Divigel

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

What is Divigel?

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Divigel (estradiol gel) is a clear, colorless gel, which is odorless when dry. Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

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

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

Important information about Divigel

Do not use Divigel 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. Divigel 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 with Divigel.

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 Divigel 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 Divigel.

Before using Divigel

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 Divigel 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 Divigel 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 Divigel. 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. Divigel can cause birth defects. Do not use this medication 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 Divigel. Estradiol can pass into breast milk and may harm a nursing baby. Divigel 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 Divigel.

How should I use Divigel?

Use Divigel 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.

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

• Apply Divigel only to clean, dry, unbroken skin. Do not apply to skin that is red or irritated.

• Divigel should be applied once daily on the skin of either the right or left upper thigh. The application surface area should be about 5 by 7 inches (approximately the size of two palm prints). Use the gel at the same time each day.

• The entire contents of a unit dose packet should be applied each day. To avoid potential skin irritation, Divigel should be applied to the right or left upper thigh on alternating days.

• Divigel should not be applied on the face, breasts, or irritated skin or in or around the vagina. Contact of the gel with eyes should be avoided.

• After application, the gel should be allowed to dry before dressing. The application site should not be washed within 1 hour after applying Divigel.

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 Divigel.

Store Divigel 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 Divigel?

Do not apply sunscreen to your skin at the same time you apply Divigel. 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.

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

Divigel side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Divigel: 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 Divigel 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 Divigel?

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 Divigel. 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 Divigel.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Divigel 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 1996-2009 Cerner Multum, Inc. Version: 2.04. Revision Date: 06/11/2009 1:16:40 PM.

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