EstroGel
Generic name: estradiol topical (for use on skin)
Drug class: Estrogens
Medically reviewed by A Ras MD.
What is EstroGel?
Estramustine is used to treat prostate cancer. Estramustine may be given to you for other reasons. EstroGel is used after menopause to: Reduce moderate to severe hot flashes
Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place.
The sudden drop in estrogen levels causes “surgical menopause.”When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need to use estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel.
TI is also used to treat moderate to severe menopausal changes in and around the vagina
You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel to control these problems. If you use EstroGel only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
Description
EstroGel (estradiol gel) contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of EstroGel delivers 1.25 g of gel containing 0.75 mg estradiol.
Estradiol is a white crystalline powder, chemically described as estra‑1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:
The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol, triethanolamine and carbomer 934P) are pharmacologically inactive.\
Mechanism of Action
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level.
The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate‑conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.
Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
What is the most important information I should know about EstroGel?
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using EstroGel. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).
- Using estrogen-alone may increase your chances of getting strokes and blood clots.
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
- Do not use estrogens with progestins to prevent heart disease, heart attack, strokes or dementia.
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
- You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel.
Who should not use EstroGel?
Do not start using EstroGel if you:
- have unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. - currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancer, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use EstroGel. - had a stroke or heart attack
- currently have or have had blood clots
- currently have or have had liver problems
- have been diagnosed with a bleeding disorder
- are allergic to EstroGel or any of its ingredients
See the list of ingredients in EstroGel at the end of this leaflet. - think you may be pregnant
EstroGel is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use EstroGel if the test is positive and talk to your healthcare provider.
What should I tell my healthcare provider before using EstroGel?
Before you use EstroGel, tell your healthcare provider if you:
- have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. - have any other medical conditions
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or high calcium levels in your blood. - are going to have surgery or will be on bed rest
Your healthcare provider will let you know if you need to stop using EstroGel. - are breastfeeding
The hormone in EstroGel can pass into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how EstroGel works. EstroGel may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use EstroGel?
For detailed instructions, see the step-by-step instructions that come with EstroGel.
- Use EstroGel exactly as your healthcare provider tells you to use it.
- EstroGel is for skin use only.
- EstroGel contains alcohol, which is flammable. Avoid fire, flame or smoking until EstroGel has dried.
- You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with EstroGel.
What are the possible side effects of EstroGel?
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
- Heart attack
- Stroke
- Blood clots
- Dementia
- Breast cancer
- Cancer of the lining of the uterus (womb)
- Cancer of the ovary
- High blood pressure
- High blood glucose
- Gallbladder disease
- Liver problems
- Changes in your thyroid hormone levels
- Enlargement of benign tumors (“fibroids”)
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- New breast lumps
- Unusual vaginal bleeding
- Changes in vision or speech
- Sudden new severe headaches
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
Less serious, but common side effects include:
- Headache
- Breast pain
- Stomach or abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
These are not all of the possible side effects of EstroGel. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away. You may report side effects to ASCEND Therapeutics US, LLC at 1‑877-204-1013 or to FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with EstroGel?
- Talk with your healthcare provider regularly about whether you should continue using EstroGel.
- If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.
- The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).
- See your healthcare provider right away if you get vaginal bleeding while using EstroGel.
- Have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else.
- If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast x-ray), you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances of getting heart disease.
Ask your healthcare provider for ways to lower your chances of getting heart disease.
General information about the safe and effective use of EstroGel
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use EstroGel for conditions for which it was not prescribed. Do not give EstroGel to other people, even if they have the same symptoms you have. It may harm them.
This patient leaflet summarizes the most important information about EstroGel. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about EstroGel that is written for health professionals.
For more information, go to WWW.ESTROGEL.COM, or call ASCEND Therapeutics US, LLC at 1-877-204-1013.
How should I store EstroGel?
- Store EstroGel at room temperature between 68°F to 77°F (20°C to 25°C).
Keep EstroGel and all medicines out of the reach of children.
What are the ingredients in EstroGel?
Active ingredient: estradiol
Inactive ingredients: purified water, alcohol, triethanolamine, and carbomer 934P.
Label
PRINCIPAL DISPLAY PANEL – ESTROGEL 50G CARTON
- NDC 17139-617-40
ESTROGel ® 0.06%
(estradiol gel)
For Topical Use Only.
A multiple-dose pump
containing 50 grams (1.75 oz)
Rx only
