Estradot 25mcg

Estradot 25 general information

What is Estradot used for?

Estradot 25 is a transdermal delivery system (skin patch) containing oestrogen that is used as a short-term hormone replacement therapy (HRT) to substitute for a lack of oestrogen production by the ovaries that happens during menopause or following surgical removal of the ovaries. Using Estradot 25 patches helps relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy. Estradot 25 is also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Estradot 25 stimulates the development of female sexual characteristics, and is used as part of a transgender hormone therapy for male to female transsexuals.

How does Estradot work?

Estradot 25 is a skin patch containing the active ingredient oestradiol, the major and the most active form of the female hormone oestrogen. When you apply the patch to your skin, the oestradiol diffuses out of the patch through your skin and into your blood, delivering a dose of 25mcg oestradiol per day. Oestrogen is a steroid hormone produced by the ovaries that binds to specific receptors inside oestrogen-responsive cells and stimulates them to make proteins involved in producing secondary sexual characteristics, such as breast development and in regulating the menstrual cycle. Oestrogen also has several other actions in various metabolic processes including maintaining bone mass and lipid (fat) metabolism. Because the oestadiol in Estradot 25 enters your blood directly and continuously, it is not metabolised (broken down) by the liver, as happens when you take oral oestrogen tablets, which means that Estradot 25 patches are effective at a lower dose and provide more even blood levels similar to the natural release of oestrogen by the ovaries.

What Estradot doses are available?

Estradot patches are available in 5 strengths, each in packs of 8 or 24 patches:

• Estradot 25 contains 0.39 mg of oestradiol in each patch and releases 25 mcg oestradiol into your blood per 24hours
• Estradot 37.5 contains 0.585 mg of oestradiol in each patch and releases 37.5 mcg oestradiol into your blood per 24hours
• Estradot 50 contains 0.78 mg of oestradiol in each patch and releases 50 mcg oestradiol into your blood per 24hours
• Estradot 75 contains 1.17 mg of oestradiol in each patch and releases 75 mcg oestradiol into your blood per 24hours
• Estradot 100 contains 1.56 mg of oestradiol in each patch and releases 100mcg oestradiol into your blood per 24hours

What does Estradot contain?

The active ingredient in Estradot 25 is oestradiol (0.39 mg of oestradiol in each patch delivered at 25mcg per day), which is the most active form of the female hormone oestrogen and is responsible for the development of female sexual characteristics and regulation of the menstrual cycle. Estradot 25 transdermal delivery system (skin patch) consists of a rectangular patch with rounded corners, comprising a pressure-sensitive adhesive layer containing estradiol, with a translucent polymeric backing on one side and a protective liner on the other. The adhesive matrix contains acrylic adhesive, silicone adhesive, oleyl alcohol, dipropylene glycol, povidone. The backing layer contains ethylene/vinyl acetate copolymer, polyethylene, vinylidene/vinyl chloride copolymer, polyethylene, ethylene/vinyl acetate copolymer co-extruded film. The release liner (to be removed before application) is a fluoropolymer-coated polyester film.

Treating symptoms of menopause with Estradot

Estradot 25 substitutes for the loss of oestrogen production by the ovaries that occurs during menopause and is the cause of symptoms such as hot flushes, night sweats, sleeplessness, dry vagina, headaches, mood swings, lack of concentration loss of energy and bone loss (osteoporosis). Estradot 25 is a transdermal delivery system (skin patch) that contains oestradiol, an active form of the female hormone oestrogen that alleviates moderate to severe menopausal symptoms.

Estradot for hormone replacement therapy (HRT)

Estradot 25 is a transdermal delivery system (skin patch) containing oestrogen that is used as a short-term hormone replacement therapy (HRT) to substitute for a lack of oestrogen production by the ovaries during the menopause. Estradot 25 is used to relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy. Estradot 25 is also used to help prevent postmenopausal bone loss (osteoporosis), which is also caused by lack of oestrogen, and reduce risk of fracture.

