Description
Estradiol topical emulsion is used to treat moderate to severe symptoms of menopause (eg, feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating [hot flashes]). Estradiol is an estrogen hormone. The hormone from the emulsion is absorbed through your skin into your body.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Gel/Jelly
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Use of estradiol topical emulsion is not indicated in the pediatric population. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of estradiol topical emulsion have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving estradiol topical emulsion.
Breastfeeding
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amifampridine
- Bupropion
- Ceritinib
- Conivaptan
- Donepezil
- Fosnetupitant
- Lixisenatide
- Netupitant
- Pixantrone
- Valproic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Ginseng
- Levothyroxine
- Licorice
- Tacrine
- Tipranavir
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Blood clots (eg, deep vein thrombosis, pulmonary embolism), active or history of or
- Breast cancer or history of or
- Dementia or
- Heart attack, active or history of or
- Heart or blood vessel disease or
- Liver disease or
- Protein C, protein S deficiency, or antithrombin deficiency, or other known blood clotting disorders or
- Stroke, active or history of or
- Surgery with a long period of inactivity or
- Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.
- Asthma or
- Cancer, history of or
- Diabetes or
- Edema (fluid retention or body swelling) or
- Endometriosis or
- Epilepsy (seizures) or
- Gallbladder disease or
- Hereditary angioedema (swelling of the face, lips, tongue, or throat) or
- Hypercalcemia (high calcium in the blood) or
- Hypertension (high blood pressure) or
- Hypertriglyceridemia (high triglycerides or fats in the blood) or
- Hypocalcemia (low calcium in the blood), severe or
- Hypothyroidism (an underactive thyroid) or
- Jaundice during pregnancy or from using hormonal therapy in the past or
- Kidney disease or
- Liver tumors or
- Migraine headache or
- Obesity or
- Porphyria (an enzyme problem) or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
Proper Use
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.
This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, breast, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
This medicine comes with a patient information insert and patients instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
To use:
- Wash your hands with soap and water before and after you use this medicine.
- Cut or tear the pouch when you are ready to apply the medicine on your skin. Open 1 pouch at a time.
- Apply this medicine to clean, dry skin on top of your left thigh by pushing the emulsion from the bottom up through the opening of the pouch.
- Rub the emulsion with 1 or 2 hands into the skin of your entire left thigh and lower back leg until it is completely rubbed into your skin. Repeat the same steps for the right leg. Allow the medicine to dry before you get dressed.
- Do not apply sunscreen at the same time you apply the emulsion.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For topical dosage form (emulsion):
- For hot flashes and other symptoms caused by menopause:
- Adults—Apply one pouch (1.74 grams) of the emulsion to the left thigh and calf and one pouch to the right thigh and calf each morning.
- Children—Use is not recommended.
- For hot flashes and other symptoms caused by menopause:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits may be every 3 to 6 months. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.
It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.
Using this medicine over a long period of time may increase your risk of breast cancer, endometrial cancer, or ovarian cancer. Do not use this medicine if you have had your uterus removed (hysterectomy). Check with your doctor immediately if you experience abnormal vaginal bleeding.
Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.
Using this medicine may increase your risk for gallbladder disease. Talk with your doctor about this risk.
Check with your doctor immediately if severe headache or sudden loss of vision, double vision, or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.
Do not take other medicines or drink grapefruit juice unless you discuss it with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Cough or hoarseness
- fever or chills
- lower back or side pain
- painful or difficult urination
Incidence not known
- Acid or sour stomach
- anxiety
- belching
- backache
- blistering, peeling, or loosening of the skin
- breast enlargement, pain, or tenderness
- change in vaginal discharge
- changes in skin color
- chest pain, discomfort, or tightness
- clay-colored stools
- clear or bloody discharge from nipple
- confusion
- constipation
- cramps
- dark urine
- decreased vision or other changes in vision
- diarrhea
- difficulty in speaking
- difficulty swallowing
- dimpling of the breast skin
- dizziness or lightheadedness
- double vision
- dry mouth
- dry skin and hair
- fainting
- fast heartbeat
- feeling cold
- full or bloated feeling or pressure in the stomach
- hair loss
- headache
- heartburn
- heavy bleeding
- hives, itching, skin rash
- husky voice
- inability to move the arms, legs, or facial muscles
- inability to speak
- incoherent speech
- increased urination
- indigestion
- inverted nipple
- irritability
- itching of the vagina or outside genitals
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- large amount of triglyceride in the blood
- light vaginal bleeding between regular menstrual periods
- loss of mental ability
- lump in breast or under the arm
- lumps in the breasts
- loss of appetite
- mental depression
- metallic taste
- mood or mental changes
- muscle cramps and stiffness
- nausea
- numbness and tingling around the mouth, fingertips, or feet
- pain
- pain, redness, or swelling in the arm or leg
- pain during sexual intercourse
- pain or feeling of pressure in pelvis
- painful or tender cysts in the breasts
- pains in the stomach, side, or abdomen, possibly radiating to the back
- persistent crusting or scaling of the nipple
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- redness or swelling of the breast
- seizures
- slow heartbeat
- slow speech
- sore on the skin of the breast that does not heal
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach discomfort, upset, or pain
- sweating
- swelling
- swelling of the stomach area
- thick, white curd-like vaginal discharge without odor or with mild odor
- trouble breathing
- unexpected or excess milk flow from the breasts
- unpleasant breath odor
- unusual tiredness or weakness
- vaginal bleeding
- vomiting
- vomiting of blood
- weight gain or loss
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Pain or tenderness around the eyes and cheekbones
- stuffy or runny nose
Incidence not known
- Brown, blotchy spots on the exposed skin
- decreased or increased interest in sexual intercourse
- inability to have or keep an erection
- increase or loss in sexual ability, desire, drive, or performance
- increased hair growth, especially on the face
- leg cramps
- patchy brown or dark brown discoloration of the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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