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DESCRIPTION
The goal of contraception (or birth control) is to prevent an unplanned pregnancy. The majority of methods of contraception enable sexually active couples to temporarily avoid pregnancy. Permanent birth control is accomplished through sterilization. Be sure you know and understand the different types of birth control available to you, the risks and benefits of each, and any side effects, so that you can make an informed choice.
Contraception Methods Compared
CONTRACEPTIVE PATCH - ORTHO-EVRA®
The Patch is marketed under the brand name Ortho Evra ® . It is a skin patch worn on the body. Ortho-Evra® (Norlegstromin/ethinyl estradiol) is a birth control patch about the size of a half-dollar. It contains both an estrogen and a progestin (0.75 mg ethinyl estradiol and 6.0 mg norelgestromin). You wear the patch on the arm, abdomen or buttock for 7 days in a row. Then you exchange it for a new patch, which you wear for another week, and so on. After three weeks (and three patches), the fourth week is patch-free.
The Patch releases two hormones, progestin and estrogen, into the bloodstream. This prevents the ovaries from releasing an egg (ovulation). It also thickens the cervical mucous, making it harder for sperm to enter the uterus.
The Patch is great for women who want an easy-to-use method of birth control. Patches are easy to apply, and adhere well to the skin. Women using the Patch have less bleeding and cramping during their periods. The Patch doesn't interfere with sex. It is not recommended for women who smoke, or women with a history of heart attack, stroke, or blood clots.
The Patch has been proven to be 99% effective, the same as the Pill, when used as directed. In typical use, it is 92% effective.
In the United States, the Patch requires a prescription. You can get the Patch from your health care provider, midwife, health department or family planning clinic.
ADVANTAGES
The specific advantages of using Ortho-Evra are:
- Convenient, once-a-week dosing. The Patch is easy to use; it is applied once a week for three weeks. No patch is worn on the fourth week.
- You can use it to control the timing and start of your periods.
- You don't have to remember a pill each day, as with oral contraceptives.
- Since the Patch releases a steady, consistent dose of hormones each month, it produces a lower incidence of headaches, nausea, breakthrough bleeding and breast tenderness then most oral contraceptives.
- The Patch causes fewer hormonal ups and downs than most hormonal methods.
- Doesn't require any interruption of sex play to protect against pregnancy.
DISADVANTAGES
The disadvantages of using the contraceptive patch are:
- Normally, the Patch stays in place. If it should fall off, follow the manufacturer's instructions for re-attachment. If it is off for more than 24 hours, you can become pregnant. See your health care provider for an alternate method of birth control.
- The Patch requires a prescription.
- Cigarette smoking increases the risk of high blood pressure and heart disease; women who use combination hormonal contraceptives are strongly advised not to smoke.
- The Patch does not protect you from HIV or other infections.
- Consult with your health care provider to determine whether you have any medical conditions that would be intensified while using the Patch.
PRECAUTIONS
Health care providers and midwives consider certain precautions when deciding whether a woman can safely use the hormone patch any other hormonal contraceptive.
The Ortho-Evra® Contraceptive Patch works by passing estrogen directly into the bloodstream, through the skin. Because oral contraceptives are taken daily, users of the Pill have estrogen levels that will rise and fall over time, whereas women wearing the Ortho Evra®Patch will experience a more constant, and potentially unsafe level of exposure to estrogen. The particular disadvantages of Ortho-Evra® are:
- It does not stick in about 5% of women.
- It can become partially or completely detached.
- it may cause an allergic skin reaction or irritation at the application site.
- More severe menstrual cramps and breast pain vs. pill users.
- The patch is less effective in women who weigh more than 90 kg (198 lbs)
Side effects from excess exposure to hormones in the patch include:
- Breast tenderness and enlargement.
- Headaches.
- Nausea.
- Vomiting.
- Shortness of breath.
- Dizziness.
- Jaundice (yellowing of skin).
- Rash.
- Chest pain.
- Fever.
- Fatigue.
- Vision problems, blurring of vision.
- Difficulty with speech.
- Loss of appetite.
- Numbness in extremities.
- Pain in the legs, head, or stomach.
- Abdominal cramps and bloating.
- Menstrual changes.
- Vaginal discharge.
