Estradiol topical emulsion
What is estradiol topical emulsion?
ESTRADIOL (Estrasorb™) topical emulsion contains a natural estrogen female hormone. Estradiol is essential for maintaining normal female functions and is normally produced by the ovaries. After menopause, the ovaries decrease their production of this hormone. Estradiol can help relieve symptoms of the menopause (hot flashes, night sweats, mood changes, and vaginal dryness and irritation), and may also help to prevent the onset of osteoporosis (a loss of bone mass, so that bones become brittle and easily broken). Estrogens can also help improve female functions in women with hormonal imbalance or problems with their ovaries. Generic estradiol topical emulsion is not yet available.
What should my health care professional know before I use estradiol topical emulsion?
They need to know if you have any of these conditions:
- asthma
- blood vessel disease, blood clotting disorder, or suffered a stroke
- breast, cervical, endometrial or uterine cancer
- diabetes
- fibroids in the womb, or endometriosis
- heart, kidney or liver disease
- high blood lipids or cholesterol
- high blood pressure
- high level of calcium in the blood
- hysterectomy
- mental depression
- migraine
- porphyria
- systemic lupus erythematosus (SLE)
- tobacco smoker
- vaginal bleeding
- an unusual or allergic reaction to estrogens, other hormones, soy, other medicines, foods, dyes, or preservatives
- pregnant or trying to get pregnant
- breast-feeding
How should I use this medicine?
Estradiol topical emulsion is for external use only. Follow the directions on the prescription label. Use exactly as directed. Two packets of estradiol topical emulsion contain enough medication for one day.
Apply estradiol topical emulsion to clean dry skin on both legs in the morning. Apply the emulsion while you are in a comfortable sitting position. Open the foil pouches one at a time. Cut or tear the first foil pouch at the notches. Place the pouch flat on top of your left thigh, with the open end facing your knee. Hold the other end with one hand and use the forefinger of your other hand to push all of the contents of the pouch onto your left thigh. Use one hand or both hands to rub the emulsion into the entire left thigh and left calf for three minutes until it is completely absorbed. Rub any excess emulsion remaining on the hands onto the buttocks. Cut or tear the second foil pouch at the notches. Place the pouch flat on top of your right thigh, with the open end facing your knee. Hold the other end with one hand and use the forefinger of your other hand to push all of the contents of the pouch onto your right thigh. Use one hand or both hands to rub the emulsion into the entire right thigh and right calf for three minutes until it is completely absorbed. Rub any excess emulsion remaining on the hands onto the buttocks. Allow the emulsion to dry completely before covering with clothing. After you apply the emulsion to your legs wash both hands with soap and water to remove any residual emulsion.
- For all uses of this medicine:
Before starting this topical emulsion, read the paper on your prescription provided by your pharmacist or health care professional. This paper will tell you about the product you are using. Make certain you understand the instructions.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you forget to apply the topical emulsion in the morning, apply it as soon as possible. If it is almost time to apply the next dose, skip the missed dose and get back on your normal schedule. Do not use extra or double doses.
What drug(s) may interact with estradiol topical emulsion?
- some antibiotics used to treat infections
- some medications used to treat HIV (human immunodeficiency virus) infection or AIDS
- ascorbic acid/vitamin C supplements
- barbiturates or benzodiazepines used for inducing sleep or treating seizures (convulsions)
- bromocriptine
- carbamazepine
- cimetidine
- clofibrate
- cyclosporine
- dantrolene
- medications for diabetes
- griseofulvin
- hormones
- hydrocortisone, cortisone, or prednisolone
- imipramine or some other antidepressants
- isoniazid (INH)
- methotrexate
- mineral oil
- phenytoin
- raloxifene or tamoxifen
- rifabutin, rifampin, or rifapentine
- some medications for treating migraines
- sunscreens
- theophylline
- thyroid hormones
- topiramate
- tricyclic antidepressants
- warfarin
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What side effects may I notice from using estradiol topical emulsion?
Side effects that you should report to your prescriber or health care professional as soon as possible:
- breakthrough bleeding and spotting
- breast enlargement, tenderness, unusual discharge or milk production
- chest pain
- leg, arm or groin pain
- nausea, vomiting
- severe headaches
- stomach or abdominal pain (severe)
- sudden shortness of breath
- swelling of the hands, feet or ankles, or rapid weight gain
- vision or speech problems
- yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
- change in sexual desire
- irritation or mild redness at the application site
- increased or decreased appetite
- mild stomach upset
- mood changes, anxiety, depression, frustration, anger, or emotional outbursts
- skin rash, acne, or brown spots on the face
- tiredness
- vaginal yeast infection (irritation and white discharge)
- weight gain
What should I watch for while taking estradiol topical emulsion?
Visit your prescriber or health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam and ‘Pap’ smear. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests. If you have any unusual bleeding contact your prescriber or health care professional for advice.
Estradiol topical emulsion can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your prescriber or health care professional if you feel you are retaining fluid.
If you have any reason to think you are pregnant; stop using the topical emulsion at once and contact your prescriber or health care professional.
Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are using estradiol topical emulsion, especially if you are more than 35 years old. You are strongly advised not to smoke.
If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.
In women who still have their uterus, estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your doctor may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you.
If you are going to have elective surgery, you may need to stop taking your estrogens one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at room temperature between 15 - 30 degrees C (59 - 86 degrees F). Throw away any unused medicine after the expiration date.
[ Last Revised: 9/15/2005 11:01:00 AM ]
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