Pain in the breasts or excessive production of cervical mucus may be indicative of too high a dosage, but acute overdosage has not been reported and is unlikely to be a problem. Overdosages of oestrogen may cause nausea, and withdrawal bleeding may occur. There are no specific antidotes and treatment should be symptomatic.
3 years
Not known.
-Ethanol
-Carbomer
-Triethanolamine
-Purified water
No relevant information additional to that already contained in the SPC.
ATC Code: G03CA03.
Sex Hormones and Modulators of the Genital System - Natural and Semisynthetic Oestrogens, plain.
The active ingredient, 17β-oestradiol, is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms.
Oestrogel prevents bone loss following menopause or ovariectomy.
Clinical trial information
- Relief of oestrogen deficiency symptoms and bleeding patterns
Relief of menopausal symptoms was achieved during the first few weeks of treatment. The rate of regular withdrawal bleeding or amenorrhoea depends on the individual posology and may vary on the individual patient.
- Prevention of osteoporosis
- Oestrogen deficiency at menopause is associated with an increasing bone turnover and decline in bone mass.
- The effect of oestrogens on the bone mineral density is dose-dependent. Protection appears to be effective for as long as treatment is continued. After discontinuation of HRT, bone mass is lost at a similar rate to that in untreated women.
- Evidence from the WHI trial and meta-analysed trials shows that current use of HRT, alone or in combination with a progestogen - given to predominantly healthy women- reduces the risk of hip, vertebral, and other osteoporotic fractures. HRT may also prevent fractures in women with low bone density and/or established osteoporosis, but the evidence for this is limited.
Pharmacokinetic studies indicate that, when applied topically to a large area of skin in a volatile solvent, approximately 10% of the oestradiol is percutaneously absorbed into the vascular system, regardless of the age of the patient. Daily application of 2.5 g or 5 g Oestrogel over a surface area of 400-750 cm2 results in a gradual increase in oestrogen blood levels to steady state after approximately 3-5 days and provides circulating levels of both oestradiol and estrone equivalent in absolute concentrations and in their respective ratio to those obtained during the early-mid follicular phase of the menstrual cycle.
Oestrogel was administered to 17 postmenopausal women once daily on the posterior surface of one arm from wrist to shoulder for 14 consecutive days.
Maximum serum concentrations (Cmax) of oestradiol and estrone on Day 12 were 117 pg/ml and 128 pg/ml, respectively.
The time-averaged serum oestradiol and estrone concentrations (Caverage) over the 24 hour dose interval after administration of 2.5 g of Oestrogel on Day 12 were 76.8 pg/ml and 95.7 pg/ml, respectively.
Metabolism of oestradiol takes place mainly in the liver under oestriol, estrone and their conjugated metabolites (glucuronides, sulphates). These metabolites also undergo enterohepatic recirculation.
When treatment is stopped, oestradiol and urinary conjugated oestradiol concentrations return to baseline in about 76 hours.
22 December 2017
Besins Healthcare
Avenue Louise, 287
B-1050 Brussels
Belgium
Do not store above 25°C.
Metering canister composed of a polypropylene bottle, a LDPE pouch, a polypropylene metering pump and closed with a polypropylene cap, containing 80 g of gel.
PL 28397/0002
No special requirements
1 November 1997
