Menostar

Generic Name: estradiol transdermal (ES tra DYE ole tranz DERM al)
Brand Names: Alora, Climara, Estraderm, Estradiol Patch, Menostar, Minivelle, Vivelle, Vivelle-Dot

What is Menostar?

Menostar is a skin patch that contains estradiol, a form of estrogen. Estradiol is a female sex hormone produced by the ovaries that regulates many processes in the body.

Menostar skin patches are used to prevent postmenopausal osteoporosis.

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

Important information

You should not use Menostar if you have: liver disease, a bleeding disorder, unusual vaginal bleeding, history of a hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer), or if you have ever had a heart attack, stroke, or a blood clot.

Slideshow: Flashback: FDA Drug Approvals 2013

Do not use Menostar if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

Menostar should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

Your doctor should check your progress on a regular basis to determine whether you should continue treatment with Menostar.

Before taking this medicine

You should not use Menostar if you are allergic to estradiol, if you are pregnant, or if you have:

  • unusual vaginal bleeding that a doctor has not checked;

  • liver disease;

  • a bleeding or blood-clotting disorder;

  • a recent history of heart attack or stroke;

  • a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

  • if you have ever had a blood clot (especially in your lung or your lower body).

Menostar should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure Menostar is safe for you, tell your doctor if you have:

  • heart disease;

  • risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);

  • a history of jaundice caused by pregnancy or birth control pills;

  • hereditary angioedema (an immune system disorder);

  • a thyroid disorder;

  • kidney disease;

  • asthma;

  • epilepsy or other seizure disorder;

  • migraines;

  • lupus;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • endometriosis or uterine fibroid tumors;

  • gallbladder disease;

  • high or low levels of calcium in your blood; or

  • if you have had your uterus removed (hysterectomy).

Long-term use of estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Menostar long term.

FDA pregnancy category X. Do not use Menostar if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using Menostar.

See also: Pregnancy and breastfeeding warnings (in more detail)

Estradiol can pass into breast milk. Menostar may slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use Menostar?

Use Menostar patches exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

Menostar comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Site Selection

The adhesive side of Menostar should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock.

  • Menostar should not be applied to or near the breasts.
  • The sites of application must be rotated, with an interval of at least 1-week allowed between applications to a same site.
  • The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the transdermal system off.
  • Application to areas where sitting would dislodge Menostar should also be avoided.

Application

  • Menostar should be applied immediately after opening the pouch and removing the protective liner.
  • Menostar should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges.
  • If the system lifts, apply pressure to maintain adhesion.
  • In the event that a system should fall off reapply it to a different location. If the system cannot be reapplied, a new system should be applied for the remainder of the 7-day dosing interval.
  • Only one system should be worn at any one time during the 7-day dosing interval.
  • Swimming, bathing, or using a sauna while using Menostar has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.

Removal of the Menostar Transdermal System

  • Removal of the system should be done carefully and slowly to avoid irritation of the skin.
  • Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue.
  • Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Menostar.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using Menostar.

Store Menostar patches at room temperature away from moisture and heat. Keep each patch in its pouch until you are ready to use it.

What happens if I miss a dose?

Apply a skin patch as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra patches to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Menostar?

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

Menostar side effects

Get emergency medical help if you have any of these signs of an allergic reaction to the Menostar patch: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • unusual vaginal bleeding;

  • swelling or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes);

  • a lump in your breast;

  • skin rash;

  • heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs;

  • low levels of calcium in your blood - numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or

  • high levels of calcium in your blood - nausea, vomiting, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Common Menostar side effects may include:

  • headache;

  • weight gain, bloating, stomach cramps, nausea, vomiting;

  • fluid retention (swelling, rapid weight gain);

  • thinning scalp hair;

  • redness or irritation where the patch was worn;

  • breast pain; or

  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Menostar?

Other drugs may interact with estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Menostar.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Menostar only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 15.01. Revision Date: 2014-10-09, 10:19:49 AM.

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