The Ortho-Evra Patch® has been associated with increased risk of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE). Estrogen exposure can cause blood clots to form in the circulatory system, usually in the legs. When the blood clot becomes dislodged, it can travel to the heart, lungs, brain or other organs, causing hemorrhage, heart attack, stroke and death.
If you are wearing the Ortho-Evra Patch® and have experienced any of these warning signs, you should notify your physician immediately. Additionally, women over 35 and/or women who smoke are already at higher risk of blood clot-related problems - for this population, special care should be taken in the choice of contraceptive methods, and use of the Patch is particularly dangerous.
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of hormonal birth control methods. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal birth control methods should not smoke.
Ortho-Evra® should not be used by women who have a history of:
- Heart attack or stroke.
- Blood clots in the legs, lungs (pulmonary embolism), or eyes.
- Blood clots in the deep veins of the legs.
- Chest pain.
- Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina.
- Current unexplained vaginal bleeding.
- Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives.
- Liver tumor (benign or cancerous).
- Current or suspected pregnancy.
- Severe high blood pressure.
- Diabetes with complications of the kidneys, eyes, nerves, or blood vessels.
- An allergy to Ortho Evra or to any of its ingredients.
The Ortho-Evra patch may be less effective in preventing pregnancy in women weighing more than 198 pounds.
Reports of new information after Ortho Evra became available: As a result of further analysis by the FDA and the manufacturer, it has been found that users of Ortho Evra are exposed to about 60% more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the highest blood level of estrogen (peak blood levels) is about 25% lower with Ortho Evra than with typical birth control pills. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious side effects. ( Patient Information Sheet)
For more information:
FDA Updates Labeling for Ortho Evra Contraceptive Patch
Ortho Evra - Associated Press (7/16/05): AP Finds More Fatalities Than Expected
New York Post (5/8/05): Contra-Deception
2006 Ortho Evra Side Effects Lawsuit News
Lawsuit Against J&J Alleges Ortho Evra Contraceptive Patch...
Ortho Evra Web Site
GENERAL MEASURES
INSTRUCTIONS FOR USE
A complete gynecological exam with a documented PAP smear within 6 months prior to starting Ortho-Evra should be done.
How to use the contraceptive skin (transdermal) patch:
The skin (transdermal) patch is a highly effective method of birth control when it is used exactly as directed. The patch failure rate is the same as that of birth control pills. Only about 3 out of 1,000 women who use the patch exactly as directed for a year will become pregnant. On average, about 8 out of 100 patch users become pregnant per year. This is usually because the patch is not used as directed. Sometimes it is because the patch is less effective for women who weigh more than 198 lb (89.8 kg).1 It also can happen when the patch is exposed to direct sunlight or heat.
Talk to your health professional about what day to start using the patch. It is usually recommended that the first patch be placed on the first day of your next menstrual period. If the patch is started on any other day, use a backup contraceptive for 7 days. Start the patch on a day that is easy to remember.
The patch can be applied to your lower abdomen, buttocks, or upper body but not on the breasts. Apply a new patch once a week on the same day of the week for 3 weeks. The patch delivers the hormones daily over 7 days. Wear each patch continuously until you replace it the following week. No patch is worn during the fourth week, so you have a menstrual period.
Steps to follow:
Day One Start: Apply your first patch during the first 24 hours of your menstrual period. No back-up method is needed. Then just change your patch once a week on the same day that you started, and at about the same time of day, for three consecutive weeks. You do not need to apply a patch during the fourth week.
Sunday Start: Wait until the first Sunday after your menstrual period begins. With this option, you must use back-up contraception such as condoms or spermicide for the first 7 days of the first cycle only. Then just change your patch once a week every Sunday, at about the same time of day you first applied the patch, for three consecutive weeks. You do not need to apply a patch during the fourth week.
Points to Remember:
If a patch seems loose partially lifts up off my skin or falls off?
A small number of women have reported that the patch has partially or completely come off. If this happens before your patch is due to be changed, apply a replacement patch right away.
For less than 24 hours: You should try to reapply it or apply a new birth control patch immediately. No back-up contraception is needed and your "Patch Change Day" will remain the same. You can reapply the patch by following these instructions:
- Do not try to reapply a birth control patch if it's no longer sticky, if it has been stuck to itself or another surface, if it has other material stuck to it or if it has become loose or has fallen off before.
- Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the edges stick well.
