Ethinyl estradiol and norelgestromin transdermal

Name: Ethinyl estradiol and norelgestromin transdermal

What is ethinyl estradiol and norelgestromin transdermal?

Ethinyl estradiol and norelgestromin contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norelgestromin transdermal (skin patch) is used as contraception to prevent pregnancy.

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

What happens if I miss a dose?

If you forget to change your patch at the end of the week, change it as soon as you remember. If it has been 24 hours or longer since your scheduled patch change, apply a new patch and start the cycle over (3 weeks wearing a weekly patch,1 week off). Do not use extra patches to make up the missed dose.

Missing a dose increases your risk of becoming pregnant and you may need to use back-up birth control. Follow the weekly patch schedule closely.

Ethinyl estradiol and norelgestromin transdermal side effects

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

Stop using ethinyl estradiol and norelgestromin transdermal and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with balance, sudden vision loss;

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • a change in the pattern or severity of migraine headaches;

  • swelling in your hands, ankles, or feet;

  • a breast lump; or

  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, stomach pain;

  • breast tenderness or swelling;

  • headache, anxiety, mood changes;

  • skin irritation, redness, itching, or swelling where the patch was worn;

  • menstrual cramps; or

  • irregular vaginal bleeding or spotting.

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.

What other drugs will affect ethinyl estradiol and norelgestromin transdermal?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ethinyl estradiol and norelgestromin transdermal, especially:

  • acetaminophen, ascorbic acid (vitamin C);

  • antifungal medicine--fluconazole, itraconazole, ketoconazole, voriconazole;

  • cholesterol-lowering medicines--atorvastatin, rosuvastatin; or

  • HIV or AIDS medicines--atazanavir, etravirine, indinavir.

This list is not complete. Other drugs may interact with ethinyl estradiol and norelgestromin transdermal, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make ethinyl estradiol and norelgestromin transdermal less effective, which may result in pregnancy. Not all possible interactions are listed in this medication guide.

Commonly used brand name(s)

In the U.S.

  • Ortho Evra
  • Xulane

Available Dosage Forms:

  • Patch, Extended Release

Therapeutic Class: Monophasic Contraceptive Combination

Pharmacologic Class: Progestin

Proper Use of ethinyl estradiol and norelgestromin

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 patient information leaflet will be given to you with your filled prescription, and will provide many details concerning the use of hormonal contraceptives. Read and follow the instructions carefully and ask your doctor if you need additional information or explanation.

This transdermal patch system is to be used for 28 days (four-week) cycle. A new patch is applied each week for 3 weeks (21 days), and week four is patch-free.

When you begin using norelgestromin and ethinyl estradiol transdermal, 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.

To use: Keep each patch in the package until you are ready to use it. Wash your hands with soap and water before and after applying a patch. Apply the patch to clean, dry, and intact skin on the abdomen or stomach, 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 doctor 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 a miscarriage or an abortion in the first trimester of your pregnancy, you may start norelgestromin/ethinyl estradiol transdermal right away. You do not need a second form of birth control. If you start ethinyl estradiol and norelgestromin 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 for 4 weeks before starting ethinyl estradiol and norelgestromin.

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 doctor. If you do not have your period during the time the patch is off, stay on your regular schedule and call your doctor.

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.

Dosing

The dose of ethinyl estradiol and norelgestromin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ethinyl estradiol and norelgestromin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor 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 doctor about changing schedules.

  • For transdermal dosage form (skin patch):
    • For contraception (to prevent pregnancy):
      • Adults—Apply one patch to the skin and keep it in place for 1 week. Apply a new patch at the beginning of week 2 and again at week 3. Always change the patch on the same day of the week. Do not use a patch during week 4. This is when you will have your period. Start a new patch 7 days after the last patch was removed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

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 doctor may want you to stop using the medicine and use other birth control methods for the rest of the month until you have your menstrual period. Then your doctor can tell you how to begin using your medicine again.

If you forget to apply your patch during the 1st week, apply it as soon as possible and start a new cycle. Use a second form of birth control for the first week of the new cycle. You will now have a new patch start day.

If you forget to change your patch in the 2nd or 3rd week for one or two days, change it as soon as you remember. No other form of birth control is needed. If you forget to change your patch in the 2nd or 3rd week for more than two days, change to a new patch and start a new cycle. Use a second form of birth control for the first week of the new cycle. If you forget to remove your patch at the end of the 3rd week, remove it as soon as possible and then start a new patch on your regular start day. You should never have the patch off for more than 7 days in a row.

Storage

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold the patch in half with the sticky sides together. Place it in a child-resistant container or a sealed bag. Make sure to dispose of it out of the reach of children and pets.

Dose Adjustments

There are not data in the literature to recommend a safe dosage of ethinyl estradiol and norelgestromin transdermal patch for this patient.

Dialysis

There are no data in the literature to recommend a safe dosage of ethinyl estradiol and norelgestromin transdermal patch for this patient.

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