Estrace Vaginal

1 What is Estrace Vaginal?

Brand: Estrace, Estring, Femring, Vagifem

Generic: Estradiol (Vaginal Route)

Estradiol vaginal ring and tablet are hormone replacements used for the treatment of changes in and around the vagina such as vaginal dryness, itching, and burning caused by low estrogen levels or menopause. The hormone from the vaginal ring is absorbed through your vagina to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen.

This drug works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating in women during menopause. This drug requires a prescription.

2 What to Know Before Using

Before using Estrace Vaginal, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Use of estradiol vaginal ring and tablet is contraindicated for children. Studies in the elderly have not reported any geriatric-specific problems.

Caution is required for elderly patients taking this drug since they are more likely to have breast cancer, strokes, or dementia. Fetal abnormalities have been reported in studies of pregnant women and animals while taking this drug.

This drug is contraindicated in women who are or may become pregnant because the risk clearly outweighs any possible benefit. This drug may alter milk production or composition, and you should monitor the infant for side effects and adequate milk intake if an alternative to this drug is not prescribed.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as Tranexamic Acid, Bupropion, Carbamazepine, Ceritinib, Crizotinib, Dabrafenib, Darunavir, Dasabuvir, Donepezil, Eliglustat, Fentanyl, Idelalisib, Isotretinoin, Lumacaftor, Nilotinib, Piperaquine, Pixantrone, Sugammadex, Theophylline, Tizanidine, Topotecan, Alprazolam, Amprenavir, Aprepitant, Atazanavir, Bacampicillin, Betamethasone, Bexarotene, Bosentan, Clarithromycin, Colesevelam, Cyclosporine, Delavirdine, Efavirenz, Etravirine, Fosamprenavir, Fosaprepitant, Fosphenytoin, Ginseng, Griseofulvin, Ketoconazole, Lamotrigine, Levothyroxine, Licorice, Modafinil, Mycophenolate, Mofetil, Mycophenolic Acid, Nelfinavir, Oxcarbazepine, Phenobarbital, Phenytoin, Prednisolone, Primidone, Rifabutin, Rifampin, Rifapentine, Ritonavir, Rosuvastatin, Rufinamide, Selegiline, St John's Wort, Tacrine, Telaprevir, Tipranavir, Topiramate, Troglitazone, Troleandomycin, Voriconazole, or Warfarin.

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as abnormal or unusual vaginal bleeding, blood clots, breast cancer, history of heart attack, liver disease, blood clotting disorders, stroke, surgery with a long period of inactivity, tumors, angioedema, epilepsy, gallbladder disease, hereditary angioedema, hypercalcemia, hypertension, hypertriglyceridemia, hypocalcemia, hypothyroidism, jaundice during pregnancy or from using hormonal therapy in the past, liver tumors, migraine headache, porphyria, or systemic lupus erythematosus.

3 Proper Usage

To use Estrace Vaginal correctly, you must follow all instructions given by your doctor.

This drug must be taken exactly as directed by your healthcare professional. To prevent any side effects, take this drug exactly as directed in the label or as prescribed by your healthcare professional.

This drug is to be used only in the vagina during bedtime unless your healthcare professional tells you otherwise. This drug is stored in a ring that you or your caregiver will put into your vagina. The ring will slowly release small amounts of drug for your body to absorb.

Your caregiver will show you how to insert the ring. Remove the ring from the sealed pouch until you are ready to use it. You should not be able to feel it once the ring is in place in your vagina. The ring may not be inserted far enough to prevent any uncomfortable feelings. Consult with your healthcare professional if you feel pain. The ring will be left inside for 90 days.

Remove the ring and insert a new one after 90 days. If you strain hard during bowel movement the ring may accidentally move down into the lower part of your vagina.

Use your finger to gently push the ring back into place. If the ring comes all the way out of your vagina, rinse it off with warm water and put it back in. If you need to remove the ring, hook your finger through the ring and pull it out. The tablet should be used only in your vagina.

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 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.

Eat grapefruit or drink grapefruit juice is not recommended while you are using this drug as it interferes with the absorption of this drug. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. Adults with atrophic vaginitis, hot flashes, and other symptoms caused by menopause are prescribed with one vaginal ring to be inserted into the vagina for 3 months.

Use in children is not recommended. Adults atrophic vaginitis caused by menopause are prescribed 10 microgram or one tablet to be inserted into the vagina once a day for 2 weeks, followed by one tablet twice weekly. Use in children is not recommended. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs. Wrap the used vaginal ring in tissue and throw it in the trash can. Do not flush the vaginal ring down the toilet.

4 Precautions to Take

In using Estrace Vaginal, you must be careful and take some precautions as advised by your doctor.

Your healthcare provider should closely monitor the effectiveness of this drug as well as check for unwanted effects. Unwanted effects can be detected using pelvic exam, breast exam, and mammogram.

Pregnancy is very unlikely in postmenopausal women but it is important to note that this drug has teratogenic effects. Increased risk for having blood clots, strokes, or heart attacks have been associated with this drug.

This risk may continue even after you stop using the drug and this risk is amplified if you have hypertension, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes.

Contact emergency medical services immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak. Risks of breast cancer, endometrial cancer, or uterine cancer are increased with prolonged use of this drug.

Consult with your healthcare professional about the risk and benefits of this drug and if you should also use a progestin drug if you still have your uterus. Inform your healthcare professional immediately if you have unusual vaginal bleeding.

Women 65 years of age and older taking this drug may have increase risks of dementia. Before any kind of surgery or emergency treatment, inform the medical doctor or dentist in charge that you are using this drug. This drug may also affect the results of certain medical tests.

Consult with your healthcare professional immediately if you experience severe headache or sudden loss of vision or any other change in vision occurs while you are taking this drug. You may be referred to an ophthalmologist to have your eyes checked. Inform your healthcare professional of any problems with your vagina, such as having an unusually shaped or narrow vagina. Tell your doctor if you have problems with your reproductive organs, bladder, rectum, or pelvic area.

Consult with your healthcare professional before drinking grapefruit juice, or take any other prescription or non-prescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Estrace Vaginal.

Side effects may vary for each individual and prompt medical attention should be given if they occur. Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as 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, fever, hives, itching, or rash, hoarseness, inverted nipple, irritation, 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, 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, or symptoms of overdose such as abdominal or stomach pain, dizziness, drowsiness, nausea or vomiting, tenderness of the breasts, unusual tiredness or weakness. Some side effects may occur that usually do not need medical attention.

As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects. If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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