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drospirenone and estradiol

Generic Name: drospirenone and estradiol (droe SPYE re none and ES tra DYE ole)
Brand Name: 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.

The combination of drospirenone and estradiol is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medication is for use only if you have a uterus (if you have not had a hysterectomy).

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

Drospirenone and estradiol may also be used for purposes not listed in this medication guide.

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

Do not use drospirenone and estradiol if you are pregnant or plan to become pregnant.

You should not take this medicine if you have any of the following conditions: a bleeding or blood-clotting disorder, circulation problems, unusual vaginal bleeding, kidney disease, liver disease, an adrenal gland disorder, if you have had a hysterectomy, if you have had a heart attack a stroke, or if you have ever had breast or uterine cancer, or a blood clot (especially in your lung or your lower body).

Slideshow: Flashback: FDA Drug Approvals 2013

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of female hormone medication.

Stop using drospirenone and estradiol and call your doctor at once if you have chest pain, sudden numbness or weakness, a sudden severe headache, confusion, problems with vision or speech, or if you have pain, swelling, warmth, or redness in one or both legs.

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

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

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

You should not take this medicine if you are allergic to drospirenone or estradiol, or if you have:

  • a bleeding or blood-clotting disorder, or circulation problems;

  • unusual vaginal bleeding that has not been checked by a doctor;

  • kidney disease;

  • liver disease;

  • an adrenal gland disorder;

  • a history of hormone-related cancer such as breast or uterine cancer;

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

  • if you are pregnant or plan to become pregnant;

  • if you have had a heart attack or stroke; or

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

To make sure you can safely take drospirenone and estradiol, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure;

  • risk factors for coronary artery disease (such as smoking, being overweight, or a family history of coronary artery disease);

  • high cholesterol or triglycerides;

  • diabetes;

  • a thyroid disorder;

  • high levels of calcium, sodium, or potassium in your blood;

  • endometriosis;

  • gallbladder disease;

  • asthma;

  • severe migraines (with aura, numbness, weakness, or vision changes), especially if you are older than 35;

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

  • epilepsy or other seizure disorder;

  • hereditary angioedema (an immune system disorder);

  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;

  • systemic lupus erythematosus (SLE); or

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

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 risk, and report any unusual vaginal bleeding right away.

FDA pregnancy category X. Do not use drospirenone and estradiol if you are pregnant or plan to become pregnant. Tell your doctor right away if you become pregnant during treatment.

The hormones in drospirenone and estradiol can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

How should I take drospirenone and estradiol?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not crush, chew, or break a drospirenone and estradiol tablet. Swallow it whole.

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

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

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while taking drospirenone and estradiol.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you are less than 24 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is time for your next scheduled dose. Do not take extra medicine 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. Overdose symptoms may include severe nausea or vaginal bleeding.

What should I avoid while taking drospirenone and estradiol?

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of female hormone medication.

Avoid drinking alcohol while you are taking this medication.

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

Drospirenone and estradiol side effects

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

Stop using drospirenone and estradiol and call your doctor at once if you have a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

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

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

  • sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs;

  • confusion, unusual thoughts or behavior;

  • abnormal vaginal bleeding;

  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

  • severe pain in your upper stomach spreading to your back, vomiting;

  • itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • a breast lump.

Less serious side effects may include:

  • mild nausea or stomach pain, diarrhea;

  • mild headache;

  • irregular vaginal bleeding, spotting;

  • breast pain or tenderness;

  • weight gain, swelling in your hands or feet;

  • mood changes; or

  • vaginal itching or discharge.

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)

Drospirenone and estradiol dosing information

Usual Adult Dose for Postmenopausal Symptoms:

Treatment of moderate to severe vasomotor symptoms:

drospirenone 0.25 mg/estradiol 0.5 mg tablet or drospirenone 0.5 mg/estradiol 1 mg tablet, 1 tablet orally each day.

Treatment of moderate to severe symptoms of vulvar and vaginal atrophy:

drospirenone 0.5 mg/estradiol 1 mg tablet, 1 tablet orally each day.

What other drugs will affect drospirenone and estradiol?

Tell your doctor about all other medicines you use, especially:

  • eplerenone (Inspra);

  • heparin;

  • ritonavir (Norvir, Kaletra);

  • St. John's wort;

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or rifampin (Rifater, Rifadin, Rifamate);

  • an antifungal medication such as ketoconazole (Nizoral) or itraconazole (Sporanox);

  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

  • a blood thinner such as warfarin (Coumadin, Jantoven);

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

  • heart or blood pressure medications such as benazepril (Lotensin), candesartan (Atacand), enalapril (Vasotec), fosinopril (Monopril), irbesartan (Avapro, Avalide), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar), ramipril (Altace), valsartan (Diovan), telmisartan (Micardis);

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

  • seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Solfoton).

This list is not complete and other drugs may interact with drospirenone and estradiol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about drospirenone and estradiol.
  • 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.
  • 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 1996-2012 Cerner Multum, Inc. Version: 3.01. Revision Date: 2012-08-14, 10:45:31 PM.

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