Menostar

Menostar is a prescription medication used to prevent osteoporosis in women after menopause. 

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

This medication is available as a transdermal patch. It is usually applied once a week. 

Common side effects of Menostar include upper respiratory tract infections, pain, and joint pain. 

Menostar is a prescription medication used to prevent osteoporosis in women after menopause. 

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

• Bayer Healthcare Pharmaceuticals Inc.

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

Common side effects of Menostar include the following:

• headache
• breast tenderness or pain
• irregular vaginal bleeding or spotting
• stomach or abdominal cramps, bloating
• nausea and vomiting
• hair loss
• fluid retention
• vaginal yeast infection
• redness or irritation at the patch placement site

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

Serious side effects have been reported with Menostar 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 Menostar if you:

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

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

Before using Menostar, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Menostar or to any of its ingredients
• have any unusual vaginal bleeding
• have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• are going to have surgery or will be on bed rest
• currently have or have had certain cancers
• had a stroke or heart attack
• currently have or have had blood clots
• 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.

Menostar 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 Menostar.

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

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

Use Menostar exactly as prescribed.

• Menostar is for skin use only.
• Change your Menostar patch 1 time each week or every 7 days.
• Apply your Menostar patch to a clean, dry area on your lower abdomen or buttocks. This area must be clean, dry, and free of powder, oil or lotion for your patch to stick to your skin.
• Apply your Menostar patch to a different area of your abdomen or your buttocks each time. Do not use the same application site 2 times in the same week.
• Do not apply Menostar to your breasts.
• If you forget to apply a new Menostar patch, apply a new patch as soon as possible.
• You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are using and whether you still need treatment with Menostar.

How to Change Menostar:

• When changing Menostar, peel off the used patch slowly from the skin.
• After removal of Menostar, people usually have either no adhesive residue or light adhesive residue. If any adhesive residue remains on your skin after removing the patch, allow the area to dry for 15 minutes. Then, gently rub the area with an oil-based cream or lotion to remove the adhesive from your skin.
• Keep in mind, the new patch must be applied to a different skin area of your abdomen or buttocks.This area must be clean, dry, and free of powder, oil or lotion. The same site should not be used again for at least 1 week after removal of the patch.

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 starting dose of Menostar (estradiol) transdermal patches for the prevention of osetoporosis in women after menopause is one (1) patch applied once a week. 

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

• Store Menostar at room temperature.
• 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 substudy 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