Elestrin

Elestrin is a prescription medication used to treat symptoms of menopause including hot flashes.

Elestrin contains estradiol which is a form of the hormone estrogen. It replaces estrogen that is not naturally produced by the ovaries.

This medication comes as a gel. It is usually applied once a day.

Common side effects of Elestrin include breast tenderness and irregular vaginal bleeding or spotting.

Elestrin is a prescription medication used to treat symptoms of menopause including hot flashes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Jazz Pharmaceuticals Commercial Corp.

• Meda Pharmaceuticals, Inc.

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.

Serious side effects have been reported with Elestrin including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not use Elestrin if you:

• are allergic to Elestrin or to any of its ingredients or have a known angioedema to Elestrin
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• currently have or have a history of blood clots
• have had a heart attack or stroke
• have been diagnosed with a bleeding disorder
• have liver disease
• are pregnant or possibly pregnant

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

Before taking Elestrin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Elestrin or to any of its ingredients or have a known angioedema to Elestrin
• have abnormal vaginal bleeding
• currently have or have had certain cancers
• currently have or have a history of blood clots
• have had a heart attack or stroke
• have been diagnosed with a bleeding disorder
• 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.
• if you are going to have surgery or will be on bed rest
• are pregnant or breastfeeding

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

Tell your doctor if you are pregnant or plan to become pregnant.

Elestrin should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Talk to your doctor right away if you become pregnant while using Elestrin.

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. 

Use Elestrin exactly as prescribed.

• This medication comes as a gel. It is usually applied to the once a day to the upper arm. 
• Elestrin comes in a metered-dose pump. One dose of Elestrin is released each time the pump is depressed (pressed down).
• 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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of Elestrin gel for the treatment of menopause symptoms is one pump ( 0.52 mg estradiol) or two pumps (1.04 mg estradiol) to the upper arm once daily. 

If you apply too much Elestrin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 20° to 25°C (68° to 77°F).
• Keep this and all medicines out of the reach of children.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Estrogen-Alone Therapy 

• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens

• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia

• The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)

• The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older 

Estrogen Plus Progestin Therapy 

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia 

• The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) 

• The WHI estrogen plus progestin study reported increased risks of invasive breast cancer 

• The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older