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.
Imvexxy (Estradiol)
Prescription Required
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Product Details
Description
Imvexxy (estradiol vaginal inserts) is an estrogen prescribed to treat moderate to severely painful intercourse caused by menopause.
Imvexxy is available in vaginal inserts that contain 4 mcg or 10 mcg estradiol.
Fact Table
Formula
C18H24O2
License
US FDA
Bioavailability
Local (vaginal); systemic absorption minimal
Legal status
Prescription only (Rx)
Chemical Name
Estradiol
Elimination half-life
~6-9 hours (systemic, when absorbed)
Dosage (Strength)
4 mcg, 10 mcg vaginal inserts
Pregnancy
Not recommended
Brands
Imvexxy
Protein binding
98%
PubChem CID
5757
MedlinePlus
a682922
ChEBI
CHEBI:16469
ATC code
G03CA03
DrugBank
DB00783
KEGG
D00055
Routes of administration
Vaginal
Directions
Use Imvexxy as directed by your doctor.
Recommended Imvexxy dosage: One vaginal insert once a day for two weeks, then one insert twice a week.
Keep Imvexxy inserts stored between 20°C and 25°C (68°F and 77°F) and out of children’s reach.
For additional information regarding the use of Imvexxy, refer to the medication guide that comes with the prescription.
If you have any questions or concerns, contact your doctor or pharmacist.
Ingredients
The active ingredient in Imvexxy is estradiol.
Inactive ingredients include ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide.
Contraindications
Patients with any of the following should not use Imvexxy:
- Abnormal vaginal bleeding that is not diagnosed
- Active or history of breast cancer
- Cancer that is dependent on estrogen
- Active or history of blood clots
- Active or history of arterial thromboembolic conditions such as heart attack or stroke
- Allergic reactions, angioedema, or anaphylactic reactions to Imvexxy
- Liver problems or disease
- Protein C, protein S, antithrombin deficiency, or other known blood clotting disorders
Cautions
- Imvexxy is associated with the following FDA Boxed Warning:
- Estrogen-alone
- Women with a uterus who uses estrogens are at increased risk of endometrial cancer
- Increased risks of stroke and blood clots were reported in the Women’s Health Initiative (WHI) estrogen-alone substudy
- Postmenopausal women who were 65 years of age and older had an increased risk of probable dementia in the WHI Memory Study estrogen-alone ancillary study (WHIMS)
- Estrogen should not be used by itself to prevent cardiovascular disease or dementia
- Estrogen plus progestin
- Increased risks of stroke, blood clots, and heart attack were reported in the WHI estrogen plus progestin substudy
- Increased risks of invasive breast cancer were reported in the WHI estrogen plus progestin substudy
- Postmenopausal women who were 65 years of age and older had an increased risk of probable dementia in the WHIMS estrogen plus progestin ancillary study of WHI
- Estrogen plus progestin should not be used to prevent cardiovascular disease or dementia
- Before you start treatment with Imvexxy, inform your doctor of:
- All the prescription and over-the-counter medications you take
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Imvexxy is associated with the following warnings and precautions:
- Increased risk of gallbladder disease
- High blood calcium levels, vision loss, severely high triglyceride levels in the blood, or cholestatic jaundice; Imvexxy should be stopped if any these occur
- Thyroid problems
Side Effects
Headache is the most common Imvexxy side effect. However, patients may experience other side effects; therefore, inform your doctor of any side effects that bother you or won’t go away.
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Reference
Imvexxy. Boca Raton, FL: TherapeuticsMD, Inc.; 2021.
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 : 14587
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