Estradiol Topical

Conditions Treated

Estradiol topical gel and emulsion (lotion type mixture) are used to treat and prevent 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). Estradiol topical gel is also used to treat vaginal dryness, itching, and burning in women who are experiencing menopause. However, women whose only bothersome symptoms are vaginal burning, itching, and dryness may benefit more from a medication that is applied topically to the vagina. Estradiol is in a class of medications called estrogen hormones. It works by replacing estrogen that is normally produced by the body.

Possible Side Effects

What Side Effects Can This Cause?

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

• headache
• breast pain or tenderness
• nausea
• diarrhea
• constipation
• gas
• heartburn
• weight gain or loss
• mood changes
• depression
• nervousness
• sleepiness
• difficulty falling asleep or staying asleep
• changes in sexual desire
• back pain
• runny nose
• cough
• flu-like symptoms
• hair loss
• unwanted hair growth
• darkening of the skin on the face
• difficulty wearing contact lenses
• irritation or redness of the skin where you applied topical estradiol
• swelling, redness, burning, irritation, or itching of the vagina
• vaginal discharge

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
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Topical estradiol may increase your risk of developing cancer of the ovaries and gallbladder disease that may need to be treated with surgery. Talk to your doctor about the risks of using this medication.Topical estradiol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Topical estradiol comes as a gel, a spray, and an emulsion to apply to the skin. It is usually applied once a day. Estradiol emulsion should be applied in the morning. Estradiol gel may be applied at any time of day, but should be applied at around the same time of day every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use topical estradiol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. If you are using estradiol gel, you should apply it in a thin layer to one arm, from the wrist to the shoulder. If you are using estradiol emulsion, you should apply it to both thighs and calves (lower legs). Do not apply estradiol gel or emulsion to your breasts. Be sure that the skin where you will apply topical estradiol is clean and completely dry, and is not red, irritated, or broken. If you take a bath or a shower or use a sauna, apply topical estradiol after you have finished bathing, showering or using the sauna and have dried your skin completely. If you plan to swim, allow as much time as possible between applying estradiol gel and swimming. Do not apply sunscreen shortly before, at the same time, or soon after you apply topical estradiol. Estradiol gel may catch fire. When you apply estradiol gel, do not smoke or go near a fire or open flame until the gel dries. Be careful not to get estradiol gel in your eyes. If you do get estradiol gel in your eyes, wash them with plenty of warm water right away. Call a doctor if your eyes become irritated. You should apply estradiol gel yourself. Do not let anyone else rub the gel onto your skin. To use estradiol gel, follow these steps:

Before you use your first dose of estradiol gel, remove the large cover of the pump and fully press down the pump twice. Wash the gel that comes out down the sink or throw it away in a trash can that is out of the reach of children and pets. This primes the pump so that it will dispense the same amount of medication each time it is pressed. Do not repeat this step after the first time you use the pump.

Hold the pump with one hand and cup your other hand below the nozzle of the pump. Press the pump firmly and fully to dispense one dose of gel onto your palm.

Use your hand to spread the gel as thinly as possible over your entire arm. Try to cover the inside and outside of your arm from your wrist to your shoulder with the gel.

Do not rub or massage the gel into your skin. Wait 5 minutes to allow the skin to dry before covering your arm with clothing.

Cover the pump with the small and large protective caps.

Wash your hands with soap and water.

To use estradiol emulsion, follow these steps:

Get two pouches of estradiol emulsion and sit in a comfortable position.

Open one pouch of estradiol emulsion by cutting or tearing across the notches near the top of the pouch.

Place the pouch flat on top of your left thigh with the open end facing your knee.

Hold the closed end of the pouch with one hand and use the forefinger of your other hand to push all of the emulsion in the pouch onto your thigh.

Use one or both hands to rub the emulsion into your entire thigh and calf for 3 minutes until completely absorbed.

Rub any emulsion that is left on your hands onto your buttocks.

Repeat steps 1-6 using a fresh pouch of estradiol emulsion and your right thigh so that you apply the contents of the second pouch to your right thigh and calf.

Wait until the skin where you applied estradiol emulsion is completely dry and cover it with clothing.

Wash your hands with soap and water.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What Dietary Instructions Should I Follow

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Are There Any Special Instructions

Before using topical estradiol, tell your doctor and pharmacist if you are allergic to estradiol gel or emulsion, any other estrogen products, any other medications, or any of the ingredients in estradiol gel or emulsion. Ask your pharmacist for a list of the ingredients in estradiol gel or emulsion or if you are not sure if a medication you are allergic to contains estrogen. 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);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); certain 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 asthma; seizures; migraine headaches; 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); yellowing of the skin or eyes, especially during pregnancy or while you were using an estrogen product; very high or very low levels of calcium in your blood; porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system) or gallbladder, thyroid, liver, pancreas, or kidney disease. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Remember to allow some time between applying topical estradiol and applying sunscreen. Estradiol gel may make your skin sensitive to sunlight. you should know that topical estradiol may harm other people who touch the medication that is on your skin or in the container. It is most harmful to men and children. Do not let anyone else touch the skin where you applied topical estradiol for one hour after you apply the medication. If someone does touch topical estradiol, that person should wash his or her skin with soap and water as soon as possible.