Divigel 1 mg/packet

Generic Name: estradiol topical (for use on skin) (ess tra DYE ol TOP ik al)Brand Names: Divigel 0.25 mg/packet, Divigel 0.5 mg/packet, Divigel 1 mg/packet, Elestrin, Estrasorb, Estrogel, Evamist

What is estradiol topical?

Estradiol is a form of estrogen, a female sex hormone that 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 other purposes not listed in this medication guide.

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. 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 estradiol topical.

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

You should not use estradiol topical 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 this medication. 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 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.

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.

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, and directions for priming the spray or gel pump if needed. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply estradiol topical 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 the topical gel (such as Estrogel):

• Apply estradiol topical gel to the outside of your arm, from wrist to shoulder. 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.

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

To use the topical emulsion (such as Estrasorb):

• 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.

To use the topical spray (such as Evamist):

• 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.

Wash your hands with soap and water after applying the gel or emulsion.

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

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

Store this medication 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 estradiol topical?

Do not apply sunscreen to your skin at the same time you apply estradiol topical. Avoid getting this medication 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.

Estradiol topical 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 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. 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 estradiol topical?

Tell your doctor about all other medications you use, especially:

• 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 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 can provide more information about estradiol topical.

• 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 1996-2006 Cerner Multum, Inc. Version: 2.04. Revision Date: 06/11/2009 1:16:40 PM.