Information on Ortho Evra

Pronounced: OR-thoe EV-rah
Generic ingredients: Ethinyl estradiol, Norelgestromin

Why is Ortho Evra prescribed?

Ortho Evra is a contraceptive skin patch. It contains estrogen and progestin, the same hormones found in many birth control pills. Fertility depends on regular fluctuations in the levels of these hormones. Contraceptives such as Ortho Evra reduce fertility by eliminating the fluctuations. Once applied to the skin, the Ortho Evra patch releases a steady supply of estrogen and progestin through the skin and into the bloodstream.

Most important fact about Ortho Evra

Cigarette smoking increases the risk of serious heart-related side effects (stroke, heart attack, blood clots, etc.) in women who use hormonal contraceptives. This risk increases with heavy smoking (15 or more cigarettes per day) and with age. There is an especially significant increase in heart disease risk in women over 35 years old who smoke and use hormonal birth control. Therefore, women who use Ortho Evra are strongly advised not to smoke.

How should you take Ortho Evra?

You should use three separate Ortho Evra patches during each 4-week menstrual cycle. Wear one patch a week for the first 3 weeks, then spend the fourth week patch-free. Your menstrual period should start during the fourth week.

--If you miss a dose...

If your patch becomes loose or falls off for less than 1 day, try to stick it back on, or apply a new patch immediately. If it's been missing for more than 1 day, or you're not sure how long it's been off, there's a chance you could become pregnant and you should use a backup method of birth control. Check the Ortho Evra patient informaton for instructions.

If you forget to change your patch at any time during the 4-week cycle, check the Ortho Evra patient information for instructions.

--Storage instructions...

Keep patches in their protective pouches until you're ready to wear them. Store at room temperature. Do not store in the refrigerator or freezer.

Used patches still contain some active hormones. Fold each patch so that it sticks to itself before throwing it away.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue using Ortho Evra.

Side effects may include:

• acne
• appetite changes
• bladder infection
• bleeding in spots during a menstrual period
• bloating
• blood clots
• breast tenderness or enlargement
• cataracts
• chest pain
• contact lens discomfort
• decreased flow of milk when used immediately after birth
• depression
• difficulty breathing
• dizziness
• fluid retention
• gallbladder disease
• growth of hair on the face or back
• growth of hair on the chest or stomach
• hair loss
• headache
• heart attack
• high blood pressure
• inflammation of the large intestine
• joint pain
• kidney trouble
• lack of menstrual periods
• leg pain
• liver tumors
• lumps in the breast
• menstrual pattern changes
• migraine
• muscle pain
• nausea
• nervousness
• pancreatitis
• premenstrual syndrome (PMS)
• reduced tolerance to carbohydrates
• secretion of breast milk
• sex drive changes
• skin infection
• skin rash or discoloration
• stomach cramps or pain
• stroke
• swelling
• temporary infertility
• unexplained bleeding in the vagina
• vaginal discharge
• vaginal infections (and/or burning and itching)
• visual disturbances
• vomiting
• weight gain or loss
• yellow skin or whites of eyes

Why should Ortho Evra NOT be prescribed?

Do not use Ortho Evra if you are pregnant (or think you might be). Also avoid it if the ingredients give you an allergic reaction or you suffer from headaches with neurological symptoms such as visual disturbances (pulsing lights and blind spots) and temporary numbness.

If you have ever had breast cancer or cancer in the reproductive organs or liver tumors, you should not take Ortho Evra. Avoid it, too, if you have or have ever had a stroke, heart disease, liver disease, angina (severe chest pain), or blood clots. It is also not recommended for women with significant high blood pressure or diabetes-related complications of the kidneys, eyes, nerves, or blood vessels.

Women who have had pregnancy-related jaundice (yellowing of the skin or whites of eyes) or jaundice stemming from previous use of hormonal contraceptives should not take Ortho Evra. You should also avoid it if you have undiagnosed and/or unexplained abnormal vaginal bleeding, or if you need prolonged bed rest after major surgery.

Do not use Ortho Evra if you are already taking birth control pills. Avoid the drug, too, if you are breastfeeding.

Special warnings about Ortho Evra

Hormonal contraceptives, including Ortho Evra, should be used with caution if you are over 40 years old; smoke tobacco; have liver, heart, gallbladder, or kidney disease; have high blood pressure, high cholesterol, diabetes, or epilepsy; or tend to be seriously overweight. Caution is also advised if you have blood circulation problems or have had a heart attack or stroke in the past. Be cautious, too, if you have problems with depression, migraine or other headaches, irregular menstrual periods, or visual disturbances.

There have been conflicting reports on whether using hormonal contraceptives increases the risk of breast cancer. It appears that using hormonal contraceptives may slightly increase the chance of breast cancer, particularly if they're used before age 20. After hormonal contraceptives are stopped, the risk begins to go back down. If you use Ortho Evra, you should examine your breasts monthly and have yearly breast exams by a doctor. Also tell your doctor if you have a family history of breast cancer or if you have had breast nodules, fibrocystic breast disease, or an abnormal mammogram.

You should also be aware that some experts think hormonal contraceptives may increase the risk of cervical cancer. This remains controversial, however. Many doctors think other factors are to blame.

Since the blood's clotting ability may be affected by hormonal contraceptives, your doctor may take you off Ortho Evra prior to surgery or during a period of prolonged bed rest. You should wait at least 4 weeks after having a baby before starting Ortho Evra; and if you're breastfeeding, wait until the child is weaned before starting the drug. If you are recovering from a second trimester miscarriage or abortion, talk to your doctor before using Ortho Evra.

If you develop a migraine or severe headache that does not let up or keeps recurring while you are taking Ortho Evra, check with your doctor. You may need to switch to a different form of birth control.

