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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.
Femring (Estradiol acetate)
Prescription Required
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Product Details
Description
Femring is a vaginal ring that contains estradiol acetate, a female hormone. Femring is indicated for the treatment of hot flashes, vaginal irritation, and vaginal dryness in women who have menopause.
Fact Table
Formula
C18H24O2
License
EU EMA
Bioavailability
Less than 5%
Legal status
Rx-Only
Chemical Name
Estradiol
Elimination half-life
13 - 36.5 hours
Dosage (Strength)
0.05mg, 0.1mg
Pregnancy
Consult Doctor
Brands
Femring
Protein binding
98%
PubChem CID
5757
MedlinePlus
a605041
ChEBI
16469
ATC code
G03CA03
DrugBank
DB00783
KEGG
D00105
Routes of administration
Ring
Directions
Femring may be inserted into your vagina by you or your doctor. Hands should be washed before and after insertion of the ring. Follow the instructions that are included with your prescription. Call your doctor if you are unsure how to insert the ring.
Femring should stay in place for 3 months. After 3 months the Femring should be replaced with a new one.
Ingredients
The female hormone, estradiol acetate, is the active ingredient in Femring.
Contraindications
Do not use Femring if you have any of the following conditions:
- Undiagnosed abnormal genital bleeding
- Have breast cancer, suspect you have breast cancer, or have a history of breast cancer
- Have or suspect estrogen-dependent neoplasia
- Have an active deep vein thrombosis, pulmonary embolism, or a history of these conditions
- Have or had a stroke or heart attack within the past year
- Liver impairment or liver disease
- Allergy to Femring or any of its ingredients
- Pregnant, think you are pregnant, or plan to become pregnant
Cautions
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA FOR ESTROGEN-ALONE THERAPY
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], relative to placebo.
The Women's Health Initiative Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily 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.
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
Estrogens 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 embolism, stroke, and myocardial infarction 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 WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
The WHIMS estrogen plus progestin ancillary study of the WHI reported an 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) combined with MPA (2.5 mg), 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 MPA therapy 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.
- Tell your doctor about all the medications you take, including any prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
- Your risk for gallbladder disease may be increased with the use of Femring.
- Femring may increase your blood calcium levels.
- Femring may cause vision problems such as retinal vascular thrombosis.
- Tell your doctor if you have blood pressure problems.
- Tell your doctor if you have high cholesterol.
- Tell your doctor if you have thyroid problems.
- Tell your doctor if you are going to have surgery.
- Tell your doctor if you are pregnant or plan to become pregnant.
- Tell your doctor if you are breastfeeding or plan to breastfeed.
Side Effects
Femring can cause side effects. The most common include breast pain, headache, spotting or irregular vaginal bleeding, stomach cramps, bloating, nausea, vomiting, and hair loss. These are not all the possible side effects of Femring. Tell your doctor right away if you experience side effects that are bothersome or won't go away.
Seek medical attention right away if you experience:
- Signs and symptoms of a blood clot such as chest pain, vision problems, breathing problems, cough, pain, swelling, redness, or warmth in the leg
- Signs and symptoms of a stroke such as weakness on one side of your body, trouble breathing, headaches, slurred speech, vision problems
- Signs and symptoms of a heart attack such as chest pain, cold sweats, pain in the left arm, trouble breathing
References:
- Femring Prescribing Information. Rockaway, NJ: Warner Chilcott Inc.; 2005.
- Estradiol acetate vaginal ring (Femring). Cleveland Clinic. Accessed January 30, 2022.
Frequently Asked Questions about Femring (Estradiol Acetate)
What is Femring?
Femring is a vaginal ring that releases a low dose of estrogen (estradiol acetate) to treat menopause symptoms like hot flashes and vaginal dryness.
How does it work?
The ring releases estrogen directly into the bloodstream through the vaginal wall, bypassing the digestive system. This provides steady hormone levels for symptom relief.
Who is it for?
Femring is for women with menopause symptoms, especially those who have a uterus but haven't had it removed (hysterectomy).
What are the different strengths?
Femring comes in two strengths: 0.05 mg and 0.10 mg of estrogen released daily. Your doctor will choose the right one for you.
How do I use it?
Insert the ring into your vagina and gently push it up until it feels comfortable. Leave it in for 3 months, then replace it with a new one.
What are the common side effects?
Side effects may include headache, breast tenderness, vaginal discharge, and mood changes. Most are mild and temporary.
Are there serious risks?
Femring can increase the risk of blood clots, stroke, and breast cancer. Talk to your doctor about your risks and benefits before starting.
Can I use Femring if I have certain conditions?
Femring isn't right for everyone, especially those with a history of blood clots, breast cancer, or liver disease. Discuss your medical history with your doctor.
Can I use Femring while pregnant or breastfeeding?
No, Femring is not safe during pregnancy or breastfeeding.
How can I learn more about Femring?
Talk to your doctor or pharmacist for detailed information and guidance specific to your needs.
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 : 13579
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