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Oestrogel: new packaging (yet again)?

1000 replies

Cosmetichamster · 12/12/2022 12:07

Hi ladies,

Just got this month's prescription for Oestrogel, and I have been issued with a bottle that is new (to me at least). Have a look at the photo: left is what I have known and used since June this year, on the right is the new bottle, also from Besins, same labels, same ingredients, and long use by date (07/25). Obtained from a reputable pharmacy, which has filled all my previous HRT prescriptions.

Has anyone seen this sort of thing? Slightly freaked out here. Shock

Oestrogel: new packaging (yet again)?
OP posts:
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121
everythingyouneedtoknow · 04/11/2023 15:52

@Azaleah can you say more about the time it takes for estrogen to reach a steady state in the body and tissues etc? I hear this said in various forums online but all I can find in research is info about how long it takes after applying one dose for serum estrogen to rise and peak, nothing about long term…

My bloods on 4 pumps of cylindrical were 283pmol and I still have bad night time symptoms: Heart beats hard and faster than usual at night when I’m trying to fall asleep; inner tremors at night (feels like a buzzing in my feet but if it gets bad can become core/whole body); hypnic jerks (startling awake just as I fall asleep)… and unsurprisingly insomnia.

So I’ve just gone up to 5 pumps now and might need 6 but just not sure how long to give it. My dr (Newson) said 4-6wks. Do you know any research about how long it takes for levels to settle in tissues etc?

Azaleah · 04/11/2023 16:35

@everythingyouneedtoknow Unfortunately, all I have is the information from the PIL (below). It appears that only the basic studies needed to approve Oestrogel are available, but I'll take a look at Google Scholar for more recent data. As these levels depend on the individual's unique absorption and metabolic rates, the differences are likely very variable, hence the lack of studies.

5.2 Pharmacokinetic properties

Absorption

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.

Distribution

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 24hour dose interval after administration of 2.5 g of Oestrogel on Day 12 were 76.8 pg/ml and 95.7 pg/ml, respectively.

BlessedMog · 04/11/2023 16:57

Hi,
Hope everyone is having a good afternoon.

Really pleased I found this thread which is helping me make sense of returning symptoms following a change to a new bottle design of Oestrogel. Not pleased that it seems to be a common theme though.
It took me a while to put 2+2 together but symptoms are fully back after the switch to the cylindrical bottle. I was doing pretty well on the old blue lidded bottle but have felt rubbish for the past month or so and I can’t help but think it must be connected to the switch to the new bottle. Itching, low mood, mood swings, tearful all the usual.

I spoke to the pharmacist yesterday and asked whether they had the ‘old’ blue lid design in stock. They didn’t, they had Oestrodose and the cylinder bottle with the white lid.

The pharmacist suggested I try other pharmacies out of the area who may have old stock but given that they can’t open the boxes how will they/I know if it’s the blue lid version? Is there a code they/I could look for?

I assume the old design is in a bigger box but my head is so frazzled I can’t remember if this is the case and I don’t have anything to compare it to I.e. an old bottle. Apologies if this is a daft question. I just want the old gel back. Thank you.

Azaleah · 04/11/2023 17:07

@everythingyouneedtoknow This is a very old quote from a panel on HRT regimens, but it's interesting. Note that Oestrogel was marketed by a different pharmaceutical company.

A RETROSPECTIVE ASSESSMENT OF SIXTEEN YEARS
EXPERIENCE WITH OESTROGEL® IN THREE SPECIALIST
MENOPAUSE CLINICS

NJ Colville, KE Morris, D Ross, VA Godfiee, AJ Cooper, CP
Soencer. MI Whitehead.
King’s College Hospital, London, SE5 9RS, Amarant Centre,
London, SE1 7PW, Queen Charlotte’s & Chelsea Hospital, London,
W6 OXG. UK.

Oestrogel® (Hoechst Marion Roussel, Denham, UK) is a 17beta-
oestradiol gel for cutaneous application. Widely used by
postmenopausal women in France, it has only recently been licensed
in the UK, but was previously used on a named-patient basis by
specialist centres. We report the results of a case records review of
these patients.
Analysis has so far been performed on 75 cases. The cohort has a
mean ± SD age of 57.4 f 8.8 years and a mean ± SD age at LMP or
onset of climacteric symptoms of 45.4 ± 7.1 years. Forty-three
(57%) had had a premenopausal hysterectomy (H), of whom 15
(20% of total) had also had a premenopausal BSO (H+BSO). Age at
menopause was lowest in the H+BSO group (41.7 ± 8.8); age at
onset of climacteric symptoms was significantly lower in
hysterectomised, non-oophorectomised women than in women with
an intact uterus (44.3 ± 6.9 vs. 48.2 ± 5.3, p=O.O2), confirming
previous reports of the effect of hysterectomy.

