Elestrin

Elestrin is part of the drug class:

• Natural and semisynthetic estrogens, plain

Serious side effects have been reported with Elestrin . See the “Elestrin Precautions” section.

Common side effects of Elestrin include the following:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach or abdominal cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection

This is not a complete list of Elestrin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• 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)
• 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
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin 
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Elestrin drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Elestrin should not be used during lactation. Estrogen has been detected in human breast milk. Estrogen can decrease the quality or quantity of breast milk. Caution should be taken if Elestrin is given to a nursing mother. 

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Estradiol topical (for the skin) is used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

Estradiol topical may also be used for purposes not listed in this medication guide.

• Tell all of your health care providers that you take Elestrin. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
• This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Do not smoke. Smoking raises the chance of heart disease. Talk with your doctor.
• Limit your drinking of alcohol.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not use sunscreen before using gel or soon after using gel.
• Do not use sunscreen on gel part for 7 days in a row.
• If you are 65 or older, use Elestrin with care. You could have more side effects.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Elestrin, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Elestrin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Elestrin (estradiol gel (elestrin)).

Review Date: October 4, 2017

No drug interaction studies have been conducted for Elestrin.

Metabolic Interactions

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John’s wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice, may increase plasma concentrations of estrogens and result in side effects.

See FDA-Approved Patient Labeling.

Vaginal Bleeding

Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider as soon as possible [see Warning and Precautions (5.2)].

Possible Serious Adverse Reactions with Estrogen-Alone Therapy

Inform postmenopausal women of possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.1, 5.2, 5.3)].

Possible Less Serious but Common Adverse Reactions with Estrogen-Alone Therapy

Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea and vomiting.

Elestrin®
(estradiol gel)

Read this PATIENT INFORMATION before you start using Elestrin and read what you get each time you refill your Elestrin prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

What is the most important information I should know about Elestrin (an estrogen hormone)?

• Using estrogen-alone may increase your chance of getting cancer of the uterus (womb) 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 (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function) • Using estrogen-alone may increase your chances of getting strokes or blood clots • Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years or older • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots • Using estrogens with progestins may increase your chance of getting 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

What is Elestrin?

Elestrin is a medicine in a colorless gel that contains an estrogen hormone (estradiol) which is absorbed through the skin into the bloodstream.

What is Elestrin used for?

Elestrin is used after menopause to:

• Reduce moderate to severe hot flashes

Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”

When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Elestrin.

Who should not use Elestrin?

Do not start using Elestrin if you:

• Have unusual vaginal bleeding • Currently have or have had certain cancers   Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Elestrin. • Had a stroke or heart attack • Currently have or have had blood clots • Currently have or have had liver problems • Have been diagnosed with a bleeding disorder • Are allergic to Elestrin or any of its ingredients   See the list of ingredients in Elestrin at the end of this leaflet • Think you may be pregnant   Tell your healthcare provider: • If you have any unusual vaginal bleeding   Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. • About all of your medical problems   Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. • About all the medicines you take   This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Elestrin works. Elestrin may also affect how your other medicines work. • If you are going to have surgery or will be on bed rest   You may need to stop using Elestrin. • If you are breastfeeding   The hormone in Elestrin can pass into your breast milk.

How should I use Elestrin?

1. Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. 2. 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.

Elestrin comes in a metered-dose pump. One dose of Elestrin is released each time the pump is depressed (pressed down).

Use Elestrin exactly how your healthcare provider tells you.

The Elestrin pump contains enough of the medicine to let you prime the pump (get the pump ready) before you use it the first time. To prime the pump, push the head of the pump down slowly, then remove your finger from the pump head and allow it to spring back automatically (by itself). Repeat this until the gel comes out. Throw away this first amount of gel as it will not be a full dose. Once the pump head has come all the way back up, the pump is now primed and ready to use. With each dose, remember to push the pump head down slowly and allow it to spring back automatically. Let the pump head come all the way back up before you push it down again. If using more than 1 dose, wait 5 seconds before pumping the next dose. This will make sure that the pump works correctly and gives your full dose of Elestrin. Use the pump a total of 30 times (30 pushes) as your healthcare provider tells you. After you have initially primed the pump and have used a total of 30 doses of Elestrin, you will need to throw the pump away and use a new one. The correct amount of medicine in each dose cannot be assured after 30 doses have been used, even though the pump container is not completely empty.

