Generic Name: estradiol (Vaginal route)
Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, 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 possible .Vaginal route(Insert, Extended Release)
Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogen alone have been reported. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogens combined with progestins have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported in women receiving estrogen alone or estrogen combined with progestins. Risks should be assumed to be similar for other doses, 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 possible .Vaginal route(Tablet)
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens and 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. The Women's Health Initiative (WHI) reported increased risks of stroke and DVT with the use of estrogen-alone therapy and increased risks of stroke, DVT, pulmonary embolism, myocardial infarction, and invasive breast cancer with the use of estrogen plus progestin. In addition, the WHI memory study reported an increased risk of probable dementia in postmenopausal women 65 years of age and older who used estrogen alone or in combination with progestin therapy. Estrogen therapy with or without progestins should not be used for the prevention of cardiovascular disease or dementia, and should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman .Vaginal route(Insert, Extended Release)
Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. 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 .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
- Insert, Extended Release
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Estrogen
Uses For Vagifem
Estradiol vaginal is a medicine that contains an estrogen hormone. It is used to treat changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by low estrogen levels or menopause.
This medicine is available only with your doctor's prescription.
Before Using Vagifem
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Use of Vagifem® vaginal tablet is not indicated for children.
Although appropriate studies on the relationship of age to the effects of Vagifem® vaginal tablets have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, strokes, or dementia, which may require caution in patients receiving this medicine.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Tranexamic Acid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Eslicarbazepine Acetate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mycophenolate Mofetil
- Mycophenolic Acid
- St John's Wort
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Blood clots (e.g., deep vein thrombosis, pulmonary embolism), active or history of or
- Breast cancer, known or suspected, or a history of or
- Heart attack, history of or
- Liver disease or
- Protein C, protein S, or other known blood clotting disorders or
- Stroke, history of or
- Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.
- Angioedema or anaphylaxis—Should not be used in patients who have experienced these conditions with prior Vagifem® use.
- Asthma or
- Diabetes or
- Edema (fluid retention or body swelling) or
- Endometriosis or
- Epilepsy (seizures) or
- Gallbladder disease or
- Hereditary angioedema (swelling of the face, lips, tongue, or throat) or
- Hypercalcemia (high calcium in the blood) or
- Hypocalcemia (low calcium in the blood) or
- Hypothyroidism (an underactive thyroid) or
- Hypertriglyceridemia or
- Jaundice during pregnancy or from using hormonal therapy in the past or
- Liver tumors or
- Migraine headache or
- Porphyria (an enzyme problem) or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
- Heart disease or
- Hypertension (high blood pressure) or
- Hypercholesterolemia (high cholesterol or fats in the blood) or
- Obesity, or history of or
- Prolonged periods of immobilization—Use with caution. These conditions may increase risk for more serious side effects.
Proper Use of estradiol
This section provides information on the proper use of a number of products that contain estradiol. It may not be specific to Vagifem. Please read with care.
It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.
This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.
To use the vaginal tablet:
- The tablet should be used only in your vagina. Do not swallow the tablet.
- Each vaginal tablet comes packaged inside an applicator. Do not take the tablet out of the applicator. If the tablet comes out of the applicator but has not fallen out of the package, carefully put it back into the applicator for insertion. If the tablet falls out of the applicator, throw it away and use a new applicator that still has the tablet inside it.
- Keep your hands clean and dry while handling the tablet.
- Take the applicator out of the plastic wrap before using it.
- Use the applicator only one time and then throw it away. Use a new applicator for each dose.
- Most women will start by inserting a new tablet every day for two weeks, then change to inserting a new tablet only 2 days each week. Carefully follow the schedule that your health caregiver tells you to.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For vaginal dosage form (tablet):
- For treatment of atrophic vaginitis caused by menopause:
- Adults—10 microgram (mcg) or one tablet inserted into the vagina once a day for 2 weeks, followed by one tablet twice weekly.
- Children—Use is not recommended.
- For treatment of atrophic vaginitis caused by menopause:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Vagifem
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.
It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medication may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Talk with your doctor about this risk. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine. Check with your doctor immediately if your experience abnormal vaginal bleeding.
Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.
Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes or are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before you have surgery or if you need to stay in bed for an extended time. This medicine may affect the results of certain medical tests.
Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
Vagifem Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common
- Vaginal yeast infection
- Change in vaginal discharge
- clear or bloody discharge from the nipple
- decrease in the amount of urine
- dimpling of the breast skin
- fast heartbeat
- inverted nipple
- joint pain, stiffness, or swelling
- lump in the breast or under the arm
- noisy, rattling breathing
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm or leg
- persistent crusting or scaling of the nipple
- redness of the skin
- redness or swelling of the breast
- shortness of breath
- sore on the skin of the breast that does not heal
- swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs
- tightness in the chest
- troubled breathing at rest
- troubled breathing or swallowing
- vaginal bleeding
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Abdominal or stomach pain
- back pain
- itching or pain of the vagina or genital area
- thick, white vaginal discharge with mild or no odor
- weight gain
- Body aches or pain
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- Feeling sad or empty
- headache, severe and throbbing
- hives or welts
- lack of appetite
- trouble concentrating
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Vagifem Vaginal side effects (in more detail)
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