Divigel (estradiol) Gel 0.1%
- Divigel (estradiol gel) 0.1% is indicated for the treatment of moderate to severe hot flashes due to menopause.
Pharmacist - M.B.A. (Public Health) D.I.C.
Divigel (estradiol) Gel 0.1%
Generally, when estrogen is prescribed for a…
Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.
A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin.
Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause
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). 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. After application, the gel should be allowed to dry before dressing. The application site should not be washed within 1 hour after applying Divigel. Contact of the gel with eyes should be avoided. Hands should be washed after application.
Generally, women should be started at the 0.25 gram dosage strength.
You should not use Divigel if you have:
- abnormal vaginal bleeding that has not been checked by a doctor;
- any type of breast, uterine, or hormone-dependent cancer;
- 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;
- if you are pregnant or may become pregnant; or
- if you have ever had an allergic reaction to estradiol topical.
Estradiol will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estradiol may also increase your risk of uterine or ovarian cancer. Talk with your doctor about your individual risks.
To make sure Divigel is safe for you, tell your doctor if you have:
- unusual vaginal bleeding;
- heart disease;
- epilepsy or other seizure disorder;
- liver or kidney disease;
- hereditary angioedema;
- a thyroid disorder;
- high levels of calcium in your blood (hypercalcemia);
- gallbladder disease; or
- risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40, or if you have had a hysterectomy).
Do not use Divigel if you are pregnant. Use effective birth control to prevent pregnancy 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 prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
- Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using estradiol, to help lower this risk. Report any unusual vaginal bleeding right away.
- 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.
- Divigel contains alcohol. Alcohol based gels are flammable. Avoid fire, flame or smoking until the gel has dried.
- Wash your hands with soap and water after applying the gel or emulsion. Avoid allowing other people to get Divigel 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. 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 Divigel was applied. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.
Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estradiol.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.
Store Divigel at room temperature away from moisture and heat.
What happens if I miss a dose?
- Use the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not use extra medicine to make up the missed dose.
What should I avoid while using Divigel?
- Do not apply sunscreen to your skin at the same time you apply Divigel.
Avoid getting this medicine 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 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:
- abnormal vaginal bleeding;
- a lump in your breast;
- confusion, problems with memory or concentration;
- heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
- signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
- signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.
- Topical estradiol is absorbed through the skin of a child who comes into contact with this medicine. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.
Common Divigel side effects may include:
- breast pain;
- vaginal itching or discharge, changes in your menstrual periods, light vaginal bleeding or spotting;
- thinning scalp hair; or
- nausea, vomiting, bloating, stomach cramps.