Ortho Evra

Generic Name: ethinyl estradiol and norelgestromin (EH thi nill ess tra DY ol and nor ell JESS tro min)

What is the most important information I should know about Ortho Evra?

Do not use Ortho Evra if you are pregnant or if you have recently had a baby. Do not use Ortho Evra if you have any of the following conditions: 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 ethinyl birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using Ortho Evra. Follow your doctor's instructions.

Using hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What is Ortho Evra?

Ortho Evra contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). Ortho Evra also causes changes in your cervical mucous 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 are used as contraception to prevent pregnancy.

Ortho Evra may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using Ortho Evra?

Ortho Evra 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 Ortho Evra (6 weeks if you are breast-feeding). Do not use Ortho Evra if you have:

• a history of a 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;
• severe migraine headaches;
• a heart valve disorder; or
• a history of jaundice caused by birth control pills.

Before using Ortho Evra, tell your doctor if you have any of the following conditions. You may not be able to use the medicine, or you may need a dosage adjustment or special tests during treatment.

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

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

How should I use Ortho Evra?

Use Ortho Evra exactly as it was prescribed for you. 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).

Tear open the foil pouch along the edge and peel it apart. Use your fingernail to grasp a corner flap of the skin patch and gently lift it out of the pouch.

Peel off one half of the plastic liner but try not to touch the sticky side of the patch. Place the patch on the skin area and remove the other half of the liner, pressing the patch 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 outisde 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. Check your patch every day to make sure it is sticking well to your skin. 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 need to use back-up birth control, such as condoms or a spermicide, when you first start using Ortho Evra. 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 to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using Ortho Evra for a short time. Any doctor or surgeon who treats you should know that you are using birth control skin patches.

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

Store the skin patches at room temperature away from moisture and heat. Keep each patch in its foil pouch until you are ready to apply it.

What happens if I miss a dose?

Apply a skin patch as soon as you remember. If it is almost time to apply your next patch, skip the missed dose and apply a patch on the next regularly scheduled day of the week. Do not use extra patches to make up the missed dose.

Missing a dose increases your risk of becoming pregnant. Follow the weekly patch schedule closely. Call your doctor or pharmacist if you have questions.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an overdose may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using Ortho Evra?

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.

What are the possible side effects of Ortho Evra?

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 headache, confusion, pain behind the eyes, 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;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, 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).

Continue using the patches and talk to your doctor if you have any of these less serious side effects:

• mild nausea, vomiting, bloating, stomach cramps;
• 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.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Ortho Evra?

Some drugs can make Ortho Evra less effective, which may result in pregnancy. Before using Ortho Evra, tell your doctor if you are using any of the following drugs:

• acetaminophen (Tylenol) or ascorbic acid (vitamin C);
• phenylbutazone (Azolid, Butazolidin);
• prednisolone (Orapred);
• theophylline (Respbid, Theo-Dur);
• cyclosporine (Neoral, Sandimmune, Gengraf);
• St. John's wort;
• antibiotics such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), griseofulvin (Grisactin, Grifulvin V, Fulvicin PG), minocycline (Minocin), penicillin (Veetids, Pen Vee K, Bicillin), rifampin (Rifadin), rifabutin (Mycobutin), tetracycline (Sumycin, Achromycin, Robitet), and others;
• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);
• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
• HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept).

There may be other drugs not listed that can affect Ortho Evra. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has additional information about Ortho Evra written for health professionals that you may read.

What does my medication look like?

Ethinyl estradiol and norelgestromin is available with a prescription under the brand name Ortho Evra. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
• Click here for more information on Ortho Evra from the manufacturer.