Consumer Information

Elestrin

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

What is Elestrin?

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Elestrin is estradiol 0.06% in a colorless, non-staining gel supplied in a non-aerosol, metered-dose pump container. Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Elestrin is used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

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

What is the most important information I should know about Elestrin?

Do not use Elestrin 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. Elestrin 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 this treatment.

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

Before using Elestrin

You should not use Elestrin 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 Elestrin. 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 Elestrin 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 this medication. Estradiol can pass into breast milk and may harm a nursing baby. Elestrin 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 Elestrin.

How should I use Elestrin?

Use Elestrin 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.

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

Apply Elestrin only to clean, dry, unbroken skin. Do not apply to skin that is red or irritated. Never apply this medicine to the breasts.
Elestrin is applied once daily to the upper arm using a metered-dose pump which delivers 0.87 gram of Elestrin gel per actuation. Dosage should be started with the lowest effective dose of Elestrin, which is one pump per day. Subsequent dosage adjustment may be made based upon the response. This dose should be periodically reassessed by the healthcare provider. Use the gel at the same time each day.
Do not rub the gel in, but allow it to dry on your skin for at least 5 minutes before you dress.
Wash your hands with soap and water after applying the gel.

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

Store Elestrin at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication 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, stomach pain, breast tenderness, drowsiness, and vaginal bleeding.

What should I avoid while using Elestrin?

Do not apply sunscreen to your skin at the same time you apply Elestrin. Sunscreens can affect the amount of Elestrin that your skin absorbs. Avoid getting Elestrin in your eyes, and rinse thoroughly with water if this does happen.

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

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

Elestrin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 Elestrin 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 side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Elestrin?

Before using Elestrin, 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), ketoconazole (Nizoral), or itraconazole (Sporanox), or rifampin (Rifadin, Rifater, Rifamate, Rimactane).

This list is not complete and there may be other drugs that can interact with Elestrin. 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 Elestrin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Elestrin only for the indication prescribed.
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.