Estradot for transgender treatment

Estradot 25 can be used as part of a gender reassignment program for male to female transsexuals, by providing a source of oestradiol, an active form of the female hormone oestrogen. Estradot 25 is a transdermal delivery system (skin patch) for oestrogen that stimulates the development of female secondary sexual characteristics, such as breast development and also induces metabolic changes such as fat distribution to redefine the general body shape.

Estradot for feminising hormone therapy

Estradot 25 patches contain oestradiol, the most feminising form of the female hormone oestrogen, which provides a very effective means of feminisation when used as part of a gender reassignment program for male to female transsexuals. Estradot 25 is a transdermal delivery system (skin patch) for oestrogen that stimulates the development of female secondary sexual characteristics, such as breast development and also induces metabolic changes such as fat distribution to redefine the general body shape, while at the same time overriding the effects of testosterone. The consistent and prolonged release of oestadiol provides an effective approach to feminising hormone therapy.

What are the side effects of Estradot?

The most frequently reported side effects when using Estradot 25 patches are: itching under the patch, reddening of the skin after the patch has been removed (but this usually disappears within a few days), breast tenderness, breast pain, abdominal pain, nausea, oedema, and headache, skin rash and itching, insomnia and depression. More severe side effects include changes in liver function at higher doses.

What are the health risks of Estradot?

Long-term HRT with Estradot 25 does have associated health risks, including an increased risk of breast cancer, endometrial cancer, stroke and deep vein thrombosis. For women with an intact uterus adding a progestogen to an oestrogen replacement regimen like Estradot 25 patches is recommended to reduce the risk of endometrial cancer. There is also an increased risk of developing probable dementia in postmenopausal women 65 years of age or older.

When should Estradot not be used?

You should not use Estradot 25 if you:

• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have deep venous thrombosis, thromboembolic disorders, cerebral vascular accident associated with oestrogen use
• abnormal genital bleeding of unknown cause
• are pregnant or planning to become pregnant
• are allergic to oestradiol or any of the ingredients in Estradot patches
• are taking other medications that may interact with Estradot, such as anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, rifabutin, nevirapine, efavirenz, some medicines to help you sleep, including barbiturates and meprobamate or preparations containing St John's Wort

How should Estradot be used?

Estradot 25 patches can be used continually (which means you will usually have a patch on all the time) or in cycles (interrupted for one week after every 3 weeks) as recommended by your doctor. You should apply new patch twice weekly (every 3 or 4 days) and there are 8 patches in the packet, enough for a 4-week cycle.

Each patch should be used only for 3-4 days and then changed and only one patch should be worn at any time.

1. Before you apply your patch, make sure your skin is clean and dry and is not oily, broken or irritated.
2. Remove the protective liner from the adhesive side of the patch and apply the patch to your skin either on your lower abdomen, hips or buttocks (areas that remain covered) but never on your breasts. Do not put the patch on your waistline where tight clothes may rub it and avoid areas where the skin is hairy or folded or the patch may not stick.
3. Press the patch firmly in place with the palm of the hand for about 10 seconds and make sure the patch sticks well, especially around the edges.
4. Leave the patch in place for 3-4 days and then remove it and replace with a new patch straight away or as advised by your doctor.
5. Apply the next patch to a different part of your body as you should not use the same area of skin twice running.
6. If your patch accidentally falls off, dry your skin and reapply it or apply a new patch for the remainder of the 3-4 days dosing period.

How long should you use Estradot?

Estradot 25 patches can be used continually or in cycles (interrupted for one week after every 3 weeks) for as long as recommended by your doctor.

Missed dose of Estradot

Estradot 25 patches are intended to last for 3-4 days. If your patch accidentally falls off, reapply it or apply a new patch for the remainder of the 3-4 day dosing period. If you lose a patch or forget to replace it for several days, irregular bleeding may occur. Replace the patch as soon as possible.

How should Estradot be stored?

Keep Estradot 25 patches in their protective pouch until you are about to use one. Store in a cool dry place below 25°C.