Divigel

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

What is Divigel?

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 purposes not listed in this medication guide.

Important information

You should not use Divigel if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), a bleeding or blood-clotting disorder, liver disease, abnormal vaginal bleeding, history of an allergic reaction to estradiol topical, or a hormone-related cancer such as breast or uterine cancer.

Divigel can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Do not use Divigel if you are breast-feeding a baby. Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the Divigel was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts. Children should avoid coming into contact with skin areas where you have applied Divigel. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Slideshow: Flashback: FDA Drug Approvals 2013

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.

Before using Divigel

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 history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

  • liver disease;

  • a bleeding or blood-clotting disorder;

  • unusual vaginal bleeding that has not been checked by a doctor;

  • any type of breast, uterine, or hormone-dependent cancer; or

  • if you have ever had an allergic reaction to estradiol topical.

To make sure you can safely use Divigel, tell your doctor if you have any of these other conditions:

  • high blood pressure, angina, or heart disease;

  • high cholesterol or triglycerides;

  • kidney disease;

  • asthma;

  • hereditary angioedema;

  • epilepsy or other seizure disorder;

  • migraines;

  • endometriosis;

  • diabetes;

  • a thyroid disorder;

  • depression;

  • porphyria;

  • lupus;

  • gallbladder disease; or

  • low levels of calcium in your blood.

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.

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.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions 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. Avoid allowing other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water. Children should avoid coming into contact with skin areas where you have applied Divigel. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

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?

If you are less than 12 hours late in using your medicine, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, breast tenderness, drowsiness, and vaginal bleeding.

What should I avoid?

Do not apply sunscreen to your skin at the same time you apply Divigel. Avoid getting this medication in your eyes. If this does happen, rinse with water.

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

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. Stop using Divigel and call your doctor at once if you have a serious side effect such as:

  • 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, swelling, warmth, or redness in one or both legs;

  • abnormal vaginal bleeding;

  • pain, swelling, or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes); or

  • a lump in your breast.

Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

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, 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.

See also: Side effects (in more detail)

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, Jantoven);

  • ritonavir (Norvir, Kaletra);

  • carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Luminal, Solfoton);

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or rifampin (Rifadin, Rifater, Rifamate, Rimactane).

  • an antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or itraconazole (Sporanox).

This list is not complete and other drugs may interact with Divigel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Divigel.
  • Disclaimer: 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 1996-2014 Cerner Multum, Inc. Version: 7.01. Revision Date: 2012-06-13, 1:50:54 PM.

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