You should also be aware that hormonal contraceptives have been know to cause rare cases of noncancerous--but dangerous--liver tumors. In people prone to high cholesterol and similar problems, hormonal contraceptives have been known to raise triglyceride levels, leading to pancreatitis.

If you miss a menstrual period but have followed the Ortho Evra regimen correctly, contact your doctor but do not stop using the patches. If you miss a period and have not followed the regimen correctly, or if you miss two consecutive periods, you may be pregnant; stop using the patches and check with your doctor immediately to see if you are pregnant. Use another form of birth control while you're off the patch.

Ortho Evra may be less effective in women who weigh more than 198 pounds; if you fall into this category, ask your doctor which form of birth control is best for you.

Hormonal contraceptives do not protect against HIV infection (AIDS) or any other sexually transmitted disease. If there is a danger of infection, use a latex condom in addition to Ortho Evra.

Be sure to tell the doctor that you are taking Ortho Evra before having lab tests done, since certain blood tests may be affected by hormonal contraceptives.

Possible food and drug interactions when taking Ortho Evra

If hormonal contraceptives are taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Ortho Evra with the following:

• Acetaminophen (Tylenol)
• Antibiotics such as ampicillin and rifampin
• Anticonvulsants such as Dilantin, Felbatol, Tegretol, Trileptal, and Topamax
• Aspirin
• Atorvastatin (Lipitor)
• Barbiturates (phenobarbital, Seconal)
• Clofibrate (Questran)
• Cyclosporine (Neoral, Sandimmune)
• Diabetes drugs such as (Glucotrol)
• Folic acid
• Griseofulvin (Fulvicin, Grisactin)
• Itraconazole (Sporanox)
• Ketoconazole (Nizoral)
• Morphine (MS Contin)
• Phenylbutazone (Butazolidin)
• Prednisolone (Prelone, Pediapred)
• Protease inhibitors (HIV drugs such as Crixivan and Viracept)
• St. John's Wort
• Temazepam (Restoril)
• Theophylline (Theo-Dur, Slo-bid)
• Vitamin C

Remember, too, that hormonal contraceptives may affect tests for blood sugar levels and thyroid function and may cause an increase in blood triglyceride levels.

Special information if you are pregnant or breastfeeding

If you are pregnant (or think you might be), you should not use hormonal contraceptives, since they are not safe during pregnancy. For safety's sake, switch to a nonhormonal method of contraception if you miss a period and have not followed your patch schedule correctly. In addition, wait at least 4 weeks after delivery before starting Ortho Evra.

Nursing mothers should not use most hormonal contraceptives, since these drugs can appear in breast milk and may cause jaundice and enlarged breasts in nursing infants. In this situation, your doctor may advise you to use a different form of contraception while you are nursing your baby.

Recommended dosage

If you have any questions about how you should use Ortho Evra, consult your doctor or the patient instructions that come in the drug package. The following is a partial list of instructions for using Ortho Evra; it should not be used as a substitute for consultation with your doctor.

You should use three Ortho Evra patches during each 28-day cycle. You should apply a new patch each week for 3 weeks (21 total days). Do not apply a patch during the fourth week. Your menstrual period should start during this patch-free week.

Apply each new patch on the same day of the week. This will be your "patch change day." The patch can be applied on the first day of your menstrual cycle or on the first Sunday afterwards. The instructions below are for the first-Sunday schedule.

FOR A SUNDAY PATCH CHANGE SCHEDULE

1. Apply your first patch on the first Sunday after your menstrual period starts. You must use backup contraception for the first week of your cycle when starting Ortho Evra for the first time.
2. Choose a place on your body to put the patch where it won't be rubbed by tight clothing. You can apply the patch to your buttock, abdomen, upper outer arm, or upper back. Never put the patch on your breasts. To avoid irritation, apply each new patch to a different place on your skin.
3. Open the foil pouch that contains the patch by tearing along the top edge and one side edge. Peel the foil pouch apart and open it flat.
4. You will see that the patch is covered by a layer of clear plastic. It is important to remove the patch and the plastic together from the pouch. Using your fingernail, lift one corner of the patch and peel the patch and plastic off the foil liner. Sometimes patches can stick to the inside of the pouch; be careful not to accidentally remove the clear liner as you remove the patch.
5. Peel away half of the clear plastic liner. Be careful not to touch the exposed sticky surface of the patch with your fingers.
6. Apply the sticky side of the patch to clean, dry skin, then remove the other half of the clear plastic. Press firmly on the patch with the palm of your hand for 10 seconds, making sure the edges stick well. Run your finger around the edge of the patch to make sure it is sticking properly. Check your patch every day to make sure all the edges are sticking.
7. Wear the patch for 7 days. On the next Sunday (day 8), remove the used patch. Apply a new patch immediately. The used patch still contains some medicine; carefully fold it in half so that it sticks to itself before throwing it away.
8. Apply a new patch on the following Sunday (day 15). After 7 days, throw away the patch.
9. Do not wear a patch during the fourth week (day 22 through day 28). Your period should start during this week.
10. Begin your next 4-week cycle by applying a new patch on the Sunday after day 28, even if your period hasn't ended yet.

Overdosage

While any medication taken in excess can cause unwanted effects, the risk associated with Ortho Evra is minimal because the patch is designed to release a small amount of hormones at a slow, steady rate. Furthermore, even when young children have swallowed large amounts of oral hormonal contraceptives, they've suffered no ill effects. Nevertheless, if you suspect an overdose, seek medical help immediately.

Symptoms of Ortho Evra overdose may include:

• nausea
• vomiting
• vaginal bleeding in females