"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Divigel Patient Information including How Should I Take
In this Article
- What is estradiol topical (Divigel)?
- What are the possible side effects of estradiol topical?
- What is the most important information I should know about estradiol topical?
- What should I discuss with my health care provider before using estradiol topical?
- How should I use estradiol topical?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using estradiol topical?
- What other drugs will affect estradiol topical?
- Where can I get more information?
What should I discuss with my health care provider before using estradiol topical?
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.
You should not use estradiol topical 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 estradiol topical, tell your doctor if you have any of these other conditions:
- high blood pressure, angina, or heart disease;
- high cholesterol or triglycerides;
- kidney disease;
- hereditary angioedema;
- epilepsy or other seizure disorder;
- a thyroid disorder;
- gallbladder disease; or
- low levels of calcium in your blood.
FDA pregnancy category X. This medication can cause birth defects. Do not use estradiol topical 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 this medication.
Estradiol can pass into breast milk and may harm a nursing baby. This medication 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 estradiol topical.
How should I use estradiol topical?
Use 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.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Apply estradiol topical only to clean, dry, unbroken skin. Do not apply to skin that is red or irritated. Never apply this medicine to the breasts.
To use the topical gel (such as Estrogel):
- Apply estradiol topical gel to the outside of your arm, from wrist to shoulder. Use the gel at the same time each day.
- Do not rub the gel in, but allow it to dry on your skin for at least 5 minutes before you dress.
- The gel form of this medicine is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
To use the topical emulsion (such as Estrasorb):
- Apply this medicine while you are sitting down. You will use two foil pouches each time you apply this medication, unless your doctor has told you otherwise.
- Cut or tear open the foil pouch and place the pouch on top of your left thigh, with the open end of the pouch pointing toward your knee.
- Hold the pouch with one hand and use the fingers of your other hand to gently push all of the medicine out of the pouch and onto your thigh.
- Spend at least 3 minutes rubbing the gel into your entire left thigh and calf. Rub any excess medicine onto your buttocks.
- Cut or tear open the second pouch and apply the medicine to your right leg using the same method described above.
To use the topical spray (such as Evamist):
- Apply the spray to the skin on the inside of your forearm, just below the elbow. Use the spray at the same time each day.
- Place the cone of the spray applicator directly to your skin and hold the pump upright. Press the pump fully one spray. If your doctor has prescribed more than one spray, choose a different place on your inside forearm for the second spray. Use only the number of sprays your doctor has recommended.
- Do not rub the spray in, but allow it to dry on your skin for at least 2 minutes before you dress. Do not wash your arm for at least 30 minutes after applying the spray.
Wash your hands with soap and water after applying the gel or emulsion. 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 estradiol topical. 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 estradiol topical.
Store at room temperature away from moisture and heat.
Additional Divigel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.