Oestrogel® was the first HRT used by 24 women (34%). Among
those who had switched from other therapies, 41 (80%) had
previously used oral preparations, 36 (71%) transdermal patches and
13 (25%) implants. Reasons given for stopping these therapies
included poor symptom relief in 35 (69%), skin irritation or poor
patch adhesion in 19 (37%), other side effects in 15 (29%) and
implant tachyphylaxis in 10 (20%). At their last visit 59 women
(79%) were still using Oestrogel® the mean duration of use was 7.1
± 5.4 years. Women who stopped Oestrogel® had used it for a mean
of 5.9 ± 5.3 years. Reasons for stopping Oestrogel® were: poor
symptom relief (3) messy to use (3) side effects (3), switched to a
no-bleed treatment (3) and other (4). Mean ± SD plasma oestradiol
in women using 5 g/d Oestrogel® (3 mg/d 17beta-oestradiol) was 349 ±
204 pmol/l.

Azaleah · 04/11/2023 17:20

BlessedMog · 04/11/2023 16:57

Hi,
Hope everyone is having a good afternoon.

Really pleased I found this thread which is helping me make sense of returning symptoms following a change to a new bottle design of Oestrogel. Not pleased that it seems to be a common theme though.
It took me a while to put 2+2 together but symptoms are fully back after the switch to the cylindrical bottle. I was doing pretty well on the old blue lidded bottle but have felt rubbish for the past month or so and I can’t help but think it must be connected to the switch to the new bottle. Itching, low mood, mood swings, tearful all the usual.

I spoke to the pharmacist yesterday and asked whether they had the ‘old’ blue lid design in stock. They didn’t, they had Oestrodose and the cylinder bottle with the white lid.

The pharmacist suggested I try other pharmacies out of the area who may have old stock but given that they can’t open the boxes how will they/I know if it’s the blue lid version? Is there a code they/I could look for?

I assume the old design is in a bigger box but my head is so frazzled I can’t remember if this is the case and I don’t have anything to compare it to I.e. an old bottle. Apologies if this is a daft question. I just want the old gel back. Thank you.

Cylindrical bottles have a smaller box, ask for the bigger ones or even Oestrodose, which seems to be more consistent than Oestrogel in cylindrical bottles.

Oestrogel: new packaging (yet again)?
Azaleah · 04/11/2023 17:35

@everythingyouneedtoknow This is a very recent review article on oestrogen-based therapies for menopausal symptoms and it does mention Oestrogel. I have required patience access to the full article.

Best Practice & Research Clinical Endocrinology & Metabolism
Available online 12 June 2023, 101789
In Press, Corrected Proof

Oestrogen-based therapies for menopausal symptom

https://doi.org/10.1016/j.beem.2023.101789

Redirecting

https://doi.org/10.1016/j.beem.2023.101789

BlessedMog · 04/11/2023 17:40

Brilliant. Thank you. I’ll be on the hunt, armed with the photo of the boxes.
The local pharmacy did have Oestrodose available but I wasn’t sure on what it was.
I may go back and try that if all else fails.
Are we expecting the blue bottle to make a come back or is it all pot luck? 😩

Azaleah · 04/11/2023 17:43

@BlessedMog I can reply to this question with 100% certainty! POT LUCK. Good luck and keep us posted.

everythingyouneedtoknow · 04/11/2023 17:45

My understanding is that the blue lidded bottles are being phased out. Besins built new factories or something to meet demand and the new factories are all making cylindrical bottles.... apparently.

@Azaleah thanks, when it says "Mean ± SD plasma oestradiol
in women using 5 g/d Oestrogel® (3 mg/d 17beta-oestradiol) was 349 ±
204 pmol/l." .... how many pumps of gel is 3mg of beta-oestradiol....?

Azaleah · 04/11/2023 17:50

everythingyouneedtoknow · 04/11/2023 17:45

My understanding is that the blue lidded bottles are being phased out. Besins built new factories or something to meet demand and the new factories are all making cylindrical bottles.... apparently.

