DrugindexOnline^{2nd edition}

Generic Name: drospirenone and estradiol (dro SPY re nown, ESS tra dy ol)
Brand Names: Angeliq

What is drospirenone and estradiol?

Drospirenone is a female hormone that helps regulate ovulation and menstruation.

Estradiol is a female hormone involved in development and maintenance of the female reproductive system.

Drospirenone and estradiol is used to treat the symptoms of menopause such as hot flashes or vaginal changes (itching, burning, dryness, urination problems). It is also used to prevent thinning of the bones (osteoporosis).

Drospirenone and estradiol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about drospirenone and estradiol?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels. Before using drospirenone and estradiol, tell your doctor about all of your current and past medical conditions, and about all the medicines you use. Stop using this medication and call your doctor at once if you feel short of breath, have sudden numbness or weakness on one side of the body, sudden headache, confusion, or problems with vision, speech, or balance.

Call your doctor right away if you have a breast lump, unusual vaginal bleeding, or jaundice (yellowing of the skin or eyes).

What should I discuss with my doctor before taking drospirenone and estradiol?

Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels. Before using drospirenone and estradiol, tell your doctor if you have any of the following:

• a history of liver disease;
• a history of jaundice (yellowing of the skin or eyes) during a pregnancy or while using birth control pills;
• kidney disease;

• adrenal insufficiency;

• hemophilia or other bleeding disorder;

• a history of stroke or blood clot;

• unusual vaginal bleeding; or

• any type of breast, uterine, or hormone-dependent cancer.

Certain medicines can also affect potassium levels. Tell your doctor if you use any of the following drugs:

• heparin;

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), ibuprofen (Motrin, Advil), indomethacin, naproxen (Aleve, Naprosyn), piroxicam (Feldene);

• a diuretic ("water pill") such as spironolactone (Aldactone), triamterene (Dyrenium, Dyazide, Maxzide), amiloride (Midamor), or eplerenone (Inspra);

• a potassium supplement such as Klor-Con, K-Dur, K-Tab;

• an ACE inhibitor such as benazepril (Lotensin), lisinopril (Prinivil, Zestril), enalapril (Vasotec); or

• blood pressure medicine such as candesartan (Atacand), losartan (Cozaar), telmisartan (Micardis).

If you have any of the following conditions, you may not be able to use drospirenone and estradiol, or you may need a dosage adjustment or special tests during treatment:

• high blood pressure, angina, heart disease, high cholesterol or triglycerides;

• liver or kidney disease;

• asthma;

• epilepsy;

• migraines, depression;

• diabetes;

• gallbladder disease;

• uterine fibroids; or

• you have had a hysterectomy (uterus removed).

FDA pregnancy category X. This medication can cause birth defects. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Drospirenone and estradiol may affect breast milk. Do not take drospirenone and estradiol without telling your doctor if you are breast-feeding a baby.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Taking the combination of drospirenone and estradiol may reduce this risk. Talk with your doctor about your individual situation, and report any unusual vaginal bleeding right away.

How should I take drospirenone and estradiol?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor.

Take each dose with a full glass of water.

Try to take drospirenone and estradiol at the same time each day.

Store drospirenone and estradiol at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of drospirenone and estradiol is not expected to produce life-threatening symptoms.

What should I avoid while taking drospirenone and estradiol

There are no restrictions on food, beverages, or activity while taking drospirenone and estradiol unless your doctor directs otherwise.

Drospirenone and estradiol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• chest pain;

• shortness of breath;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• unusual vaginal bleeding;

• stomach pain, swelling, or tenderness;

• jaundice (yellowing of the skin or eyes); or

• breast lump.

Continue using drospirenone and estradiol and talk with your doctor if you have any of these less serious side effects:

• nausea and vomiting;

• breast tenderness or enlargement;

• swelling of your hands or feet;

• darkened skin, especially on your face;

• changes in your menstrual periods;

• headache, migraine, dizziness, or fainting;

• problems with contact lenses;

• depression;

• vaginal yeast infections; or

• enlargement of uterine fibroids.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect drospirenone and estradiol?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• insulin or diabetes medicine taken by mouth, including glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), chlorpropamide (Diabinese), tolazamide (Tolinase), tolbutamide (Orinase), and others; or

• a blood thinner such as warfarin (Coumadin).

If you are using any of these drugs, you may not be able to use dropirenone and estradiol.

There may be other drugs not listed that can affect drospirenone and estradiol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has additional information about drospirenone and estradiol written for health professionals that you may read.

What does my medication look like?

Drospirenone and estradiol is available with a prescription under the brand name Angeliq. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Angeliq 0.5 mg/1 mg - round, biconvex pink film-coated tablets.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• 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 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 4/7/06 12:42:17 PM.