heredity for breast cancer); HTN; liver disorders (eg, liver adenoma); DM w/ or w/o vascular involvement; cholelithiasis; migraine or (severe) headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Immediately w/draw therapy in case of jaundice or deterioration in liver function; significant increase in BP; new onset of migraine-type headache; pregnancy. Risk of endometrial hyperplasia & carcinoma; breast cancer; ovarian cancer; VTE; ischaemic stroke. Not recommended to add a progestagen for oestrogen products for vag application of which the systemic exposure to oestrogen remains w/in the normal postmenopausal range eg, Vagifem. Temporarily stop HRT 4-6 wk earlier if prolonged immobilisation is to follow elective surgery, & do not restart treatment until the woman is completely mobilised. Carefully consider benefit-risk of HRT use in women already on chronic anticoagulant treatment. May cause fluid retention, therefore carefully observe patients w/ cardiac or renal dysfunction. Closely monitor women w/ pre-existing hypertriglyceridaemia during HRT. May induce or exacerbate symptoms of hereditary & acquired angioedema. Increased thyroid-binding globulin, other binding proteins (corticoid-binding globulin, sex-hormone-binding globulin), & other plasma proteins (angiotensinogen/renin substrate, α-1-antitrypsin, ceruloplasmin). HRT does not improve cognitive function. Intravaginal applicator may cause minor local trauma, especially in women w/ serious vag atrophy. Not indicated during pregnancy & lactation. Limited experience in women >65 yr.

Headache; abdominal pain; vag haemorrhage, discharge or discomfort.

Consider interactions w/ other locally applied vag treatments.

Oestrogens, Progesterones & Related Synthetic Drugs

G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.

P₁S₁S₃