Vagifem and/or Equivalent Estradiol Prescription Information
Vagifem is an Estradiol-Containing Vaginal tabletfor the management of Atrophic Vaginitis resulting from estrogen deficiencies in postmenopausal women. Each Vagifem tablet contains natural estrogen and is administered intra-vaginally with the help of a disposable applicator.
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Vagifem is approved for the treatment of atrophic vaginitis in estrogen deficient women. It is also prescribed to women for various menopausal vaginal symptoms like vaginal burning sensations, vaginal dryness, and vaginal itching. All such symptoms result from the suppressed production of estrogen in post-menopausal women post. Vagifem is also used as an estrogen replacement therapy.
Dose, Administration and Dosage forms:
Vagifem is manufactured in film-coated vaginal tablet formulation. Each Vagifem tablet contains 25.8g of estradiol hemihydrate which is equivalent to 25g of estradiol along with various inactive tablet fillers like hypromellose, lactose monohydrate, PEG, starch and magnesium stearate. These tablets are administered vaginally with the help of a disposable applicator.
The starting dose for Vagifem is one tablet inserted vaginally once daily for two weeks. After this starting duration, the maintenance dose is one tablet twice per week. This dose may vary based on the patient's medical condition and response to initial dosages. These tablets should be stored at room temperature (15C-30 C).
Mechanism of action:
The estradiol in Vagifem is chemically and biologically similar to the endogenous human estrogen, and as such, Vagifem's mechanism of action is similar to that of the human endogenous estrogen. It acts on estrogen receptors by agonistic action. Estradiol diffuses through cell membranes in tissues of the reproductive tract and activates the estrogen receptors as it binds to them. This estrogen receptor activation results in estrogen regulated growth, differentiation, and functioning, thus balancing the lack of endogenous estrogen concentrations in postmenopausal women.
Side-effects and safety profile:
Various side-effects reported with Vagifem include vaginal spotting; abnormal vaginal discharge; vaginal pain and discomfort; vaginitis; allergic reactions like skin rashes; genital pruritus; headaches; fluid retention; upper respiratory tract infections; sinusitis; haematuria; bronchitis; dyspepsia; hot flashes; sleep problems like insomnia; sleeplessness, etc. Patients experiencing any of the above side-effects should immediately consult with a physician.
Vagifem carries a black box warning of enhanced risks of endometrial cancer in postmenopausal women when Vagifem is used for more than one year.
Vagifem has been reported to cause persistent abnormal vaginal bleeding.
Reports indicate that Vagifem may be connected to increased possibilities of cancer of the breast, cervix, and liver.
Estrogen therapy may cause a massive elevation of triglyceride levels which may cause pancreatitis.
Recent studies have shown that Vagifem increases the risks of surgically confirmed gallbladder disease in postmenopausal women.
Patients must discuss any history of medical conditions such as asthma, seizures, migraines, heart failure and renal dysfunction with the prescribing physician as Vagifem may increase chances of fluid retention.
Pregnant women: Vagifem should not be prescribed during pregnancy or immediately postpartum.
Nursing women: Vagifem should not be prescribed to nursing women as it decreases both quantity as well as quality of the milk, as the estrogen will excrete through the breast milk. Vagifem should not be prescribed as a prevention therapy for postpartum breast engorgement.
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