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DROSPIRENONE AND ETHINYL ESTRADIOL (Systemic)*†
Some commonly used brand names are:
In the U.S.—
Drospirenone and Ethinyl Estradiol(draw-SPEER-a-none and ETH-in-il es-tra-DYE-ole) This medicine is known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine usually contains two types of hormones, estrogens (ES-troh-jenz ) and progestins (proh-JES-tins) and, when taken properly, prevents pregnancy. It works by stopping a woman"s egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.
This medicine is available only with your doctor"s prescription, in the following dosage form:
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For drospirenone and ethinyl estradiol, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to estrogens or progestins. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy—Drospirenone and ethinyl estradiol is not recommended for use during pregnancy and should be discontinued if you become pregnant or think you are pregnant. Women who are not breast-feeding may begin to take oral contraceptives four weeks after having a baby.
Breast-feeding—Drospirenone and ethinyl estradiol pass into the breast milk and can change the content or lower the amount of breast milk. Also, they may shorten a woman"s ability to breast-feed. It may be necessary for you to use another method of birth control or to stop breast-feeding while taking drospirenone and ethinyl estradiol.
Children—This medicine is not designed for girls that have not reached menarche. This medicine is frequently used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.
Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking drospirenone and ethinyl estradiol, it is especially important that your doctor and pharmacist know if you are taking any of the following:
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other medical problems—The presence of other medical problems may affect the use of drospirenone and ethinyl estradiol. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine
Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.
To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.
A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of oral contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.
When you begin to use oral contraceptives , your body will require at least 7 days to adjust before a pregnancy will be prevented. You will need to use an additional birth control method for at least 7 days. Some doctors recommend using an additional method of birth control for the first cycle (or 3 weeks) to ensure full protection. Follow the advice of your doctor or other health care professional.
Try to take the doses no more than 24 hours apart to reduce the possibility of side effects and to prevent pregnancy . Since one of the most important factors in the proper use of oral contraceptives is taking every dose exactly on schedule, you should never let your tablet supply run out. When possible, try to keep an extra month"s supply of tablets on hand and replace it monthly.
It is very important that you keep the tablets in their original container and take the tablets in the same order that they appear in the container. The containers help you keep track of which tablets to take next. Different colored tablets in the same package contain different amounts of hormones or are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken out of order
Dosing— The dosing schedule is monophasic. You will be taking tablets of one strength (color) for 21 days. You will also take an additional 7 inactive tablets, which are another color. Taking the last 7 tablets is not required for full protection against pregnancy but they do help to replace estrogen.
Your health care professional may begin your dose on the first day of your menstrual period (called Day 1 start) or on Sunday after your period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even when you miss a dose. Do not change your schedule on your own. If the schedule that you have been put on is not convenient, check with your health care professional about changing schedules. For Sunday start you need to use another form of birth control for the first 7 days.
Missed dose—Follow your doctor"s orders or the directions on the label if you miss a dose of this medicine.
If you miss any of the last 7 (inactive) tablets, there is no danger of pregnancy. However, the first tablet (active) of the next month"s cycle must be taken on the regularly scheduled day, in spite of any missed doses, if pregnancy is to be avoided. The active and inactive tablets are colored differently for your convenience.
Storage—To store this medicine:
Precautions While Using This Medicine
It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:
Missed menstrual periods may occur:
Check with your doctor if you miss any menstrual periods so that the cause may be determined.
If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor .
If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Side Effects of This Medicine
Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.
Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives .
The following side effects may be caused by blood clots. Get emergency help immediately if any of the following side effects occur:
Abdominal or stomach pain (sudden, severe, or continuing); anxiety; burning pain in lower abdomen; changes in skin color; chill; coughing up blood; convulsions; fever; feeling of heat; feeling of warmth in lips and tongue; headache (severe or sudden); loss of coordination (sudden); loss of vision or change in vision (sudden); nervousness; numbness of the fingertips; pain in lower back, pelvis, or stomach; pains in chest, groin, or leg (especially in calf of leg); ringing in th ears; shortness of breath (sudden or unexplained); slurring of speech (sudden); sudden loss of consciousness; swelling of foot or leg; weakness, numbness, or pain in arm or leg (unexplained)
Check with your doctor as soon as possible if any of the following side effects occur:
More common—usually less common after the first 3 months of oral contraceptive use
Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes
Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse); increased blood pressure; vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
Mental depression; swelling, pain, or tenderness in upper abdominal area
For women who smoke tobacco
Pains in stomach, side, or abdomen; yellow eyes or skin
For women with a history of breast disease
Lumps in breast
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
Abdominal cramping or bloating; acne (usually less common after first 3 months and may improve if acne already exists); breast pain, tenderness, or swelling; dizziness; nausea; swelling of ankles and feet; unusual tiredness or weakness; vomiting
Brown, blotchy spots on exposed skin; gain or loss of body or facial hair; increased or decreased interest in sexual intercourse; weight gain or loss
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
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