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Date:   8/15/2006 7:24:56 PM ( 18 y ago)

What is the most important information I should know about drospirenone and ethinyl 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 and ethinyl estradiol will not protect you from sexually transmitted diseases--including HIV or AIDS.
• Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels. Before using drospirenone and ethinyl estradiol, tell your doctor about all of your current and past medical conditions, and about all the medicines you use.
• Many other drugs can interact with drospirenone and ethinyl estradiol and make this medication less effective, increasing your risk of unintended pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals, herbal products, and drugs prescribed by other doctors.
• 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 is drospirenone and ethinyl estradiol?
• Drospirenone and ethinyl estradiol are female hormones involved in conception.
• Drospirenone and ethinyl estradiol are used to prevent pregnancy. This medication works by preventing ovulation (the release of an egg from an ovary).
• Drospirenone and ethinyl estradiol may also be used for purposes other than those listed in this medication guide.


What should I discuss with my healthcare provider before taking drospirenone and ethinyl estradiol
• Do not take drospirenone and ethinyl estradiol if you have:
· uncontrolled high blood pressure, or heart disease;
· a history of stroke or blood clot;
· liver disease or liver cancer;
· kidney disease;
· adrenal gland disorder;
· migraine headaches;
· diabetes with circulation problems;
· gallbladder disease;
· unusual vaginal bleeding;
· any type of breast, uterine, or hormone-dependent cancer;
· a history of jaundice (yellowing of the skin or eyes) during a pregnancy or while using birth control pills; or
· if you are 35 or older and you smoke 15 or more cigarettes per day.
• 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 ethinyl estradiol may affect breast milk. Do not take drospirenone and ethinyl estradiol without telling your doctor if you are breast-feeding a baby.
• Before using drospirenone and ethinyl estradiol, tell your doctor if you have:
· high cholesterol or triglycerides;
· congestive heart failure;
· a bleeding or blood clotting disorder; or
· depression.
• If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.
• Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels, including liver disease, kidney disease, and adrenal gland disorders. Before using drospirenone and ethinyl estradiol, tell your doctor if you have any of these conditions.
• 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).


How should I take drospirenone and ethinyl 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 the first pill in a package on the first day of your period or on the first Sunday after your period begins as directed by your doctor.
• Take one pill every day, no more than 24 hours apart. Try to take the pills at the same time each day to help you remember.
• Taking the pill at night may reduce noticeable side effects such as headache or nausea.
• If you are on a 28-day cycle, take one pill every day. When the pack runs out, throw it away. Begin a new pack the following day. The 28-day cycle contains seven pills that are placebos (with no active ingredients). These are "reminder" pills to keep you on a regular cycle. You will take them while you are on your period.
• You may need to use a backup method of birth control when you first start taking drosperinone and ethinyl estradiol or if you miss a pill. You may also need another form of birth control whenever you use certain other medicines. Some drugs can make birth control pills less effective and you could become pregnant. Follow your doctor's instructions for using a second form of birth control if you have any of these situations.
• See your doctor yearly for physical exams. Check your breasts for lumps monthly while you are taking drospirenone and ethinyl estradiol. Your doctor may also want to test the potassium levels in your blood. It is important that you not miss any scheduled appointments with your doctor.
• Drospirenone and ethinyl estradiol will not protect you from sexually transmitted diseases--including HIV or AIDS.
• Store drospirenone and ethinyl estradiol at room temperature away from moisture and heat.


What happens if I miss a dose?
• Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.
• If you miss one yellow "active" pill, take the dose as soon as you remember or take two pills at the time of your next regularly scheduled dose. You do not need to use backup birth control.
• If you miss two yellow "active" tablets in a row in week one or two, take two tablets each for the next two regularly scheduled doses (one missed tablet plus one regularly scheduled tablet for 2 days in a row). Use another form of birth control for at least 7 days following the missed tablets.
• If you miss two yellow "active" tablets in a row in week three, or if you miss three tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new package on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day. You may not have a period that month, but this is expected. However, if you miss your period 2 months in a row, call your doctor because you might be pregnant.
• If you miss one of the reminder pills in week four, skip that dose and take the next one as directed.
• If you miss a pill, you may become pregnant if you have sex in the 7 days after your missed pill. You MUST use another birth control method (such as condoms or spermicides) as a back-up for those 7 days.


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 ethinyl estradiol is not expected to produce life-threatening symptoms.


What should I avoid while taking drospirenone and ethinyl estradiol
• Avoid smoking cigarettes while taking drospirenone and ethinyl estradiol. Smoking greatly increases the risk of heart attack, stroke, and blood clot.


What are the possible side effects of drospirenone and ethinyl estradiol?
• 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 ethinyl estradiol and talk with your doctor if you have any of these less serious side effects:
· nausea and vomiting;
· breast tenderness or enlargement, enlargement of uterine fibroids;
· 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;
· vaginal yeast infections; or
· depression.
• 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 ethinyl estradiol?
• Before taking this medication, tell your doctor if you are using any of the following drugs:
· rifampin (Rifadin, Rimactane, Rifater);
· seizure medicine such as phenytoin (Dilantin), phenobarbital (Luminal), carbamazepine (Tegretol);
· an antibiotic such as ampicillin (Omnipen, Totacillin), tetracycline (Brodspec, Sumycin, Panmycin) or griseofulvin (Fulvicin);
· atorvastatin (Lipitor); or
· St. John's wort.
• If you are using any of these drugs, you may not be able to use dropirenone and estradiol.
• Many other drugs can interact with drospirenone and ethinyl estradiol and make this medication less effective, increasing your risk of unintended pregnancy. 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 ethinyl estradiol written for health professionals that you may read.

• 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: 3.02. Revision date: 5/ 17/ 06.




 

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