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Hormones 2016

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Oestrogel<br />

Cmax of estradiol and estrone on Day 12 were 117 pg/ml and 128 pg/ml,<br />

respectively.<br />

The time-averaged serum estradiol and estrone concentrations Cavg 36 over<br />

the 24 hour dose interval after administration of 2.5 g of Oestrogel on Day<br />

12 were 76.8 pg/ml and 95.7 pg/ml, respectively.<br />

Metabolism of estradiol takes place mainly in the liver under oestriol,<br />

estrone and their conjugated metabolites (glucuronides, sulphates). These<br />

metabolites also undergo enterohepatic recirculation.<br />

When treatment is stopped, estradiol and urinary conjugated estradiol<br />

concentrations return to baseline in about 76 hours (emc, 2013).<br />

Shelf Life<br />

36 months (emc, 2013).<br />

Notes<br />

Apply gel to clean, dry, intact areas of skin such as arms, shoulders, or inner<br />

thighs and allow to dry for 5 minutes before covering skin with clothing.<br />

Not to be applied on or near breasts or on vulval region (BNF, <strong>2016</strong>a).<br />

Anecdotally I’ve heard of it being applied to inner thighs and inner arms<br />

only, as it can only penetrate one layer of skin and in these regions the skin<br />

is thinnest.<br />

Conditions which need supervision<br />

If any of the following conditions are present, have occurred previously,<br />

and/or have been aggravated during pregnancy or previous hormone<br />

treatment, the patient should be closely supervised. It should be taken into<br />

account that these conditions may recur or be aggravated during treatment<br />

with Oestrogel, in particular -<br />

• Leiomyoma (uterine fibroids) or endometriosis,<br />

• Risk factors for thromboembolic disorders,<br />

• Risk factors for oestrogen dependent tumours, e.g.<br />

heredity for breast cancer,<br />

• Hypertension,<br />

• Liver disorders (e.g. liver adenoma),<br />

• Diabetes mellitus with or without vascular involvement,<br />

• Cholelithiasis,<br />

• Migraine or (severe) headache,<br />

• Systemic lupus erythematosus (SLE),<br />

36 the average plasma concentration of a drug after administration<br />

Version <strong>2016</strong>.3576– – Document LATEXed – 1st May <strong>2016</strong><br />

96<br />

[git] • Branch: 1.5 @ 26b5e6d • Release: 1.5 (<strong>2016</strong>-05-01)<br />

first degree

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