ethinyl estradiol and norelgestromin (transdermal)

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Pronunciation: EH thi nil ESS tra DYE ol and nor ell JESS tro min

Brand: Xulane

What is the most important information I should know about ethinyl estradiol and norelgestromin transdermal?

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Your risk of serious blood clot may be higher with the use of birth control skin patches than with the use of birth control pills.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not use this medicine if you smoke and are older than 35 years of age.

You should not use this medicine if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, or if you have ever had breast or uterine cancer, a heart attack, a stroke, or a blood clot.

Do not use this medicine if you are pregnant or if you have recently had a baby.

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 should I discuss with my healthcare provider before using ethinyl estradiol and norelgestromin transdermal?

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using birth control. Your risk is also high when you restart this medicine after not using for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use this medicine if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before using this medicine.

You should not use this medicine if you have:

  • abnormal vaginal bleeding that has not been checked by a doctor;
  • history of heart attack, stroke, or blood clot;
  • heart problems such as uncontrolled valve disorder, or a rhythm disorder that causes blood clots in the heart;
  • an inherited blood-clotting disorder that causes your blood to clot more than normal;
  • untreated or uncontrolled high blood pressure;
  • problems with your eyes, kidneys or circulation caused by diabetes;
  • a history of hormone-related cancer such as breast or uterine cancer;
  • liver disease or cancer; or
  • severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35.

Your risk of serious blood clot may be higher with the use of birth control skin patches than with the use of birth control pills.

To make sure estradiol and norelgestromin transdermal is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure;
  • a history of depression;
  • gallbladder disease;
  • diabetes; or
  • a history of jaundice caused by pregnancy or birth control pills.

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

How should I use ethinyl estradiol and norelgestromin transdermal?

Follow all directions on your prescription label. Do not use more skin patches or wear them for longer than recommended by your doctor. You will apply your first patch on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

Place the patch on your skin and press it into place firmly for 10 seconds. Make sure the edges stick well. You will wear the patch for a full week.

Apply the patch to clean, dry skin on any of these areas: the outside of your upper arm, your stomach, your buttocks, or your upper back. Do not apply the patch to skin that is broken or irritated, or to a skin area that may be rubbed by tight clothing (such as a waistband).

Remove the patch and apply a new one on the same day each week for three weeks in a row. At the end of the third week, remove the patch and do not apply a new one for 7 full days. Your period should start during this time Do not allow more than 7 days to pass before starting your next 3-week patch cycle..

Check your patch every day to make sure it is sticking well. If a patch comes loose or falls off, throw it away and apply a new one. You may need to use back-up birth control, such as condoms or a spermicide, if a patch has been off for more than 24 hours. Follow your doctor's instructions.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

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

While using ethinyl estradiol and norelgestromin transdermal, you will need to visit your doctor regularly.

After removing a skin patch fold it in half, sticky side in, and throw it away in a place where children and pets cannot get to it. Do not flush a used patch down the toilet.

Store the skin patches at room temperature away from moisture and heat. Do not freeze or refrigerate. Keep each patch in its foil pouch until you are ready to apply it.

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using ethinyl estradiol and norelgestromin transdermal?

Do not smoke while using ethinyl estradiol and norelgestromin transdermal, especially if you are older than 35 years of age.

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

Avoid using creams, lotions, powders, or other medications on the skin where you apply the patch, or it may not stick to your skin.

This medicine will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What are the possible side effects of ethinyl estradiol and norelgestromin transdermal?

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.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norelgestromin.

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.

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