Divigel Gel PacketsGeneric Name: Estradiol
Divigel Gel Packets 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 Packets. Talk with your doctor if you have questions about the benefits and risks of using Divigel Gel Packets.
Divigel Gel Packets 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 Packets.
Divigel Gel Packets are used for:
Treating certain moderate to severe symptoms of menopause (eg, hot flashes).
Divigel Gel Packets are 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 Packets if:
- you are allergic to any ingredient in Divigel Gel Packets
- you are pregnant or suspect you may be pregnant
- you have undiagnosed abnormal vaginal bleeding
- you have a history of blood clots (eg, in the lungs, legs, eyes); endometrial, cervical, or vaginal cancer; estrogen-dependent growths; breast cancer; or liver problems
- 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 Packets:
Some medical conditions may interact with Divigel Gel Packets. 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 history of endometriosis, growths in the uterus, abnormal mammogram, abnormal vaginal bleeding, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
- if you have dementia or other memory problems, or abnormal blood calcium levels
- if you have a history of asthma, cancer, high blood cholesterol or lipid levels, diabetes, heart problems, high blood pressure, heart attack or stroke, kidney problems, liver tumor, mental or mood problems (eg, depression), underactive thyroid, migraine headaches, gallbladder or pancreas problems, seizures (eg, epilepsy), lupus, chorea, or the blood disease porphyria
- if you smoke, are very overweight, or will be having surgery
- if you have a history of yellowing of the eyes or skin during pregnancy or with past estrogen use
- if a member of your family has a history of blood clots (eg, in the legs, lungs, eyes), diabetes, lupus, or obesity
- if you have had your uterus removed (hysterectomy)
Some MEDICINES MAY INTERACT with Divigel Gel Packets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Divigel Gel Packets's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Divigel Gel Packets's effectiveness
- Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Divigel Gel Packets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Divigel Gel Packets 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 Packets:
Use Divigel Gel Packets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Divigel Gel Packets. Talk to your pharmacist if you have questions about this information.
- Apply Divigel Gel Packets 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 Packets to clean, intact skin only. Be sure the area is completely dry before applying Divigel Gel Packets.
- Do not apply Divigel Gel Packets 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 Packets 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 Packets.
- 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 Packets.
- Do not allow others to apply Divigel Gel Packets for you. Do not allow others to come into contact with the application site for at least 1 hour after you apply Divigel Gel Packets. If someone else comes into contact with Divigel Gel Packets, have them wash the area with soap and water right away.
- Use Divigel Gel Packets at the same time each day.
- If you spill some of Divigel Gel Packets 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 Packets, 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 Packets.
Important safety information:
- Divigel Gel Packets are 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 Packets.
- If you will be swimming, wait until Divigel Gel Packets are completely dry before going into the water.
- Divigel Gel Packets are flammable. 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 Packets's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Divigel Gel Packets.
- Tell your doctor or dentist that you take Divigel Gel Packets before you receive any medical or dental care, emergency care, or surgery. If possible, Divigel Gel Packets should be stopped at least 4 to 6 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (such as a long plane flight, car ride, bedrest, or illness).
- Divigel Gel Packets 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 Packets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Divigel Gel Packets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Divigel Gel Packets.
- Lab tests and medical exams, including breast exams, mammograms, Pap tests, physicals, and blood pressure, may be performed while you use Divigel Gel Packets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Examine your breasts monthly as directed by your doctor. Report any lumps right away.
- Divigel Gel Packets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Divigel Gel Packets if you are pregnant. If you think you may be pregnant, contact your doctor right away. Divigel Gel Packets are found in breast milk. If you are or will be breast-feeding while you use Divigel Gel Packets, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Divigel Gel Packets:
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:
Breast pain or tenderness; headache; mild hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred or double vision, vision loss, or other vision changes; breast lump or discharge; calf or leg pain or swelling; chest pain; confusion; coughing up blood; fainting; memory problems; mental or mood changes (eg, depression); migraine headache; numbness of an arm or leg; one-sided weakness; persistent or recurring abnormal vaginal bleeding; severe or persistent headache or dizziness; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; slurred speech; swelling of the hands, legs, or feet; vaginal discharge, itching, or odor; yellowing of the skin or eyes.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include abnormal vaginal bleeding; or severe or persistent nausea or vomiting.Proper storage of Divigel Gel Packets:
Store Divigel Gel Packets 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 Packets out of the reach of children and away from pets.
- If you have any questions about Divigel Gel Packets, please talk with your doctor, pharmacist, or other health care provider.
- Divigel Gel Packets are 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.
This information is a summary only. It does not contain all information about Divigel Gel Packets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.