Estrace Vaginal

Name: Estrace Vaginal

Commonly used brand name(s)

In the U.S.

  • Estrace
  • Estring
  • Femring
  • Vagifem

Available Dosage Forms:

  • Tablet
  • Cream
  • Insert, Extended Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Estrogen

Uses For Estrace

Estradiol vaginal ring and insert are used to treat changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by low estrogen levels or menopause.

Estradiol vaginal ring is also used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen. The hormone from the vaginal ring is absorbed through your vagina. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (hot flashes) in women during menopause.

This medicine is available only with your doctor's prescription.

Before Using Estrace

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:

Allergies

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.

Pediatric

Use of estradiol vaginal ring and inset is not indicated for children.

Geriatric

Although appropriate studies on the relationship of age to the effects of estradiol vaginal ring and insert 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 estradiol vaginal ring and tablet.

Pregnancy

Pregnancy Category Explanation
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.

Breast Feeding

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.

  • Aprepitant
  • Bosentan
  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Conivaptan
  • Dabrafenib
  • Darunavir
  • Dexamethasone
  • Donepezil
  • Eliglustat
  • Enzalutamide
  • Fosphenytoin
  • Griseofulvin
  • Idelalisib
  • Isotretinoin
  • Lesinurad
  • Lixisenatide
  • Lumacaftor
  • Mitotane
  • Modafinil
  • Netupitant
  • Oxcarbazepine
  • Phenytoin
  • Pitolisant
  • Pixantrone
  • Prednisone
  • Rifabutin
  • Rifampin
  • St John's Wort
  • Sugammadex
  • Theophylline
  • Tizanidine
  • Topiramate
  • Valproic Acid

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.

  • Alprazolam
  • Amprenavir
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Clarithromycin
  • Colesevelam
  • Cyclosporine
  • Delavirdine
  • Efavirenz
  • Fosamprenavir
  • Fosaprepitant
  • Ginseng
  • Ketoconazole
  • Lamotrigine
  • Levothyroxine
  • Licorice
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Prednisolone
  • Rifapentine
  • Ritonavir
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • Tacrine
  • Telaprevir
  • Tipranavir
  • Troglitazone
  • Troleandomycin
  • Voriconazole
  • Warfarin

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.

  • Caffeine

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 (eg, deep vein thrombosis, pulmonary embolism), active or history of or
  • Breast cancer, known or suspected, or a history of or
  • Heart attack, active or history of or
  • Liver disease or
  • Protein C, protein S, or other known blood clotting disorders or
  • Stroke, active or history of or
  • Surgery with a long period of inactivity 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 use of estradiol vaginal ring and insert.
  • Asthma or
  • Cancer, history of 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
  • Hypertension (high blood pressure) or
  • Hypertriglyceridemia (high triglycerides or fats in the blood) or
  • Hypocalcemia (low calcium in the blood) or
  • Hypothyroidism (an underactive thyroid) 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.

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 Estrace. 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 is to be used only in the vagina. Use at bedtime unless your doctor tells you otherwise.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To use the vaginal ring:

  • This medicine is contained in a ring that you or your caregiver will put into your vagina. The ring will slowly release small amounts of medicine 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.
  • Once the ring is in place in your vagina, you should not be able to feel it. If you feel uncomfortable, the ring may not be inserted far enough. Gently push the ring farther into your vagina. If you feel pain, talk to your doctor.
  • You will leave the ring in for 90 days (3 months), unless your doctor tells you a different schedule. After that time, remove the ring and insert a new one. If you forget to remove the ring after 90 days, call your doctor for instructions.
  • The ring may move down into the lower part of your vagina accidently. This can happen if you strain to have a bowel movement. 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. Call your doctor if the ring comes out several times.
  • If you need to remove the ring, hook your finger through the ring and pull it out.

To use the vaginal insert:

  • 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.

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.

Dosing

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 (ring):
    • For atrophic vaginitis, hot flashes, and other symptoms caused by menopause:
      • Adults—One vaginal ring inserted into the vagina for 3 months. Your doctor may adjust your dose as needed.
      • Children—Use is not recommended.
  • For vaginal dosage form (insert):
    • For treatment of atrophic vaginitis caused by menopause:
      • Adults—10 microgram (mcg) or one insert into the vagina once a day for 2 weeks, followed by one insert twice weekly.
      • Children—Use is not recommended.

Missed Dose

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.

Storage

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.

Wrap the used vaginal ring in tissue and throw it in the trash can. Do not flush the vaginal ring down the toilet.

Uses

This medication is a female hormone. It is used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.

How to use Estrace Cream With Applicator

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication as directed by your doctor. Fill the applicator with the medication according to the directions. Insert the applicator high into the vagina and press the plunger to release the medication. Clean the applicator with warm soapy water and rinse well. Do not boil or use hot water to clean the applicator.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. Follow your dosing schedule carefully. Do not increase your dose or use this medication more often or for a longer time than directed.

Tell your doctor if your condition does not improve or if it worsens.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, mental/mood disorders (such as dementia, depression), certain blood disorder (porphyria).

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using an estrogen product. You may need to stop this medication for a time or take special precautions.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

Some estrogen products contain mineral oil which can weaken rubber products such as latex condoms, cervical caps, and diaphragms and lead to their failure. Consult your pharmacist if you are unsure if your product contains mineral oil. If it does, talk to your doctor about other birth control products (such as polyurethane condoms) while you are using this medication.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

What is Estrace?

Estrace tablets contains estradiol, a form of estrogen. Estradiol is a female sex hormone produced by the ovaries that regulates many processes in the body.

Estrace is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body.

Estrace is sometimes used as part of cancer treatment in women and men.

Estrace is also available as a cream.

Before taking this medicine

You should not use Estrace if you are allergic to estradiol, if you are pregnant, or if you have:

  • unusual vaginal bleeding that a doctor has not checked;

  • liver disease;

  • a bleeding or blood-clotting disorder;

  • a recent history of heart attack or stroke;

  • a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer);

  • if you have ever had a blood clot (especially in your lung or your lower body); or

  • if you are allergic to any medicines or food dyes.

Estrace should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure Estrace is safe for you, tell your doctor if you have:

  • heart disease;

  • risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease);

  • a history of jaundice caused by pregnancy or birth control pills;

  • a thyroid disorder;

  • kidney disease;

  • asthma;

  • epilepsy or other seizure disorder;

  • migraines;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • endometriosis or uterine fibroid tumors;

  • gallbladder disease;

  • high or low levels of calcium in your blood; or

  • if you have had your uterus removed (hysterectomy).

Long-term use of Estrace may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Estrace long term.

Do not use Estrace if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

Estradiol can pass into breast milk. Estrace may slow breast milk production. Tell your doctor if you are breast-feeding a baby.

Estrace side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Estrace: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs;

  • swelling or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes);

  • unusual vaginal bleeding;

  • a lump in your breast;

  • fluid retention (swelling, rapid weight gain); or

  • high levels of calcium in your blood - nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Common Estrace side effects may include:

  • breast pain;

  • headache;

  • vaginal itching or discharge, changes in your menstrual periods, light vaginal bleeding or spotting;

  • thinning scalp hair; or

  • nausea, vomiting, bloating, stomach cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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