- Then run your fingers around the edge of the patch.
- Do not use tapes or wraps to keep the birth control patch in place.
If the birth control patch does not stick well, remove it and then apply a replacement birth control patch. This patch should be replaced on the original "Patch-Change Day." Single replacement patches are available through your pharmacist.
For more than 24 hours or if you are not sure for how long: You may become pregnant. Start a new four-week cycle immediately by applying new patch. You now have a new Day 1 and a new "Patch Change Day." You must use back-up birth control, such as a condom, spermicide or diaphragm for the first week of your new cycle.
If you have trouble remembering to change your patch, or if the patch falls off repeatedly, contact your health care provider to discuss switching to another form of birth control.
Do not decorate or cut the patch: To ensure the effectiveness of ORTHO EVRA, you should not write on the patch or alter the patch in any way. Modifying the patch may affect the amount of medication that is delivered through the skin and into the bloodstream, which may increase the risk of becoming pregnant.
Lotions (moisturizing lotions, tanning lotions) may affect the ORTHO EVRA birth control patch: Always apply your birth control patch to clean, dry skin. Do not use creams, oils, powder or make-up on your skin where you will put a patch or near a patch you are wearing. It may cause the patch to become loose.
Dirt or a dark ring may form around the birth control patch: It is not recommended that you clean the edges of the patch prior to removal on the "Patch Change Day." Lifting the edges of the patch may cause it to become loose or fall off. Using creams, oils, or powders near the patch may cause it to become loose. On your "Patch Change Day," when you remove the birth control patch, if a small ring of adhesive is left on your skin, you can remove it by rubbing a small amount of baby oil on the area.
If the Ortho Evra Patch is left on too long: If the patch has been left on for an extra week or fewer (four weeks total or less), remove and replace it after a one-week patch-free break. If the patch has been left in place for more than 7 days, you may not be adequately protected from pregnancy and you must check to be sure you are not pregnant. You must use an extra method of birth control, such as male condoms or spermicide, until the new Ortho Evra Patch has been in place for seven days in a row.
To remove and discard ORTHO EVRA: When removing your used patch, simply lift one corner and quickly peel back. If a small ring of adhesive is left on your skin, remove it by rubbing a small amount of baby oil on the area. A small number of women have some mild to moderate skin irritation from the patch. The used patch still contains some medicine—throw it away after carefully folding it in half so that it sticks to itself. When you remove a patch you should always dispose of it carefully. Because of environmental concerns about hormones in the water supply, don't flush it down the toilet.
Storage: ORTHO EVRA birth control patches should be stored in their protective pouches. Apply immediately to skin upon removal from the protective pouch. Store at room temperature, (25°C or 77°F), with short variations in other temperatures permitted (to 15-30°C, 59-86°59-F). Do not store in the refrigerator or freezer.
Avoid direct sunlight or heat on the patch: Direct sunlight or high heat can increase, then lower, the amount of hormone released from a patch. This can give you a big dose at the time and leave less hormone for the patch to release later in the week. This increases your risk of pregnancy. Also avoid using a tanning bed, heating pad, electric blanket, hot tub, or sauna while you are using a hormone patch.
Patch warnings: The patch delivers more estrogen than low-dose birth control pills do. In general, more estrogen raises the chance of blood clots in the legs and lungs, heart attack, and stroke. It is not yet known whether women who use the patch are more likely to have these serious problems. However, there seems to be several pending lawsuits regarding the patch and serious side effects some women experience.
Don't Use Ortho Evra if:
- You smoke. Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day. Women who use combination hormonal contraceptives, including NuvaRing®, are strongly advised not to smoke.
- You think you may be pregnant.
- You have or have ever had blood clots in your legs, lungs, or eyes.
- You have known or suspected breast cancer or cancer of the endometrium, cervix or vagina now or in the past.
- You have unexplained vaginal bleeding.
- Jaundice during past use of oral contraceptives, or during pregnancy.
Women with any of the following conditions should be checked often by their health care provider if they choose to use Ortho-Evra:
- A family history of breast cancer.
- Breast nodules, fibrocystic disease, an abnormal breast x-ray or abnormal mammogram diabetes.
- High blood pressure.
- High cholesterol or triglycerides.
- Migraine headaches or epilepsy.
- Depression.
- Gallbladder or kidney disease.
