Divigel (Estradiol)

(ess' troe jen)

Estrogen increases the risk that you will develop endometrial cancer (cancer of the lining of the uterus [womb]). The longer you take estrogen, the greater the risk that you will develop endometrial cancer. If you have not had a hysterectomy (surgery to remove the uterus), you should be given another medication called a progestin to take with estrogen. This may decrease your risk of developing endometrial cancer, but may increase your risk of developing certain other health problems, including breast cancer. Before you begin taking estrogen, tell your doctor if you have or have ever had cancer and if you have unusual vaginal bleeding. Call your doctor immediately if you have abnormal or unusual vaginal bleeding during your treatment with estrogen. Your doctor will watch you closely to help ensure you do not develop endometrial cancer during or after your treatment. In a large study, women who took estrogen with progestins had a higher risk of heart attacks, strokes, blood clots in the lungs or legs, breast cancer, and dementia (loss of ability to think, learn, and understand). Women who take estrogen alone may also have a higher risk of developing these conditions. Tell your doctor if you smoke or use tobacco, if you have had a heart attack or a stroke in the past year, and if you or anyone in your family has or has ever had blood clots or breast cancer. Also tell your doctor if you have or have ever had high blood pressure, high blood levels of cholesterol or fats, diabetes, heart disease, lupus (a condition in which the body attacks its own tissues causing damage and swelling), breast lumps, or an abnormal mammogram (x-ray of the breast used to find breast cancer). The following symptoms can be signs of the serious health conditions listed above. Call your doctor immediately if you experience any of the following symptoms while you are taking estrogen: sudden, severe headache; sudden, severe vomiting; speech problems; dizziness or faintness; sudden complete or partial loss of vision;double vision; weakness or numbness of an arm or a leg; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; difficulty thinking clearly, remembering, or learning new things; breast lumps or other breast changes; discharge from nipples; or pain, tenderness, or redness in one leg. You can take steps to decrease the risk that you will develop a serious health problem while you are taking estrogen. Do not take estrogen alone or with a progestin to prevent heart disease, heart attacks, strokes, or dementia. Take the lowest dose of estrogen that controls your symptoms and only take estrogen as long as needed. Talk to your doctor every 3 to 6 months to decide if you should take a lower dose of estrogen or should stop taking the medication. You should examine your breasts every month and have a mammogram and a breast exam performed by a doctor every year to help detect breast cancer as early as possible. Your doctor will tell you how to properly examine your breasts and whether you should have these exams more often than once a year because of your personal or family medical history. Tell your doctor if you are having surgery or will be on bed rest. Your doctor may tell you to stop taking estrogen 4 to 6 weeks before the surgery or bed rest to decrease the risk that you will develop blood clots. Talk to your doctor regularly about the risks and benefits of taking estrogen.

Estrogen is used to treat hot flushes ('hot flashes'; sudden strong feelings of heat and sweating) in women who are experiencing menopause ('change of life', the end of monthly menstrual periods). Some brands of estrogen are also used to treat vaginal dryness, itching, or burning, or to prevent osteoporosis (a condition in which the bones become thin and weak and break easily) in women who are experiencing or have experienced menopause. However, women who need a medication only to treat vaginal dryness or only to prevent osteoporosis should consider a different treatment. Some brands of estrogen are also to relieve symptoms of low estrogen in young women who do not produce enough estrogen naturally. Some brands of estrogen are also used to relieve the symptoms of certain types of breast and prostate (a male reproductive gland) cancer. Estrogen is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.

Estrogen comes as a tablet to take by mouth. It is usually taken with or without food once a day. Estrogen is sometimes taken every day and sometimes taken according to a rotating schedule that alternates a period of time when estrogen is taken every day with a period of time when estrogen is not taken. When estrogen is used to relieve the symptoms of cancer, it is usually taken three times a day. Take estrogen at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take estrogen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor may start you on a low dose of estrogen and gradually increase your dose if your symptoms are still bothersome, or decrease your dose if your symptoms are well-controlled. Talk to your doctor about how well estrogen works for you. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking estrogen,
• tell your doctor and pharmacist if you are allergic to any brand of oral estrogen, any other estrogen products, any other medications, or any of the ingredients in estrogen tablets. If you will be taking Estrace® brand tablets, tell your doctor and pharmacist if you are allergic to aspirin or tartrazine (a food color additive). Ask your pharmacist or check the manufacturer's patient information for a list of the inactive ingredients in the brand of estrogen tablets you plan to take.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); aprepitant (Emend); carbamazepine (Carbatrol, Epitol, Tegretol); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); dexamethasone (Decadron, Dexpak); diltiazem (Cardizem, Dilacor, Tiazac, others); erythromycin (E.E.S, Erythrocin);fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); griseofulvin (Fulvicin, Grifulvin, Gris-PEG); lovastatin (Altocor, Mevacor); medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); medications for thyroid disease; nefazodone; phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); sertraline (Zoloft); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had yellowing of the skin or eyes during pregnancy or during your treatment with an estrogen product, endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body), uterine fibroids (growths in the uterus that are not cancer), asthma, migraine headaches, seizures, porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system), very high or very low levels of calcium in your blood, or thyroid, liver, kidney, gallbladder, or pancreatic disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking estrogen, call your doctor immediately.
• talk to your doctor about the risks and benefits of taking estrogen if you are 65 years of age or older. Older women should not usually take oral estrogen unless they are also taking other hormones. Oral estrogen taken without other hormones is not as safe or effective as other medications that can be used to treat the same condition.
• if you are taking estrogen to prevent osteoporosis, talk to your doctor about other ways to prevent the disease such as exercising and taking vitamin D and/or calcium supplements.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine. Talk to your doctor about ways to increase the amount of calcium and vitamin D in your diet, especially if you are taking estrogen to prevent osteoporosis.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Estrogen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• breast pain or tenderness
• upset stomach
• vomiting
• heartburn
• constipation
• diarrhea
• gas
• weight gain or loss
• leg cramps
• nervousness
• depression
• dizziness
• burning or tingling in the arms or legs
• tight muscles
• hair loss
• unwanted hair growth
• spotty darkening of the skin on the face
• difficulty wearing contact lenses
• swelling, redness, burning, itching, or irritation of the vagina
• vaginal discharge
• change in sexual desire
• cold symptoms

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• bulging eyes
• sore throat, fever, chills, cough, and other signs of infection
• pain, swelling, or tenderness in the stomach
• loss of appetite
• weakness
• yellowing of the skin or eyes
• joint pain
• movements that are difficult to control
• rash or blisters
• hives
• itching
• swelling of the eyes, face, tongue, throat, hands, arms, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Estrogen may increase your risk of developing cancer of the ovaries or gallbladder disease that may need to be treated with surgery. Talk to your doctor about the risks of taking estrogen. Estrogen may cause growth to slow or stop early in children who take large doses for a long time. Estrogen may also affect the timing and speed of sexual development in children. Your child's doctor will monitor him or her carefully during his or her treatment with estrogen. Talk to your child's doctor about the risks of giving this medication to your child. Estrogen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking estrogen. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. ¶ This branded product is no longer on the market. Generic alternatives may be available.