Estradiol topical (for use on skin)

What is the most important information I should know about estradiol topical?

Do not use this medication 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.

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 estradiol topical.

Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. 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 estradiol topical.

What is estradiol topical?

Estradiol is a form of estrogen, a female sex hormone the regulates many processes in the body.

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

Estradiol topical may also be used for purposes other than those listed in this medication guide.

What should I discuss with my health care provider before using estradiol topical?

Do not use estradiol topical if you have:

• a bleeding or blood-clotting disorder;
• 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.

Before using estradiol topical, tell your doctor if you have:

• high blood pressure, angina, or heart disease;
• high cholesterol or triglycerides;
• liver disease;
• kidney disease;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• diabetes;
• depression;
• gallbladder disease; or
• if you have had your uterus removed (hysterectomy).

If you have any of these conditions, you may not be able to use estradiol topical, or you may need a dosage adjustment or special tests during treatment.

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 estradiol transdermal.

Long-term estradiol treatment may increase your risk of stroke. 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.

FDA pregnancy category X. This medication can cause birth defects. Do not use estradiol topical 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. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use estradiol topical?

Use this medication 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.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To use the topical gel (such as Estrogel):

• Prime the pump before using it for the first time. Remove the pump cover and press down on the pump two times. Do not use the gel that comes out of the pump while priming it. Rinse the unused gel away in a sink or wipe it off with a tissue and throw it away in a trash can where children or pets cannot get to it.
• Apply estradiol topical gel at the same time each day. Use the gel only on clean, dry, unbroken skin on the outside of your arm, from wrist to shoulder. Never apply this medicine to the breasts.
• 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.

To use the topical emulsion (such as Estrasorb):

• This medicine is usually applied in the morning. Follow your doctor's instructions.
• Apply this medicine while you are sitting down. You will use two foil pouches each time you apply this medication, unless your doctor has told you otherwise.
• Cut or tear open the foil pouch and place the pouch on top of your left thigh, with the open end of the pouch pointing toward your knee.
• Hold the pouch with one hand and use the fingers of your other hand to gently push all of the medicine out of the pouch and onto your thigh.
• Spend at least 3 minutes rubbing the gel into your entire left thigh and calf. Rub any excess medicine onto your buttocks.
• Cut or tear open the second pouch and apply the medicine to your right leg using the same method described above.
• Do not apply estradiol topical emulsion to skin that is red or irritated.
• Wash your hands with soap and water after applying the emulsion.

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

It is important to use estradiol regularly to get the most benefit.

Store this medication at room temperature away from moisture and heat.

Throw away the Estrogel pump after it has been used to deliver 64 daily doses.

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. Symptoms of an estradiol overdose may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using estradiol topical?

Do not apply sunscreen to your skin at the same time you apply estradiol topical. Sunscreens can affect the amount of estradiol that your skin absorbs.

Avoid getting this medication in your eyes, and rinse throughly 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.

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

What are the possible side effects of estradiol topical?

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, especially on one side of the body;
• sudden headache, confusion, 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.

Other less serious side effects are more likely to occur, such as:

• nausea, vomiting, loss of appetite;
• swollen breasts;
• acne or skin color changes;
• decreased sex drive, impotence, or difficulty having an orgasm;
• migraine headaches or dizziness;
• vaginal pain, dryness, or discomfort;
• swelling of your ankles or feet;
• depression; or
• changes in your menstrual periods, break-through bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect estradiol topical?

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

• St. John's wort;
• phenobarbital (Luminal, Solfoton);
• a blood thinner such as warfarin (Coumadin);
• ritonavir (Norvir);
• carbamazepine (Carbatrol, Tegretol);
• rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
• antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox);

If you are using any of these drugs, you may not be able to use estradiol topical or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estradiol topical. 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 has more information about estradiol topical written for health professionals that you may read.

What does my medication look like?

Estradiol topical is available with a prescription under the brand names Estrogel and Estrasorb. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

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

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 1.02. Revision date: 06/13/2007.