- Impending major surgery (discuss with your health care provider about whether or not s/he may want you to stop the patch for awhile to reduce the risk of a possible blood clot)
Overdose with this medication is highly unlikely. However, if overdose is suspected, remove the patch and contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
Do not share this medication patch with others.
Keep all laboratory and medical appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your health care provider's instructions for examining your own breasts, and report any lumps immediately. Consult your health care provider for more details.
MEDICATION INTERACTIONS
Ortho-Evra Medication Interactions:
Your health care providers or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because very serious interactions may occur: aromatase inhibitors (e.g., anastrazole, exemestane), sodium tetradecyl sulfate, troleandomycin. If you are currently using any of these medications listed above, tell your health care provider or pharmacist before starting this medication.
Certain drugs can decrease the effectiveness of combination-type birth control by decreasing the amount of birth control hormones in your system. This can result in pregnancy. These drugs include: many antibiotics (e.g., cephalosporins, chloramphenicol, macrolides such as erythromycin, penicillins, sulfas), aprepitant, bexarotene, bosentan, dapsone, griseofulvin, certain HIV protease inhibitors (e.g., amprenavir, nelfinavir, ritonavir), modafinil, nevirapine, rifamycins (e.g., rifampin), many seizure medications (e.g., barbiturates, carbamazepine, phenytoin, lamotrigine, topiramate), St. John's wort. Consult your health care provider or pharmacist for details, and ask them if you should use additional reliable birth control methods while taking any of the drugs mentioned above.
Before taking this medication, tell your health care provider of all prescription and non-prescription medications you may use, especially of: acetaminophen, ascorbic acid (vitamin C), aspirin, atorvastatin, azole antifungals (e.g., itraconazole, ketoconazole), certain benzodiazepines (e.g., diazepam, lorazepam, temazepam), clofibric acid, corticosteroids (e.g., prednisolone), cyclosporine, metoprolol, morphine, phenylbutazone, raloxifene, tamoxifen, theophylline, medication for low thyroid (hypothyroidism).
This medication can affect the results of certain lab tests (e.g., blood tests such as glucose, clotting factors, lipids, thyroid). Make sure laboratory personnel and all your health care providers know you use this medication.
Estrogen-related Interactions:
If you take certain other drugs while using estrogen, the effects of either could be increased, decreased, or altered. It is especially important to check with your health care provider before taking the following:
- Alcohol
- Barbiturates such as phenobarbital and Seconal
- Blood thinners such as Coumadin
- Cimetidine (Tagamet)
- Clarithromycin (Biaxin)
- Dantrolene (Dantrium)
- Epilepsy drugs such as Tegretol and Dilantin
- Erythromycin (E-Mycin, Ery-Tab)
- Grapefruit juice
- Itraconazole (Sporanox)
- Ketoconazole (Nizoral)
- Rifampin (Rifadin)
- Ritonavir (Norvir)
- St. John's wort
- Steroids such as Deltasone
- Tricyclic antidepressants such as Elavil and Tofranil
FYI- Hormone Replacement & Contraceptive Patch Links:
Pharma-Help.com: Ortho-Evra
PDR-Health: Estrogen Skin Patches Information
MedicineNet.com: Testosterone Transdermal Patches Information
Consumer Drug Information: Estradiol & Norethrindrone
ESTROGEN & BREASTFEEDING
Estrogens (or other hormone contraceptive) should not be used during pregnancy. Estrogen should not be used immediately after childbirth. Use of estrogens during pregnancy has been linked to reproductive tract problems in the children. If you are pregnant or plan to become pregnant, notify your health care provider or midwife immediately. Estrogens decrease the quantity and quality of breast milk. If this medication is essential to your health, your health care provider or midwife may advise you to discontinue breastfeeding until your treatment is finished.
NOTIFY YOUR MIDWIFE OR HEALTH CARE PROVIDER IF...
You are interested in hormone patches for contraception.
If you experience any of the following symptoms, you should seek medical care immediately.A - Abdominal pain (severe)
C - Chest pain- shortness of breath, coughing up blood
H - Headache (severe), numbness or weakness in arms or legs
E - Eye problems (vision loss, blurring, flashing lights)
S - Severe leg pain in calf or thighAfter beginning to use the patch you have any unexpected side effects develop such as heavy vaginal bleeding. See list under side effects.
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