Divigel (Transdermal)
Estradiol topical (for the skin) is used in menopausal adult women to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.
Estradiol topical may also be used for purposes not listed in this medication guide.
uses
What is Divigel (Transdermal) used for?
- Atrophic Urethritis
- Atrophic Vaginitis
- Hypoestrogenism
- Oophorectomy
- Postmenopausal Symptoms
- Primary Ovarian Failure
- Prostate Cancer
- Breast Cancer--Palliative
- Prevention of Osteoporosis
warnings
What is the most important information I should know about Divigel (Transdermal)?
You should not use estradiol if you are allergic to it or any of its ingredients, or if you have or have ever had:
- unusual vaginal bleeding that has not been checked by a doctor;
- a heart attack, stroke, or blood clot;
- a bleeding or blood clotting disorder;
- hormone related cancer such as breast or uterine cancer; or
- liver disease.
Estradiol should not be used to prevent heart disease, stroke, or dementia. Using this medicine may increase your risk of blood clots, dementia, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.
Tell your doctor if you have or have ever had:
- heart disease;
- gallbladder disease;
- asthma;
- epilepsy or other seizure disorder;
- migraines;
- bone cancer;
- a family history of breast cancer;
- systemic lupus erythematosus (SLE);
- diabetes;
- endometriosis or uterine fibroid tumors;
- hereditary angioedema;
- porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
- high triglycerides;
- a thyroid disorder;
- hypoparathyroidism;
- abnormal levels of calcium in your blood;
- endometrial hyperplasia (overgrowth of cells lining the uterus);
- if you have had your uterus removed (hysterectomy);
- liver problems such as a liver tumor or jaundice (caused by pregnancy or hormones); or
- kidney disease.
Long-term use of estradiol may increase your risk of cancer of the breast or uterus. Talk with your doctor about this risk.
Do not use estradiol topical if you are pregnant. Tell your doctor right away if you become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Divigel (Transdermal)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Estradiol topical can increase your risk of blood clots, stroke, or heart attack. Get emergency medical help if you have: chest pain, pain, swelling or warmth in your leg, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath or trouble breathing.
Call your doctor at once if you have:
- change in the pattern or severity of migraine headaches;
- memory problems, confusion, unusual behavior;
- unusual vaginal bleeding;
- a lump in your breast;
- changes in vision;
- abnormal lab results such as increased fat in your blood (triglycerides) or thyroid hormone levels;
- signs of gallbladder, liver, or pancreas problems--chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, loss of appetite, upper stomach pain (that may spread to your back), vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
- fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
- increased blood pressure-- severe headache, pounding in your neck or ears; or
- low or high blood calcium levels--constipation, increased thirst or urination, muscle spasms, weight loss, tingly feeling (around your mouth, or in your fingers and toes).
Topical estradiol is absorbed through the skin of a child who comes into contact with this medicine. Call your doctor if a child in close contact with you develops swollen nipples or enlarged breasts.
Common side effects may include:
- nausea, vomiting, stomach cramps;
- bloating, swelling, weight gain;
- breast pain or tenderness;
- headache;
- vaginal itching or discharge, irregular vaginal bleeding or spotting;
- hair loss; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
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.
Pregnancy & Breastfeeding
Can I take Divigel (Transdermal) if I’m pregnant or breastfeeding?
Do not use estradiol topical if you are pregnant. Tell your doctor right away if you become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Divigel (Transdermal)?
Avoid getting this medicine in your eyes. If contact does occur, rinse with water.
Do not apply estradiol topical to your breast area.
Ask your doctor when to use sunscreen or other skin products on skin treated with estradiol topical.
Avoid smoking. It can greatly increase your risk of blood clots, dementia, stroke, or heart attack while using this medicine.
Grapefruit may interact with estradiol topical and cause side effects. Avoid consuming grapefruit products.
Dosage Guidelines & Tips
How to take Divigel (Transdermal)?
Use Divigel (Transdermal) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Estradiol topical is usually applied once per day. Follow your doctor's instructions.
Use the medicine at the same time each day.
Read and carefully follow any Instructions for Use provided on how to apply this medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Wash your hands with soap and water after applying the medicine. Do not allow other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.
Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine. Do not allow a child to come into contact with the skin where you have applied estradiol topical. If you cover with clothing, allow the medicine to dry well.
If you need surgery, or will be on bed rest, tell your healthcare provider ahead of time that you are using estradiol topical. You may need to stop using the medicine for a short time.
Estradiol may increase your risk of developing a condition that can lead to uterine cancer. To lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.
You may need frequent medical tests and your doctor will need to check your progress on a regular basis to determine how long you should use estradiol topical. You may need a pelvic exam, breast exam, and mammogram every year while using estradiol topical. Follow your doctor's instructions.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using estradiol topical.
Store at room temperature away from moisture and heat.
Estradiol topical may be flammable. Do not use near high heat or open flame. Do not smoke until the medicine has completely dried on your skin.
Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses in one day.