What is a Generic Drug?
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.
Elestrin (Estradiol)
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Product Details
Description
Elestrin (estradiol gel) is an estrogen used to treat moderate to severe hot flashes in menopausal women.
Fact Table
Formula
C18H24O2
License
EU EMA
Bioavailability
more than 5%
Legal status
Rx-Only
Chemical Name
Estradiol
Elimination half-life
13–20 hours
Dosage (Strength)
0.06% 52g Gel
Pregnancy
Consult Doctor
Brands
Elestrin
Protein binding
98%
PubChem CID
5757
MedlinePlus
a605041
ChEBI
16469
ATC code
G03CA03
DrugBank
DB00783
KEGG
D00105
Routes of administration
topical
Directions
Elestrin is available in a metered dose pump. One pump actuation delivers 0.87 grams of gel providing 0.52 mg of estradiol.
The typical starting dose is to apply 0.87 grams (one pump actuation) to skin that is clean, dry, and unbroken on the upper arm once daily. Your doctor may adjust your dose if needed.
Wash your hands with soap and water after applying Elestrin gel. Let the gel dry for at least 5 minutes before dressing. Do not apply the gel to the breast or in or around the vagina. Do not let anyone touch the skin where you applied the gel for at least 2 hours after application.
Ingredients
The active ingredient in Elestrin is Estradiol.
Contraindications
Do not use Elestrin (estradiol gel) if you have:
- Undiagnosed abnormal genital bleeding
- Had or currently have breast cancer
- Estrogen-dependent neoplasia
- Had or currently have an active deep vein thrombosis or pulmonary embolism
- Had known anaphylactic reaction, swelling, or hypersensitive reaction with Elestrin
- Liver impairment or disease
- Protein C, protein S, antithrombin deficiency, or other thrombophilic disorders
Cautions
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER
See full prescribing information for complete boxed warning.
Estrogen-Alone Therapy
- There is an increased risk of endometrial cancer in a woman with a
uterus who uses unopposed estrogens - Do not use estrogen-alone therapy should 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- Do not use estrogen plus progestin therapy 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 study 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
- Talk to your doctor about your medical history, medical conditions, allergies, and medications.
- Elestrin may increase your risk for gallbladder disease.
- Elestrin may increase calcium levels in the blood.
- Tell your doctor if you have visual problems. Elestrin can cause a condition known as retinal vascular thrombosis.
- Tell your doctor if you have cholesterol problems.
- Tell your doctor if you have liver problems.
- Tell your doctor if you have thyroid problems.
- Tell your doctor if there is any chance that you are pregnant or plan to become pregnant.
- Tell your doctor if you are breastfeeding or plan to breastfeed.
Side Effects
Elestrin (estradiol gel) can cause side effects. The most common include breast tenderness, spotting or vaginal bleeding, common cold, and upper respiratory tract infection.
Seek medical care right away if you experience any of the following:
- Symptoms of a heart attack: chest pain, cold sweats, pain in the left arm, trouble breathing
- Symptoms of a stroke: Onset of weakness on one side of your body, headaches, difficulty breathing, slurred speech, blurry vision
- Symptoms of blood clots: pain, redness, or swelling in the legs, legs that are warm, breathing trouble, chest pain, cough
- Breast lumps
- Abnormal vaginal bleeding
References:
- Elestrin Prescribing Information. Somerset, NJ: Meda Pharmaceuticals Inc.; 2020.
- Estradiol gel. GoodRx. Accessed January 30, 2022.
Frequently Asked Questions about Elestrin (Estradiol Gel)
What is Elestrin?
Elestrin is a brand name for estradiol gel, a topical medication used to treat moderate to severe hot flashes and night sweats associated with menopause.
How does it work?
Elestrin delivers estradiol, a female sex hormone, through your skin, replacing the declining levels after menopause. This helps manage menopausal symptoms.
Who should use Elestrin?
Women experiencing moderate to severe hot flashes and night sweats due to menopause may benefit from Elestrin. However, it's crucial to consult your doctor to ensure it's suitable for you.
How is it applied?
Elestrin comes in a metered-dose pump. You apply a thin layer of gel once daily to the upper arm or shoulder area. Wash your hands thoroughly after application.
What dosage is typically used?
The starting dose is usually one pump (0.52 mg estradiol) daily. Your doctor may adjust the dosage based on your response and symptom severity.
How long does it take to work?
Some women experience improvement in hot flashes within a week, while others may take several weeks. Be patient and discuss your progress with your doctor.
What are the common side effects?
Side effects may include headache, nausea, breast tenderness, skin reactions, and mood changes. Inform your doctor if any side effects become bothersome or worsen.
Are there any serious risks associated with Elestrin?
Elestrin may increase the risk of blood clots, stroke, heart attack, breast cancer, and endometrial cancer. Talk to your doctor about your individual risk factors before starting treatment.
Can I use Elestrin if I have other health conditions?
Certain medical conditions like uncontrolled high blood pressure, liver disease, or a history of certain cancers may make Elestrin unsuitable. Discuss your complete medical history with your doctor.
Are there any interactions with other medications?
Elestrin can interact with other medications, potentially affecting their effectiveness or increasing side effects. Inform your doctor about all medications and supplements you take.
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.Product Code : 13577
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