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Divigel

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

What is Divigel?

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Estradiol is a form of estrogen, a female sex hormone the 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 purposes other than those listed in this medication guide.

What is the most important information I should know 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.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using Divigel 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.

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 Divigel.

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

Do not use Divigel 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 Divigel, 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 Divigel, 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. Divigel can cause birth defects. Do not use Divigel 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.

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.

To use Divigel:

  1. Wash and dry your hands thoroughly.
  2. Sit in a comfortable position.
  3. Cut or tear the Divigel packet.
  4. Using your thumb and index finger, squeeze the entire contents of the packet onto the skin of the upper thigh.
  5. Gently spread the gel in a thin layer on your upper thigh over an area of about 5 by 7 inches, or two palm prints. It is not necessary to massage or rub in Divigel.
  6. Allow the gel to dry completely before dressing.
  7. Dispose of the empty Divigel packet in the trash.
  8. Wash your hands with soap and water immediately after applying Divigel to remove any remaining gel and reduce the chance of transferring Divigel to other
  9. people.

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

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

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. Symptoms of a Divigel overdose may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using Divigel?

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

Divigel 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, 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 Divigel?

Before using Divigel, 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 Divigel or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect 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 has more information about Divigel 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 Divigel, Estrogel and Estrasorb. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about Divigel, especially if it is new to you.

  • 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 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 06/13/2007 9:14:08 AM.




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