@Azaleah thanks, when it says "Mean ± SD plasma oestradiol
in women using 5 g/d Oestrogel® (3 mg/d 17beta-oestradiol) was 349 ±
204 pmol/l." .... how many pumps of gel is 3mg of beta-oestradiol....?

Each pump of 1.25 g of gel has 0.75 mg of estradiol, so '5 g/d Oestrogel® (3 mg/d 17beta-oestradiol)' = 4 pumps.

The bottle/pouch/pump combo is supplied to Besins by two French suppliers, Lablabo (cylindrical bottles) and Nemera (conical bottles).

everythingyouneedtoknow · 04/11/2023 17:52

@Azaleah thanks, sorry maths is not my strong point (arts background here!).... what does 349 ± 204 pmol/l mean...?

Azaleah · 04/11/2023 17:56

everythingyouneedtoknow · 04/11/2023 17:52

@Azaleah thanks, sorry maths is not my strong point (arts background here!).... what does 349 ± 204 pmol/l mean...?

This means that the results obtained varied from 349 + 204 = 553 pmol/l to 349 - 204 = 145 pmol/l, that is, the variation is huge between different women.

Arts? How exciting! 😁

everythingyouneedtoknow · 04/11/2023 18:21

Wow that is vv interesting. So basically, there is massive variation and there is no correlation between anything and we just need to individually find what works LOL!!! I like the tip about moisturised skin absorbing better. I will try moisturising my thighs before bed(!) so hopefully they will absorb my gel better in the morning....

Azaleah · 04/11/2023 18:33

everythingyouneedtoknow · 04/11/2023 18:21

Wow that is vv interesting. So basically, there is massive variation and there is no correlation between anything and we just need to individually find what works LOL!!! I like the tip about moisturised skin absorbing better. I will try moisturising my thighs before bed(!) so hopefully they will absorb my gel better in the morning....

Ooops, where's the tip about moisturised skin?

everythingyouneedtoknow · 04/11/2023 18:34

"It is important to remember that many factors affect absorption of transdermal medications, and this has been studied greatly. More hydrated skin better absorbs medication (Singh and Morris 2011)...."

Azaleah · 04/11/2023 19:06

everythingyouneedtoknow · 04/11/2023 18:34

"It is important to remember that many factors affect absorption of transdermal medications, and this has been studied greatly. More hydrated skin better absorbs medication (Singh and Morris 2011)...."

Okay, thanks. I used to take a shower and wait an hour before applying the gel, so I was thinking abourt this sort of hydration! I think that in my case if I apply the moisturiser before bed and the gel in the morning, it's possible that the moisturiser will negatively affect absorption because I always feel like there's a layer of moisturiser left on my skin when I shower!

everythingyouneedtoknow · 04/11/2023 19:08

I'm going to try moisturising before bed and then washing it off really well in the morning...

Azaleah · 04/11/2023 19:08

everythingyouneedtoknow · 04/11/2023 19:08

I'm going to try moisturising before bed and then washing it off really well in the morning...

Perfect!

Amscott36 · 05/11/2023 14:53

Hi all,

Thank God for mumsnet! I have noticed that my symptoms are returning with memory fog. Noticed this I saw the new design bottle and both my friend and I noticed that the new pump pumps out a lot less than the old design bottle. We have both decided to do 2.5 pumps a day if not three..and that seems to work.

mrsnjw · 05/11/2023 14:56

I have bought some cheap jewellery scales from Amazon and I weigh my gel out now every morning. I always have to add a bit more to the two pumps.

everythingyouneedtoknow · 05/11/2023 17:56

@mrsnjw how much should each pump weigh and how do you know that? and when you add more, visually how much more is it? an extra quarter of a pump? half...?

mrsnjw · 05/11/2023 17:59

Isn't each pump supposed to be 1.25mg? So I measure out 2.5mg. It usually comes out at 1.16mg per pump so I add a bit more. Its not a huge amount but if you're really sensitive to the amount of gel you need it would make a difference.

Azaleah · 05/11/2023 19:28

mrsnjw · 05/11/2023 17:59

Isn't each pump supposed to be 1.25mg? So I measure out 2.5mg. It usually comes out at 1.16mg per pump so I add a bit more. Its not a huge amount but if you're really sensitive to the amount of gel you need it would make a difference.

1.25 grams, not milligrams. Yes, sensitive women might feel a difference and that's not ideal, but until this mess is sorted out I supposen it's better than swapping to other type of HRT.

Amscott36 · 05/11/2023 21:19

Hi @mrsnjw

Could you put the link of where you got the jewellery scales please?

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