Important things to remember when using Elestrin

Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people.

Allow the gel to dry for five minutes or more before dressing. Try to keep the area dry for as long as possible. 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.

Always move the spout into locked position and place the cap over the top of the pump after each use. Never apply Elestrin to the breast. Never apply Elestrin in or around the vagina.

Do not allow others to apply the gel for you.

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.

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

It is important that you read and follow the detailed “Patient Instructions for Use” at the end of this leaflet on how to use the Elestrin pump and apply the dose.

What should I do if someone else is exposed to Elestrin?

If someone else is exposed to Elestrin by direct contact with the gel, that person should wash the area of contact with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some of the estrogen hormone. This is especially important for men and children.

What should I do if I get Elestrin in my eyes?

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.

What should I do if I miss a dose?

If you miss a dose, do not double the dose on the next day to catch up. 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.

What are the possible side effects of Elestrin?

Side effects are grouped by how serious they are and how often they happen when you are treated. Serious, but less common side effects include:

• Heart attack • Stroke • Blood clots • Dementia • Breast cancer • Cancer of the lining of the uterus (womb) • Cancer of the ovary • High blood pressure • High blood sugar • Gallbladder disease • Liver problems • Enlargement of benign tumors of the uterus (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

• New breast lumps • Unusual vaginal bleeding • Changes in vision or speech • Sudden new severe headaches • Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Less serious, but common side effects include:

• Headache • Breast pain • Irregular vaginal bleeding or spotting • Stomach or abdominal cramps, bloating • Nausea and vomiting • Hair loss • Fluid retention • Vaginal yeast infection

These are not all the possible side effects of Elestrin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to Meda Pharmaceuticals Inc. at 1-877-999-8401 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with Elestrin?

• Talk with your healthcare provider regularly about whether you should continue using Elestrin • If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.

The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right away if you get vaginal bleeding while using Elestrin.

• Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else

If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.

• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance for getting heart disease

Ask your healthcare provider for ways to lower your chances of getting heart disease.

General information about safe and effective use of Elestrin

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Elestrin for conditions for which it was not prescribed. Do not give Elestrin to other people, even if they have the same symptoms you have. It may harm them.

Keep Elestrin out of the reach of children

This leaflet provides a summary of the most important information about Elestrin. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Elestrin that is written for health professionals. You can get more information by calling 1-877-999-8401 (toll free).

Patient Instructions for Use.

1. Remove the cap.

2. Activate the pump.

• Unlock the pump by turning the spout on top of the bottle a quarter turn to the left or the right.

3. Prime the pump (get the pump ready) before using the pump for the first time.

• Push the head of the pump down slowly and allow it to spring back automatically. Repeat this until gel comes out. Throw away the first amount of gel as it will not be a full dose. Once the pump head has come all the way back up, the pump is now primed and ready to use. 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 depression 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.

4. Apply Elestrin.

• 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 after your bath, shower, or sauna. 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. • Apply Elestrin at the same time each day.

Figure 1

  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.     Figure 2   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, as illustrated.  

5. Wash your hands with soap and water.

Elestrin should not be used after the date printed on the container (expiration date).
What are the ingredients in Elestrin?

Active ingredient: estradiol.

Inactive ingredients: purified water, ethanol, propylene glycol, diethylene glycol monoethyl ether, carbomer 940, triethanolamine, and edetate disodium.

MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks and Elestrin is a registered trademark of Meda AB or a related entity.

Distributed by:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

©2017 Meda Pharmaceuticals Inc.

U.S. Pat. No. 7,198,801 and U.S. Pat. No. 7,470,433

Rev. 8/2017
IN-0480-03
140893