Estradiol topical gel
What is Estradiol topical gel?
ESTRADIOL (EstroGel™) topical gel 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 gel is not yet available.
What should my health care professional know before I receive Estradiol?
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 this medicine be used?
Estradiol topical gel is for external use only. Follow the directions on the prescription label. Use exactly as directed. One-half applicatorful of estradiol topical gel contains enough medication for one day.
Apply Estradiol topical gel at the same time each day, preferably in the morning, to clean, dry, unbroken skin. If you take a bath or shower or use a sauna, apply your Estradiol topical gel after the bath, shower, or sauna. If you go swimming, try to leave as much as time as possible between applying your Estradiol topical gel dose and going swimming. The skin should be completely dry before applying the gel. Fill the applicator to halfway mark (1.25 mark) by squeezing tube. Apply all of the gel from the applicator to one arm and spread the gel as thinly as possible over the entire area on the inside and outside of your arm from wrist to shoulder. Replace the tube cap after use. Wash your hands with soap and water after applying the gel. Simply allow the gel to dry for up to 5 minutes before dressing. It is not necessary to rub or massage the gel into the skin. Avoid fire, flame or smoking until gel has dried. Do not apply to the breast.
- For all uses of this medicine:
Before starting this topical gel, 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 gel 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?
- 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 receiving Estradiol?
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?
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 gel 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 gel 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 gel, 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) with the cap on securely.. Throw away any unused medicine after the expiration date.
[ Last Revised: 9/15/2005 11:01:00 AM ]
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