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Estrogel (Estradiol Gel)

Known as Oestrogel in the UK

Prescription medicineOnly Available By Prescription
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Strength Pack Size Qty
Strength
0.06% Gel
Pack Size
Qty

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Description

EstroGel 0.06% (estradiol gel) is a topical estrogen gel used to treat symptoms of menopause and vuvlar and vaginal atrophy associated with menopause.

Directions

Carefully read the information and follow the instructions that come with your EstroGel prescription. Refer any questions or concerns to your doctor or pharmacist.

EstroGel is available in a 50 gram metered-dose pump. Before using EstroGel for the first time, you need to prime the pump by pressing the pump 5 times. Throw the unused gel in the trash or rinse it down the sink. 

One pump depression of EstroGel should be applied to the arm once daily. Apply a thin layer of the gel on the inside and outside of the entire arm, from the wrist to the shoulder. One pump depression delivers 1.25 grams of gel that contains 0.75 mg of estradiol. Wash your hands with soap and water after each use.

Keep away from children. Store at 20°C to 25°C (68° to 77°F). 

Ingredients

EstroGel contains estradiol. The base is made of a hydroalcoholic gel that's absorbed. Other components of the gel include purified water, alcohol, triethanolamine, and carbomer 934P. 

Contraindications

Avoid using Estrogel if you:

  • Have unusual, undiagnosed vaginal bleeding 
  • Have, think you have, or have had breast cancer
  • Have or think you have estrogen-dependent neoplasia
  • Currently have an active blood clot in the legs or lungs or have had a blood clot in the legs or lungs 
  • Currently have an active stroke or heart attack or have had a stroke or heart attack
  • Have had an allergic reaction or angioedema (swelling underneath the skin) to EstroGel
  • Have liver disorders
  • Have protein C, protein S, antithrombin deficiency, or other disorders that cause easy blood clotting
  • Are pregnant or think that you are pregnant

Cautions

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

See full prescribing information for complete boxed warning

Estrogen-Alone Therapy

  • ? There is an increased risk of endometrial cancer in women with a
    uterus who use unopposed estrogens 
  • ? Estrogen-alone therapy should not be used for the prevention of
    cardiovascular disease or dementia 
  • ? The Women's Health Initiative (WHI) estrogen-alone substudy
    reported increased risks of stroke and deep vein thrombosis (DVT)
  • ? The WHI Memory Study (WHIMS) estrogen-alone ancillary study of
    WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older 

Estrogen Plus Progestin Therapy

  • ? Estrogen plus progestin therapy should not be used for the prevention
    of cardiovascular disease or dementia 
  • ? The WHI estrogen plus progestin substudy reported increased risks of
    stroke, DVT, pulmonary embolism (PE), and myocardial infarction
    (MI) 
  • ? The WHI estrogen plus progestin substudy reported increased risks of
    invasive breast cancer 
  • ? The WHIMS estrogen plus progestin ancillary study of WHI reported
    an increased risk of probable dementia in postmenopausal women 65 years of age and older

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. 

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. 

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo. 

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. 

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. 

The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary emboli (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. 

The WHIMS estrogen plus progestin ancillary study of the WHI reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) plus MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. 

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. 

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

  • Before you start using Estrogel, discuss the following with your doctor:
    • All the medications you take
    • Your allergies
    • Your medical history and health problems
    • Your pregnancy or breastfeeding status 
  • Gallbladder disease that warrants surgery can occur in postmenopasual women who receive estrogens.
  • High calcium levels can occur in patients with breast cancer and bone cancer and are receiving estrogens.
  • Estrogens may cause vision problems.
  • Endometrial hyperplasia, which can lead to endometrial cancer, can occur with the use of estrogens.
  • The risk of breast cancer is increased with the use of progestins with estrogens.
  • High blood pressure can occur with estrogen use.
  • High triglyceride levels that can lead to pancreatitis in women who have pre-existing high triglyceride levels can occur with estrogen use.
  • Patients with liver problems should use estrogens with caution.
  • Patients who are receiving estrogens and thyroid replacement therapy may require a dose increase in their thyroid replacement therapy.
  • Estrogen therapy may cause fluid retention.
  • Patients who have hypoparathyroidism and are receiving estrogen therapy may experience low calcium levels.
  • Women who've had a hysterectomy and are receiving estrogens may experience worsening endometriosis.
  • Angioedema may be worsened in women who have hereditary angioedema and are receiving estrogen therapy.
  • Asthma, diabetes, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas may worsen during treatment with estrogens.
  • Do not smoke or go around fire or flames until the EstroGel has completely dried.
  • The absorption of EstroGel is significantly increased when using lotion one hour after applying EstroGel.

Side Effects

EstroGel side effects include endometrial cancer, breast cancer, breast pain, breast tenderness, blood clots in the legs, certain heart problems, vein inflammation, nausea, abdominal distension, diarrhea, stomach discomfort, hair loss, skin conditions, vision problems, headache, dizziness, trouble sleeping, numbness, loss of the ability to communicate, slowness of thought, and tingling or prickling sensation. If you experience bothersome or continuous side effects, call your doctor right away.

Looking for a low EstroGel price? You can buy EstroGel at a competitive cost online and with a valid prescription from your doctor at Canada Drugs Direct.

Reference:

EstroGel 0.06% (estradiol gel) for topical use. Herndon, VA: ASCEND Therapeutics US, LLC; 2020.



IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

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