Consumer Information

Evamist

Generic Name: estradiol topical (for use on skin) (ess tra DYE ol TOP ik al)
Brand Names: Divigel, Elestrin, Estrasorb, Estrogel, Evamist spray

What is Evamist?

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Evamist is a transdermal spray containing estradiol. Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body. Each spray delivers 90 mcL which contains 1.53 mg of estradiol.

Evamist is used for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.

Evamist may also be used for other purposes not listed in this medication guide.

Important information about Evamist

Do not use Evamist if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a bleeding disorder, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue treatment with Evamist.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Evamist.

Before using Evamist

You should not use Evamist if you have:
  • a bleeding or blood-clotting disorder;

  • liver or kidney disease;

  • a history of stroke or circulation problems;

  • abnormal vaginal bleeding that a doctor has not checked; or

  • any type of breast, uterine, or hormone-dependent cancer.

If you have certain conditions, you may need a dose adjustment or special tests to safely use Evamist. Tell your doctor if you have:

  • high blood pressure, angina, or heart disease;

  • high cholesterol or triglycerides;

  • kidney disease;
  • asthma;

  • epilepsy or other seizure disorder;

  • migraines;

  • diabetes;

  • depression;

  • gallbladder disease; or

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

FDA pregnancy category X. This medication can cause birth defects. Do not use Evamist if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using Evamist. Estradiol can pass into breast milk and may harm a nursing baby. Evamist may also slow breast milk production. Do not use if you are breast-feeding a baby.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using Evamist.

How should I use Evamist?

Use Evamist exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Evamist comes with patient instructions for safe and effective use, and directions for priming the spray pump if needed. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply Evamist only to clean, dry, unbroken skin. Do not apply to skin that is red or irritated. Never apply this medicine to the breasts.

To use Evamist topical spray:

  • Apply the spray to the skin on the inside of your forearm, just below the elbow. Use the spray at the same time each day.

  • Place the cone of the spray applicator directly to your skin and hold the pump upright. Press the pump fully one spray. If your doctor has prescribed more than one spray, choose a different place on your inside forearm for the second spray. Use only the number of sprays your doctor has recommended.

  • Do not rub the spray in, but allow it to dry on your skin for at least 2 minutes before you dress. Do not wash your arm for at least 30 minutes after applying the spray.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Evamist.

Store Evamist at room temperature away from moisture and heat.

What happens if I miss a dose?

Use Evamist as soon as you remember. If your next dose is less than 12 hours away, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using Evamist?

Do not apply sunscreen to your skin at the same time you apply Evamist. Avoid getting this medication in your eyes, and rinse thoroughly with water if this does happen.

Avoid allowing other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.

Grapefruit and grapefruit juice may interact with estradiol and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

This medication is flammable. Avoid smoking or being near an open flame until the medicine has dried completely.

Evamist side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Evamist: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;

  • pain or swelling in your lower leg;

  • abnormal vaginal bleeding;

  • pain, swelling, or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes); or

  • a lump in your breast.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;

  • swollen breasts;

  • acne or skin color changes;

  • vaginal pain, dryness, or discomfort, decreased sex drive, impotence, or difficulty having an orgasm;

  • swelling, weight gain;

  • migraine headaches, dizziness, depression; or

  • break-through bleeding, vaginal itching or discharge.

This is not a complete list of Evamist 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.

What other drugs will affect Evamist?

Before using Evamist, tell your doctor if you are using any of the following drugs:

  • St. John's wort;

  • a blood thinner such as warfarin (Coumadin);

  • ritonavir (Norvir);

  • carbamazepine (Carbatrol, Tegretol), or phenobarbital (Luminal, Solfoton);

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), or rifampin (Rifadin, Rifater, Rifamate, Rimactane).

  • an antifungal medication such as ketoconazole (Nizoral) or itraconazole (Sporanox).

This list is not complete and there may be other drugs that can interact with Evamist. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Evamist.
  • Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
Copyright 1996-2009 Cerner Multum, Inc. Version: 2.04. Revision Date: 06/11/2009 1:16:40 PM.

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