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Norelgestromin and Ethinyl Estradiol (Systemic)
In the U.S.-
Norelgestromin/Ethinyl Estradiol (nor-el-JES-tro-min/ ETH-in-il es-tra-DYE-ole ) contraceptive skin patch is used to prevent pregnancy. Hormones from the patch are absorbed through your skin into your body. 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.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. Discuss with your health care professional your options for birth control.
Norelgestromin/Ethinyl Estradiol does not prevent AIDS or other sexually transmitted diseases. It will not prevent, hepatitis B. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is available only with your doctor's prescription, in the following dosage forms:
Before Using This Medicine
In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. If you are using the skin patch contraceptive for contraception you should understand how their benefits and risks compare to those of other birth control methods. This is a decision you, your sexual partner, and your doctor will make. For norelgestromin/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. Tell your doctor if you have ever had any unusual or reaction to any other hormones. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy- Norelgestromin/ethinyl estradiol is not recommended during pregnancy and should be discontinued if you become pregnant or think you are pregnant. In rare cases when hormonal contraceptives have been taken by mistake early in pregnancy, problems to the fetus have not occurred. Be sure you have discussed this with your doctor.
Breast-feeding- It is not known whether norelgestromin/ethinyl estradiol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.
Children- Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of norelgestromin/ethinyl estradiol in children with use in other age groups. This medicine should not be used before the start of menstruation.Teenagers- This medicine may be 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 norelgestromin/ethinyl estradiol exactly as prescribed.
Older adults- Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of norelgestromin/ethinyl estradiol in the elderly with use in other age groups.
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 norelgestromin/ethinyl estradiol, it is especially important that your doctor and pharmacist know if you are taking any of the following:
Other medical problems- The presence of other medical problems may affect the use of norelgestromin/ethinyl estradiol. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine
To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use 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 hormonal contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.
When you begin using norelgestromin and ethinyl estradiol, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle.
Keep each patch in the package until you are ready to use it. Apply the patch to clean, dry skin on the abdomen, upper body, the upper outside part of the arm, or the buttocks. Avoid touching the sticky surface of the patch. Make sure there is no lotion, powder, cream, or make-up on the skin. Apply the patch and then press it with the palm of your hand for 10 seconds to make sure it sticks. Change the location of the patch each time you apply a new one. Do not apply a patch to skin that is injured, broken, or cut. Do not apply a patch to your breasts. Check the patch every day to make sure it is in place.
If the patch comes off partly or all the way, try to apply it again or apply a new patch. If it was loose less than 24 hours, no other form of birth control is needed. If the patch has peeled away for more than 24 hours, apply a new patch and start a new cycle. A second form of birth control should be used.
If the patch is not sticky or has stuck to material or itself, remove it and apply a new patch. Do not hold the patch in place with tape or wraps.
If you are switching from a contraceptive pill to using the patch, start the patch on the first day of your period. If you do not start your period after 5 days, you see your health care professional for a pregnancy test. If you start the patch later than the first day of your period, use a second method of birth control with the patch for the first 7 days.
If you have had a baby and are not breast-feeding, you should wait 4 weeks before you start this medicine. If you have not had a period after having your baby, you should make sure you are not pregnant before starting this medicine.
If you have a miscarriage or an abortion in the first trimester of your pregnancy, you may start norelgestromin/ethinyl estradiol right away. You do not need a second form of birth control. If you start this medicine 5 days or more after the miscarriage or abortion, you should use a second form of birth control with the patch for the first 7 days. If you have a miscarriage or abortion after the first trimester, you should wait 4 weeks before starting this medicine
If you have bleeding with the patch in place, continue to use the patches as usual. If the bleeding continues for 2****“3 cycles, call your health care professional. If you do not have your period during the time the patch is off stay on your regular schedule and call your health care professional.
If the patch is uncomfortable or causing irritation, change to a new patch in a new location. Change the patch again on your regular schedule. Do not use more than one patch at a time.
When you remove a patch, carefully fold it in half so that it sticks to itself and throw it away. There will still be some hormones on the patch. Do not touch the inside of the patch.
Your health care professional may begin your patch on the first day of your menstrual period (called Day-1 start) or on Sunday (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you forget to change a patch . 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.
Follow your doctor's orders or the directions on the label if you forget to change your patch. The following information includes only some of the ways to handle this. Your health care professional may want you to stop taking the medicine and use other birth control methods for the rest of the month until you have your menstrual period. Then your health care professional can tell you how to begin taking your medicine again.
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.
Tell the medical doctor or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment . Your doctor will decide whether you should continue taking this medicine.
Norelgestromin/ethinyl estradiol may not work as well for you if you weigh more than 198 pounds. Talk to your health care professional about the kind of birth control that is best for you.
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 health care professional 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 .
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
Side Effects of This Medicine
Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from using hormonal contraceptives. For most women, more problems occur because of pregnancy than will occur from using hormonal contraceptives. But for some women who have special health problems, hormonal contraceptives can cause some unwanted effects. Some of these unwanted effects include heart disease, heart attack, 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.
Other health problems that may be affected by using hormonal contraceptives are high blood pressure, high cholesterol, diabetes and being overweight.
Smoking cigarettes during the use of hormonal contraceptives has been found to greatly increase the chances of these serious side effects occurring. This risk increases with heavy smoking (15 or more cigarettes a day) or if you are over 35 years old. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking hormonal contraceptives .
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Use with caution around small children. The contraceptive patch may be a choking hazard if swallowed by a child.
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.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Last updated: Tue, 06 Jan 2009 00:20:03 GMT