Generic Name: estradiol (ES-tra-DYE-ol)
Brand Name: Divigel
Divigel gel should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Divigel gel. Talk with your doctor if you have questions about the benefits and risks of using Divigel gel.
Divigel gel should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Divigel gel.
Divigel gel is used for:
Treating certain moderate to severe symptoms of menopause (eg, hot flashes).
Divigel gel is an estrogen hormone. It works by replacing estrogen in the body when it no longer produces enough on its own.
Do NOT use Divigel gel if:
- you are allergic to any ingredient in Divigel gel
- you have had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking Divigel gel
- you are pregnant or think you may be pregnant
- you have undiagnosed abnormal vaginal bleeding
- you have known or suspected breast cancer or another estrogen-dependent cancer, or you have a history of breast cancer
- you have liver problems or liver disease
- you have active blood clots (eg, of the legs or lungs), a history of blood clots, or a condition that may increase your risk of blood clots
- you have had a heart attack or stroke within the past 12 months
Contact your doctor or health care provider right away if any of these apply to you.
Before using Divigel gel:
Some medical conditions may interact with Divigel gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a condition called hereditary angioedema
- if you have a history of breast lumps, breast disease, or an abnormal mammogram, or if a member of your family has had breast cancer
- if you have a vaginal infection or a history of uterus problems (eg fibroids, endometriosis, abnormal vaginal bleeding, cancer), or you have had your uterus removed (hysterectomy)
- if you have a history of asthma, depression, memory problems, diabetes, seizures, gallbladder disease, pancreatitis, heart problems, heart attack, stroke, high blood cholesterol or triglyceride levels, high blood calcium levels, high blood pressure, low blood levels of parathyroid hormone, or porphyria
- if you have a history of kidney or liver problems, yellowing of the skin or eyes, cancer, lupus, migraines, thyroid problems, or chorea (jerky, involuntary movements of the face, arms, or legs)
- if you smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time
- if a member of your family has had high cholesterol or triglyceride levels, blood clots (eg, in the leg or lung), or lupus, or has been very overweight
Some MEDICINES MAY INTERACT with Divigel gel. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), or protease inhibitors (eg, ritonavir) because they may increase the risk of Divigel gel's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifamycins (eg, rifampin), or St. John's wort because they may decrease Divigel gel's effectiveness
- Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Divigel gel
This may not be a complete list of all interactions that may occur. Ask your health care provider if Divigel gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Divigel gel:
Use Divigel gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Divigel gel. Talk to your pharmacist if you have questions about this information.
- Apply Divigel gel to the upper thigh area of the right or left leg. Change between your left and right thigh each day to help avoid skin irritation.
- Apply Divigel gel to clean, intact skin only. Be sure the area is completely dry before applying Divigel gel.
- Do not apply Divigel gel to skin that is irritated or broken. Do not apply it to your face, in or around the vagina, or to your breasts.
- If you take a bath or shower, or use a sauna around the time of your dose, apply Divigel gel afterwards. Be sure the area is completely dry before applying the medicine.
- Open the packet and squeeze the entire contents of the packet onto the upper thigh of one leg. Gently spread the medicine as thinly as possible over an area of about 5 to 7 inches (about 2 palm prints). You do not need to rub the medicine in.
- Throw away the empty packet in the trash out of the reach of children and pets.
- Wash your hands with soap and water after using Divigel gel.
- Cover the application site with clothing after the medicine is completely dry. This will help to prevent others from coming into contact with the medicine. Be sure the medicine is completely dry before you dress.
- Do not wash the application site for at least 1 hour after you apply Divigel gel.
- Do not allow others to apply Divigel gel for you. Do not allow others to come into contact with the application site for at least 1 hour after you apply Divigel gel. If someone else comes into contact with Divigel gel, have them wash the area with soap and water right away.
- Use Divigel gel at the same time each day.
- If you spill some of Divigel gel while you are applying it, do not open a new packet. Wait and apply your regular dose the next day.
- If you miss a dose of Divigel gel, use it as soon as possible. If your next dose is less than 12 hours away, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Divigel gel.
Important safety information:
- Divigel gel may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
- Divigel gel is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse right away with warm clean water.
- Check with your doctor before applying sunscreen to the application site while using Divigel gel.
- If you will be swimming, wait until Divigel gel is completely dry before going into the water.
- Divigel gel is flammable. Do not store or use near heat or an open flame. Avoid fire, flame, or smoking until the medicine has dried on your skin.
- Eating grapefruit or drinking grapefruit juice may increase the risk of Divigel gel's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Divigel gel.
- Tell your doctor or dentist that you take Divigel gel before you receive any medical or dental care, emergency care, or surgery. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking Divigel gel or take other special precautions for a period of time.
- Divigel gel may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- Diabetes patients - Divigel gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Divigel gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Divigel gel.
- Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use Divigel gel. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Follow your doctor's instructions for examining your own breasts. Report any lumps immediately.
- Talk with your doctor regularly (eg, every 3 to 6 months) about whether you need to continue taking Divigel gel.
- Use Divigel gel with caution in the ELDERLY; they may be more sensitive to its effects.
- Divigel gel is not approved for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Divigel gel if you are pregnant. If you think you may be pregnant, contact your doctor right away. Divigel gel is found in breast milk. If you are or will be breast-feeding while you use Divigel gel, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Divigel gel:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast pain or tenderness; hair loss; headache; mild fluid retention; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf pain, swelling, or tenderness; chest pain; coughing up blood; fainting; mental or mood changes (eg, depression); migraine headache; new or worsening memory problems; pelvic pain; severe or persistent dizziness or headache; severe or persistent stomach or back pain (with or without nausea or vomiting); shortness of breath; swelling of the hands or feet; symptoms of heart attack (eg, chest, jaw, or arm pain; sudden severe nausea or vomiting; shortness of breath; sudden unusual sweating); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual vaginal discharge/itching/odor; vision loss or other vision changes; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal vaginal bleeding; breast tenderness; drowsiness or fatigue; nausea and vomiting; stomach pain.Proper storage of Divigel gel:
Store Divigel gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) with the cap secured. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Divigel gel out of the reach of children and away from pets.
- If you have any questions about Divigel gel, please talk with your doctor, pharmacist, or other health care provider.
- Divigel gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Divigel gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Divigel gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Divigel gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Divigel gel.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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