Elestrin

Generic name: Estradiol gel

What is Elestrin?

Elestrin is a colorless gel that contains an estrogen hormone called estradiol, which is absorbed through the skin into the bloodstream. Elestrin is used after menopause to reduce moderate-to-severe hot flashes.

What is the most important information I should know about Elestrin?

Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are using Elestrin. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots.

Do not use estrogens with or without progestins to prevent dementia. Using estrogens with or without progestins may increase your risk of dementia, based on a study of women age 65 years or older.

You and your healthcare provider should talk regularly about whether you still need treatment with Elestrin.

Do not use Elestrin to treat conditions for which it was not prescribed.

If you get Elestrin in your eyes, rinse your eyes right away with warm clean water to flush out any Elestrin. Seek medical attention if needed.

Do not give Elestrin to other people, even if they have the same symptoms you have.

Who should not take Elestrin?

Estrogen products, including Elestrin, should not be used in women who have or have had certain cancers, a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems. Do not take Elestrin if there is any chance you may be pregnant.

What should I tell my doctor before I take the first dose of Elestrin?

Tell your doctor about all prescription, over-the-counter, and herbal medication you are taking before beginning treatment with Elestrin. Also, talk to your doctor about your complete medical history, especially if you have certain conditions, such as asthma (wheezing), diabetes, gallbladder disease, depression, if you had your uterus removed (hysterectomy), epilepsy (seizures), migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, or kidneys, or you have high calcium levels in your blood.

Tell your doctor if you are going to have surgery or will be on bed rest. You may need to stop using Elestrin.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: Starting dose: 1 pump (0.87g) every day to upper arm. Apply Elestrin at the same time each day. Dosage adjustments will be made based on your response to treatment.

Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. Elestrin should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Elestrin.

How should I take Elestrin?

To activate the pump, unlock the pump by turning the spout on top of the bottle a quarter turn to the left or the right.

Before using the pump for the first time, prime the pump by fully depressing the spout ten (10) times. Throw away the unused gel by placing it in the trash to avoid another person or pet from accidental contact with the gel or, eating or drinking it.

After priming, the pump is ready to use. One complete pump will dispense the same amount of Elestrin each time. After each daily dose, return the spout to the locked position and replace the cap before you put it away.

Dry skin completely before applying Elestrin. You should apply your daily dose of gel to clean, dry, unbroken skin. If you take a bath or shower or use a sauna, apply Elestrin afterwards. If you go swimming, try to leave as much time as possible, at least 2 hours, between applying your Elestrin dose and going into the water.

To apply the dose, hold the pump with the tip facing the application area of the arm. For each pump depression needed, press the pump firmly and fully with a continuous motion without hesitation. Gently spread the gel using only 2 fingers. Spread and gently rub in the gel over the entire area of your upper arm and shoulder area. Allow the gel to dry for five minutes or more before dressing.

Never apply Elestrin to the breast or in or around the vagina.

Wash your hands with soap and water after applying the gel. Avoid fire, flame or smoking until the gel has dried. Elestrin contains alcohol. Alcohol-based gels are flammable.

Always move the spout into locked position and place the cap over the top of the pump after each use.

What should I avoid while taking Elestrin?

Do not apply sunscreen to the area where the gel was applied for at least 25 minutes. Do not apply sunscreen to the area where the gel was applied for 7 or more consecutive days.

Do not allow others to come in contact with the area of skin where you applied the gel for at least two hours after you apply Elestrin.

If you get Elestrin in your eyes, rinse your eyes right away with warm clean water to flush out any Elestrin. Seek medical attention if needed.

Grapefruit and grapefruit juice may interact with estradiol and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Avoid fire, flames or smoking until the gel has dried. Elestrin contains alcohol. Alcohol based gels are flammable.

Never apply Elestrin to the breast or in or around the vagina.

What are possible food and drug interactions associated with Elestrin?

If Elestrin is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Elestrin with the following: carbamazepine; clarithromycin; erythromycin; grapefruit juice; itraconazole; ketoconazole; phenobarbital; rifampin; ritonavir; and St. John 's Wort preparations (Hypericum perforatum).

What are the possible side effects of Elestrin?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: bloating, blood clots, breast cancer, breast pain, cancer of the uterus, dementia, enlargement of benign tumors of the uterus ("fibroids"), fluid retention, gallbladder disease, hair loss, headache, irregular vaginal bleeding or spotting, heart attack, high blood pressure, high blood sugar, liver problems, nausea and vomiting, ovarian cancer, stomach cramps, stroke, vaginal yeast infection

Some of the warning signs of serious side effects include: breast lumps, changes in speech, changes in vision, chest pain unusual vaginal bleeding, dizziness and faintness, leg pain, severe headaches, shortness of breath, vomiting.

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

These are not all the possible side effects of Elestrin. For more information, ask your healthcare provider or pharmacist.

Can I receive Elestrin if I am pregnant or breastfeeding?

Elestrin is intended for post-menopausal women. Tell your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Estrogen products should not be used during pregnancy. Avoid or use caution when using Elestrin in nursing females; this drug passes into breast milk.

What should I do if I miss a dose of Elestrin?

If you miss a dose, do not double the dose. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day.

How should I store Elestrin?

Store at room temperature, 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F).