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Ortho Evra (Norelgestromin/Ethinyl Estradiol) Drug Information

What is Ortho Evra (Norelgestromin/Ethinyl Estradiol)?

Ortho Evra (Norelgestromin/Ethinyl Estradiol) contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication 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.

Ortho Evra (Norelgestromin/Ethinyl Estradiol) are used as contraception to prevent pregnancy.

Ortho Evra (Norelgestromin/Ethinyl Estradiol) may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Ortho Evra (Norelgestromin/Ethinyl Estradiol)?

Do not use this medication if you are pregnant or if you have recently had a baby. Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills. Using hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Many drugs can interact with birth control medication, and some can make it less effective. Tell your doctor about all other medications you are using.

What should I discuss with my healthcare provider before using Ortho Evra (Norelgestromin/Ethinyl Estradiol)?

This medication can cause birth defects. Do not use if you are pregnant. 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 medication (6 weeks if you are breast-feeding). Do not use this medication if you have:

  • a history of a stroke, blood clot, or coronary artery disease;
  • circulation problems (especially if caused by diabetes);
  • a hormone-related cancer such as breast or uterine cancer;
  • abnormal vaginal bleeding;
  • liver disease or liver cancer;
  • severe high blood pressure;
  • severe migraine headaches;
  • a heart valve disorder;
  • a history of jaundice caused by birth control pills; or
  • if you are 35 or older and you smoke.

To make sure you can safely take birth control pills, tell your doctor if you have any of these other conditions:

  • high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
  • diabetes;
  • high cholesterol or if you are overweight;
  • kidney disease;
  • a history of depression;
  • gallbladder disease;
  • seizures or epilepsy; or
  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

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

How should I use Ortho Evra (Norelgestromin/Ethinyl Estradiol)?

Use exactly as prescribed by your doctor. 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..

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

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.

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.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, tell the doctor or surgeon ahead of time that you are using this medication. You may need to stop wearing the patches for a short time.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

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.

Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using Ortho Evra (Norelgestromin/Ethinyl Estradiol)?

Do not smoke while using the birth control patch, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by using this medication.

This medication 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.

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

Grapefruit and grapefruit juice may interact with Ortho Evra (Norelgestromin/Ethinyl Estradiol) and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Ortho Evra (Norelgestromin/Ethinyl Estradiol) side effects

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 the patches and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects:

  • mild nausea, vomiting, bloating, stomach cramps;
  • unusual or unpleasant taste in your mouth;
  • breast pain, tenderness, or swelling;
  • freckles or darkening of facial skin;
  • increased hair growth, loss of scalp hair;
  • changes in weight or appetite;
  • problems with contact lenses;
  • vaginal itching or discharge;
  • changes in your menstrual periods, decreased sex drive; or
  • headache, nervousness, dizziness, tired feeling.

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.

Ortho Evra (Norelgestromin/Ethinyl Estradiol) Dosing Information

Usual Adult Dose for Contraception:

The initial dosage of ethinyl estradiol-norelgestromin transdermal patch for contraception is the placement of one patch on the skin of the upper outer arm, or abdomen, or buttocks, weekly for 3 weeks (21 total days), which is to remain in place for 7 days, the fourth week is drug free.

A new transdermal patch is placed on the skin one-week after the last patch was removed. Regardless of withdrawal bleed presence, the new transdermal patch is placed on the skin the same day (at any time) as it was done in the previous cycle.

If a patch is partially or completed detached for less than 1 day (up to 24 hours), reapply it to the same place or replace it with a new patch immediately. No backup contraception is needed. If this event occurs for more than 1 day (24 hours or more), or if the woman is not sure how long the patch has been detached, she should stop the current contraceptive cycle and start a new cycle immediately by applying a new patch. Backup contraception, such as condoms, spermicide, or diaphragm, must be used for the first week of the new cycle.

In women switching from a combination oral contraceptive, begin use of the patch on the first day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active (hormone-containing) tablet, pregnancy must be ruled out. If the patch is placed later than the first day of withdrawal bleeding, but within the 7 days from the last oral active tablet, a second method of contraception (non-hormonal) should be added for the first 7 days.

In women with a miscarriage or a complete first trimester abortion, begin use of the patch immediately. An additional method of contraception would not be needed if therapy is started immediately.

In women who choose not to breast-feed after childbirth, begin use of the patch no sooner than 4 weeks after childbirth. Postpartum women who have not had a period should add a second method of contraception (non-hormonal) for the first 7 days of patch use.

What other drugs will affect Ortho Evra (Norelgestromin/Ethinyl Estradiol)?

Many drugs can interact with birth control medication, and some can make it less effective. Below is just a partial list of these drugs. Tell your doctor if you are using:

  • acetaminophen (Tylenol) or ascorbic acid (vitamin C);
  • bosentan (Tracleer);
  • cyclosporine (Neoral, Sandimmune, Gengraf);
  • griseofulvin (Fulvicin);
  • prednisolone (Sterapred);
  • rosuvastatin (Crestor);
  • St. John's wort;
  • theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);
  • an antibiotic such as amoxicillin (Augmentin), ampicillin (Principen, Unasyn), doxycycline (Doryx, Oracea, Periostat, Vibramycin), tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap), and others;
  • antifungal medication such as fluconazole (Diflucan) or voriconazole (Vfend);
  • seizure medicines such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenytoin (Dilantin), topiramate (Topamax), and others;
  • a barbiturate such as phenobarbital (Solfoton), and others; or
  • HIV or AIDS medications, especially delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), or nevirapine (Viramune).

This list is not complete and other drugs may interact with Ortho Evra (Norelgestromin/Ethinyl Estradiol). Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.